[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"solid-tumor-malignancies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:solid-tumor-malignancies":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,33,0,25,[9,46,79,104,135,161,186,208,235,255,286,310,343,373,397,427,455,485,510,533,558,579,612,638,657],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100526603","phase-1-a-first-in-human-phase-1-study-evaluating-oral-tacc3-ppi-inhibitor-ao-252-in-advanced-solid-tumors-with-or-without-brain-metastases-100526603",false,"NCT06136884","A First-In-Human, Phase 1 Study Evaluating Oral TACC3 PPI Inhibitor, AO-252, in Advanced Solid Tumors With or Without Brain Metastases","A Phase 1, Open-Label, Dose-escalation and Dose-Expansion Study Evaluating AO-252, a Protein-Protein Interaction Inhibitor of TACC3, in Patients With Advanced Solid Tumors With or Without Brain Metastases","Inclusion Criteria:\n\n1. Adults ≥ 18 years of age.\n2. Patient has histologically or cytologically confirmed metastatic or locally advanced unresectable solid tumors with TP53 mutation\u002Floss and with\u002Fwithout brain metastasis. Patients must have relapsed\u002Fbe refractory to at least 1 line of systemic therapy in the metastatic setting (excluding melanoma).\n3. Prostate cancer:\n\n   1. mCRPC with histologic confirmation of adenocarcinoma. mCRPC with neuroendocrine features or mixed histology are excluded\n   2. Patients will be enrolled irrespective of the TP53 status\n   3. Participant must have prostate specific antigen (PSA) of ≥ 2 ng\u002FmL\n   4. Is surgically or medically castrated, with testosterone levels of less than 50 ng\u002FdL\n   5. Patients who progressed on at least 1 prior novel androgen receptor AR-targeted therapy (that is, abiraterone acetate, apalutamide, enzalutamide, darolutamide), and or at least 1 prior systemic chemotherapy (e.g., docetaxel)\n4. Solid tumors with brain metastasis:\n\n   1. Histologically or cytologically confirmed metastatic or locally advanced unresectable solid tumors excluding melanoma with TP53 mutation\u002Floss and tumor must have relapsed\u002Fbe refractory to at least 1 line of systemic therapy. Untreated brain metastases not requiring immediate local CNS therapy\n   2. Previously treated brain metastases with progression of previous lesions or new lesions, but not requiring immediate local CNS therapy\n   3. At least one measurable untreated brain lesion ≥0.5 cm and \\\u003C3.0 cm in the longest axis\n   4. Prior SRS radiosurgery (must be completed within 7 days of study treatment initiation) is allowed as long as the previous treatment volume does not overlap with the current targets.\n5. Measurable disease per RECIST v1.1 criteria. For mCRPC patients, tumor response will be evaluated using RECIST version 1.1 (soft tissue) and PCWG-3 criteria (bone) and efficacy endpoints will also include radiographic progression-free survival (rPFS), PSA50 response and PSA progression\n6. Adequate bone marrow reserve, cardiac, liver, and renal function:\n\n   1. Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm3\n   2. Platelet count ≥ 100,000\u002Fmm3\n   3. Hemoglobin ≥ 9 g\u002FdL\n   4. Bilirubin ≤ 1.5 × upper limit of normal (ULN) or direct bilirubin ≤ ULN for patients with total bilirubin levels \\>1.5 × ULN\n   5. Alanine aminotransferase (ALT, SGPT) and aspartate aminotransferase (AST, SGOT) ≤ 2.5 × ULN (≤ 5 × ULN if liver metastases are present)\n   6. INR ≤ 1.5 × ULN unless patient is receiving anticoagulant therapy and PT or aPTT is within therapeutic range of intended use of anticoagulants\n   7. Creatinine clearance ≥ 60 mL\u002Fmin (by Cockroft Gault formula).\n7. Female patients of child-bearing potential must have a negative serum pregnancy test and use at least 1 form of acceptable birth control method listed below as approved by the Investigator before initiating study treatment and for 3 months after the last dose of study drug.\n\n   1. Sterilization\n   2. Any hormonal contraceptives (non-CYP 3A4 inhibitors) associated with inhibition of ovulation\n   3. IUD (intrauterine device) or intrauterine hormone releasing system\n8. Male patients must be sterilized or use a form of barrier contraception, such as condoms with spermicide, during the study and for 3 months after the last dose of study drug.\n9. Life expectancy of ≥ 3 months.\n10. Ability to provide written informed consent.\n11. An Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.\n\nExclusion Criteria:\n\n1. Patients with symptomatic brain metastases requiring treatment and\u002For leptomeningeal disease\n2. Patients with a previous history of another malignancy (other than cured basal cell or squamous cell carcinoma of the skin or cured in-situ carcinoma) within 3 years of study entry.\n3. Patients with uncontrolled pleural effusions, pericardial effusion, or ascites that do not resolve.\n4. Patients with gastrointestinal tract disease causing the inability to take oral medication (e.g., swallowing difficulties, malabsorption syndromes, extensive small bowel resection \\[\\> 100cm\\], gastric bypass surgery).\n5. Pregnant or breast-feeding patients or any patient with child-bearing potential not using adequate contraception.\n6. Known human immunodeficiency virus, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (excluding cured HBV and\u002For cured HCV infection).\n7. Presence of any serious concomitant systemic disorders incompatible with the study in the opinion of the Investigator (e.g., uncontrolled congestive heart failure, active infection).\n8. Radiation therapy to \\> 30% of bone marrow within 3 months before study entry.\n9. Patients with clinically significant autoimmune disease, either currently present of present within 2 years, including a current requirement for systemic immunosuppressive therapy equivalent to \\> 10 mg\u002Fprednisone daily (local immunosuppressive therapy such as inhaled or topical corticosteroids is allowed).\n\n11\\. Patients with abnormal or clinically significant electrocardiogram (ECG) abnormality, including but not limited to a confirmed corrected QT interval using Fridericia's formula (QTcF) \\> 470 msec.\n\n12\\. Patient has received systemic anticancer therapy within 3 weeks or 5 half-lives, whichever is shorter.\n\n13\\. Patients must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline.\n\n14\\. Any of the following conditions (on-study testing is not required):\n\na. Known HIV-infected patients unless on effective anti-retroviral therapy with an undetectable viral load within 6 months and no opportunistic infection within the past 12 months, or b. Known or suspected hepatitis B if active infection (patients with chronic hepatitis B infection must have an undetectable HBV viral load on suppressive therapy, if indicated; positive surface antibody alone is not an exclusion), or c. Known or suspected hepatitis C infection that has not been treated and cured unless currently on treatment with an undetectable viral load.\n\n15\\. Administration of strong or moderate cytochrome (CYP) 3A4 inhibitors and inducers within 14 days or 5 half-lives (whichever is shorter) prior to the administration of study drug.","ALL","18 Years",{"count":20,"type":21},86,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of this study is to assess the safety, tolerability and efficacy of the study drug AO-252 and identify the best dose for use in future studies.",[27,28],"Solid Tumor Malignancies","Brain Metastases From Solid Tumors",[30,31,32],"brain metastases","solid tumors","AO-252","RECRUITING","2026-08-13",{"date":36,"type":37},"2026-08-17","ACTUAL",{"date":39,"type":37},"2023-11-02",{"date":41,"type":21},"2028-01-27",{"name":43,"class":44},"A2A Pharmaceuticals Inc.","INDUSTRY",6,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100647086","pralsetinib-ddi-study-in-patients-with-advanced-or-metastatic-solid-tumors-100647086","NCT07704658","Pralsetinib DDI Study in Patients With Advanced or Metastatic Solid Tumors","A Multi-center, Open-label, Drug-drug Interaction Study to Evaluate the Effect of Pralsetinib (Gavreto) on the Pharmacokinetics of CYP3A4, CYP2C8, and CYP2C9 Substrates, and Hormones Estradiol\u002FNorethisterone Acetate in Patients With Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Must be willing and able to participate and comply with all study requirements and to provide signed and dated written informed consent\n* Adult male or female ≥ 18 years of age at the time of signing the informed consent form.\n* Must have a body mass index (BMI) ≥ 18 and ≤ 32 kg\u002Fm² and a minimum body weight of 50 kg at screening.\n* Must have an Eastern Cooperative Oncology Group performance status ≤ 2.\n* Must have recovered from the non-hematologic toxic effects of prior treatment to Grade ≤ 1, or baseline value (excluding infertility, alopecia, or Grade 1 neuropathy)\n* Must have a confirmed diagnosis of advanced or metastatic solid tumor that has relapsed after, or is not responsive to, standard therapies and harbors an oncogenic RET fusion or mutation as determined by a validated test.\n* Must have adequate organ function, defined by the following:\n\n  1. Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL.\n  2. Platelet count ≥ 75 × 10⁹\u002FL.\n  3. Hemoglobin ≥ 9 g\u002FdL.\n  4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN), or ≤ 5 × ULN in patients with known liver metastases.\n  5. Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN in patients with Gilbert syndrome).\n  6. Creatinine clearance ≥ 40 mL\u002Fmin using the Cockcroft-Gault equation.\n  7. Serum phosphorus ≤ 5.5 mg\u002FdL.\n  8. International normalized ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (aPTT) within normal laboratory limits.\n* Must be at least 4 weeks from major surgery, radiotherapy, chemotherapy, immunotherapy, kinase\u002Ftargeted therapy, or gene therapy prior to the first dose of study treatment and recovered from treatment-related toxicities to ≤ Grade 1 (excluding alopecia). Must be ≥ 6 weeks since last treatment if they received a long-acting agent such as a nitrosourea, mitomycin, or monoclonal antibodies. In general, a treatment interval of two half-lives should be considered and discussed with the Sponsor. (Concurrent cancer therapy of any type is not permitted).\n* Female patients may participate if they are not of childbearing potential (e.g., surgically sterile or postmenopausal).\n* Male patients with female partners of childbearing potential must agree to use highly effective contraception during study treatment and for 90 days after the last dose of study treatment.\n* Male patients must refrain from sperm donation during study treatment and for 90 days after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, electrocardiogram (ECG), or laboratory tests at screening that, in the investigator's judgment, are likely to interfere with the objectives of the trial or the safety of the patient.\n* Surgery (e.g., gastric bypass) or medical condition that may significantly affect absorption of study medications, as judged by the investigator.\n* History of pneumonitis within the last 12 months.\n* History of active or latent tuberculosis (TB), regardless of treatment history, or a positive screening test for latent Mycobacterium tuberculosis infection by QuantiFERON® TB Gold. Indeterminate results may be confirmed by repeat testing or by a purified protein derivative (PPD) skin test.\n* Serious infection requiring intravenous or systemic antibiotics within 7 days prior to initiation of study treatment, or any active infection that, in the opinion of the investigator, could impact patient safety (e.g., COVID-19 or influenza).\n* Clinically significant, uncontrolled cardiovascular disease, including:\n\n  1. New York Heart Association (NYHA) Class III or IV congestive heart failure.\n  2. Myocardial infarction or unstable angina within the previous 6 months, clinically significant uncontrolled arrhythmias, including bradyarrhythmias that may cause QT prolongation (e.g., second- or third-degree heart block).\n  3. Uncontrolled hypertension (i.e., mean systolic blood pressure ≥180 mmHg and\u002For diastolic blood pressure ≥110 mmHg on 3 repeated measurements) or clinically significant hypotension (i.e., systolic blood pressure \\\u003C90 mmHg and\u002For diastolic blood pressure \\\u003C50 mmHg) or severe episodes of orthostatic hypotension.\n  4. History of prolonged QT syndrome or torsades de pointes, or familial history of long QT syndrome.\n  5. QTcF ≥470 ms on at least 2 ECGs performed \\>30 minutes apart.\n* Central nervous system (CNS) metastases or primary CNS tumor.\n* Use of systemic corticosteroids within 4 weeks prior to first dose of study treatment.\n* More than 30 Gy of radiotherapy to the lung within 6 months prior to check-in.\n* History of multiple and\u002For severe allergies to drugs or foods, or history of severe anaphylactic reaction.\n* Use of prohibited medications or procedures\n* Medical conditions, treatments, or underlying diseases that constitute contraindications to the use of study substrates or probe drugs\n* Ingestion of alcohol within 72 hours prior to first study drug administration and during the study period.\n* Participation in another investigational drug trial within 30 days prior to study drug administration (or within 5 half-lives of the investigational drug, whichever is longer) or exposure to more than 3 investigational agents within 12 months prior to study drug administration.\n* Positive serology for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody at screening (a negative PCR test overrides a positive serology).\n* Positive human immunodeficiency virus (HIV) test at screening.\n* Positive urine drug screen (unless attributable to concomitant medication) or positive alcohol breath test at screening and\u002For Day -1.\n* Patients who are legally incapacitated, have limited legal capacity, or are otherwise considered vulnerable.\n* Female patients who are pregnant or breastfeeding.\n* Patients who plan to become pregnant or father a child (including ova or sperm donation) during the study or within 3 months after the last dose of study drug.\n* Known allergy or history of hypersensitivity to study drug(s) or their excipients.\n* Concomitant use of strong or moderate CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and\u002For CYP3A4 inhibitors within 7 days or 5 half-lives (whichever is longer) prior to first dose of study treatment.\n* Concomitant use of strong or moderate CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and\u002For CYP3A4 inducers within 14 days or 5 half-lives (whichever is longer) prior to first dose of study treatment.\n* History of or active clinically significant cardiovascular, respiratory, gastrointestinal, renal, hepatic, neurological, psychiatric, musculoskeletal, genitourinary, dermatologic, hematologic, or other disorder that, in the investigator's judgment, could interfere with study participation or the absorption, metabolism, or excretion of study treatment.\n* History of prior second malignancy unless disease-free for ≥ 12 months or considered surgically cured. Patients with nonmelanoma skin cancers or with carcinomas in situ at any time following curative intent surgery and low grade, early-stage prostate cancer (Gleason score 6 or below, stage 1 or 2) with no requirement for therapy at any time prior to the study, or previously resected are also eligible.",{"count":54,"type":21},12,[56],"PHASE4","An open-label drug-drug interaction study to evaluate the effects of pralsetinib (Gavreto) on the pharmacokinetics of a CYP450 probe substrate cocktail and, in female participants, a hormonal probe substrate, in participants with rearranged during transfection (RET) fusion- or mutation-positive solid tumors",[59,60,27,61],"NSCLC (Non-small Cell Lung Cancer)","Thyroid Cancer","Advanced Malignancies",[63,64,65,66,67,68],"Oncology","Drug-Drug Interactions","Medical Oncology","RET Fusion Positive","RET Gene Mutation","Pharmacokinetic (PK)","2026-08-07",{"date":71,"type":37},"2026-08-10",{"date":73,"type":37},"2026-03-04",{"date":75,"type":21},"2027-08-30",{"name":77,"class":44},"Rigel Pharmaceuticals",2,{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":94,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":78},"100630364","phase-4-olutasidenib-ddi-study-in-patients-with-idh1-mutation-positive-malignancies-100630364","NCT07486713","Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies","A Multi-Center, Open-Label, Drug-Drug Interaction Study to Evaluate the Effect of Olutasidenib on the Pharmacokinetics of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Substrates in Patients With IDH1 Mutation-Positive Malignancies Being Treated With Olutasidenib","Inclusion Criteria:\n\n* Adult male or female ≥ 18 years of age at the time of signing the informed consent form\n* Must have an Eastern Cooperative Oncology Group performance status ≤ 2.\n* Must have recovered from the non-hematologic toxic effects of prior treatment to Grade ≤ 1, or baseline value (excluding infertility, alopecia, or Grade 1 neuropathy)\n* Must have a diagnosis of IDH1m+ malignancy to be treated with olutasidenib (e.g. acute myeloid leukemia \\[AML\\], gastrointestinal \\[GI\\] cancers, glioma). Patient should not have received olutasidenib within the 2 weeks prior to the first dose of study drug.\n* Patient must have an adequate organ function, defined by the following:\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values ≤ 2.5 × upper limit of normal (ULN).\n* Bilirubin ≤ 1.5× ULN (≤ 3 × ULN in patients with Gilbert Syndrome) or ≤ 3 × ULN for patients with AML involvement.\n* Creatinine clearance ≥ 30 mL\u002Fmin using Cockcroft-Gault equation.\n* Female patients who are women of childbearing potential (WOCBP) must have a negative serum (β-hCG) pregnancy test at screening and negative urine test (positive urine tests are to be confirmed by serum test) documented within the 24-hour period prior to the first dose of study drug. WOCBP are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, or ovarian suppression.\n* WOCBP, must agree to use two methods of birth control (e.g. hormonal and a barrier method such as a condom), or must be considered highly unlikely to conceive during the dosing period and for 3 months after last study treatment.\n* Male patients with female partners of childbearing potential may be enrolled if they both agree to use highly effective methods of contraception during the dosing period and for 3 months after last study treatment.\n* Male patients must refrain from donating sperm during the dosing period and for 3 months after last study treatment.\n\nExclusion Criteria:\n\n* Female patients who are pregnant or breastfeeding.\n* Patients who are active smokers. Those who have ceased smoking \\> 1 month before the Screening Visit will be allowed.\n* Ingestion of alcohol within 72 hours prior to first study drug administration and during the study period.\n* Any patient's who plans to become pregnant or father a child (including ova or sperm donation) while enrolled in this study or within 3 months after last dose of study drug.\n* Known allergy or history of hypersensitivity to study drugs or their excipients.\n* Human immunodeficiency virus (HIV) positivity.\n* Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or by RNA polymerase chain reaction (PCR) at screening.\n* Any patient's with a serious infection requiring intravenous or systemic antibiotics within 7 days prior to initiation of study treatment, or any active infection that, in the opinion of the Investigator, could impact patient's safety (e.g. COVID-19).\n* Use of concomitant medications that are moderate or strong CYP1A2, 2B6, 2C8, 2C9, 2C19, and\u002For 3A4 inhibitors within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug\n* Use of concomitant medications that are moderate or strong CYP1A2, 2B6, 2C8, 2C9, 2C19, and\u002For 3A4 inducers within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.\n* History of or active, clinically significant, cardiovascular, respiratory, GI, renal, hepatic, neurological, psychiatric, musculoskeletal, genitourinary, dermatological, or other disorder that, in the Investigator's opinion (or following review by the Sponsor), could affect the conduct of the study or the absorption, metabolism or excretion of the study treatment.\n* If less than the minimum time has elapsed from prior anticancer treatment to first dose of study treatment as follows:\n\n  1. Cancer therapies, including chemotherapy, radiation, biologics or kinase inhibitors, or major surgery within 4 weeks prior to the first scheduled study treatment; for longer acting agents such as nitrosourea, mitomycin or antibody therapies, a minimum of 6 weeks.\n  2. Use of investigational agents within 4 weeks prior to study enrollment (within 6 weeks if the treatment was with a long-acting agent).\n* History of prior second malignancy unless disease-free for ≥ 12 months or considered surgically cured. Patients with nonmelanoma skin cancers or with carcinomas in situ at any time following curative intent surgery and low grade, early-stage prostate cancer (Gleason score 6 or below, stage 1 or 2) with no requirement for therapy at any time prior to the study, or previously resected are also eligible.\n* Patients with symptomatic central nervous system metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy.\n* Marked baseline prolongation of QT\u002FQTc interval (e.g., repeated demonstration of a QTc interval \\> 480 milliseconds \\[msec\\]) (Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grade 1) using Fridericia's QT correction formula.\n* Patients with New York Heart Association Class III or IV heart failure.",{"count":87,"type":21},16,[56],"A open-label drug-drug interaction (DDI) study to evaluate the effects of olutasidenib on the pharmacokinetics (PK) of a CYP450 and OATP1B1 probe substrate cocktail in participants with IDH1 mutation-positive malignancies.",[91,92,93,27],"AML (Acute Myeloid Leukemia)","Glioma","Cholangiocarcinoma",[95,96,63,64],"IDH1 Mutation","Hematology and Oncology",{"date":98,"type":37},"2026-08-11",{"date":100,"type":37},"2026-02-23",{"date":102,"type":21},"2027-06-30",{"name":77,"class":44},{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":17,"minAge":111,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":116,"conditions":117,"keywords":122,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":4},"100650619","phase-1-grace-a-phase-12a-study-of-vtru200-in-relapsedrefractory-aml-high-risk-mds-dlbcl-post-cart-failure-and-advanced-solid-tumors-100650619","NCT07749976","GRACE: A Phase 1\u002F2a Study of VTRU200 in Relapsed\u002FRefractory AML, High-risk MDS, DLBCL Post CART Failure and Advanced Solid Tumors","A Phase I\u002FIIa Dose Escalation and Expansion Study of VTRU200 in Adult and Pediatric Participants With Relapsed\u002FRefractory AML, HR-MDS, DLBCL Post-CART Failure and Advanced Solid Tumors","Inclusion Criteria:\n\n* 1\\. Adults (≥18 years) with\n\nI. Pathologically confirmed acute myeloid leukemia (AML) according to WHO 2022 criteria. Relapsed or refractory AML, defined as either:\n\n1. Refractory AML: Failure to achieve CR, CRh, or CRi after at least 2 courses of intensive induction therapy.\n2. Relapsed AML: Recurrence after prior CR, CRh, or CRi, documented by one or more of the following: Bone marrow blasts \\>5% by morphologic assessment; persistent reappearance of blasts in peripheral blood by morphologic assessment II. HR-MDS: Pathologically confirmed myelodysplastic syndrome (MDS) according to WHO 2022 criteria, with high-risk disease defined as IPSS-R high-risk or very high-risk (score \\>4.5). Ineligible for allogeneic hematopoietic stem cell transplantation.\n\nIII. DLBCL post-CAR T: histologically confirmed DLBCL per WHO 2022 criteria and relapsed or refractory disease after prior CART therapy. Qualifying post-CAR T treatment failure must be documented at least 1 month after CAR T infusion and include no metabolic response, first metabolic progressive disease, or first relapse after prior response. Prior CART infusion must have occurred at least 1 month before screening. Participants must not be in partial metabolic response or complete metabolic response at screening and must have measurable disease on PET\u002FCT (preferred) or CT\u002FMRI, defined as at least 1 nodal lesion \\>1.5 cm or at least 1 extranodal lesion \\>1.0 cm; if PET is used, lesions must be FDG-avid and consistent with active lymphoma IV. Advanced solid tumors 2. Children (6 months-11 years) and adolescents (12-17 years) with R\u002FR-AML.\n\n1. Children and adolescent refractory AML: Bone marrow contains 1% blasts by multiparametic flow cytometry (MFC) at the end of 2 cycles of induction therapy\n2. Children and adolescent relapsed AML: A single bone marrow sample showing 5% leukemic blasts by MFC, fluorescence in situ hybridization (FISH) testing or other molecular method, or a single bone marrow sample with at least two tests showing 1% blasts such as by MFC, karyotypic abnormality with at least one metaphase similar or identical to diagnosis, FISH abnormality identical to one present at diagnosis (above level of sensitivity of specific FISH probe) or polymerase chain reaction (PCR) or next generation sequencing (NGS)-based demonstration of leukemogenic lesion (e.g., fusion, mutation) identical to diagnosis and is quantifiably 1% 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or Karnofsky Performance Score (KPS) ≥50% 4. Adequate organ function: I. Hepatic: Serum AST\u002FALT ≤2.5×ULN and total bilirubin ≤1.5×ULN (≤3×ULN if Gilbert's syndrome) II. Renal: Serum creatinine ≤1.5×ULN; Calculated CrCl: ≥40 mL\u002Fmin (Cockcroft-Gault \\[adults\\]; Schwartz formula \\[adolescents\\]; apply if serum creatinine is borderline) III. Cardiac: ejection fraction ≥ 50% and no evidence of pericardial effusion as determined by ECHO IV. Hematologic: WBC count must be ≤20 × 10⁹\u002FL prior to the first dose of study treatment and before each dose in Cycle 1; patients with WBC \\>20 × 10⁹\u002FL may receive cytoreduction with hydroxyurea (up to 4 g\u002Fday) and\u002For leukapheresis per protocol to achieve this threshold, with hydroxyurea held ≥12-24 hours before each study treatment dose 5. Females of childbearing potential must have a negative serum or urine pregnancy test 6. Adults: written informed consent. Adolescents: written patient assent plus parental\u002Fguardian informed consent.\n\n   7\\. Prior treatment with an investigational agent is permitted provided that at least 5 half-lives have elapsed and all treatment-related toxicities have resolved to Grade ≤1 (except alopecia). Prior T-cell engaging, checkpoint inhibitor, or cellular therapies require a minimum washout of 8 weeks.\n\n   Exclusion Criteria:\n   * 1\\. Active central nervous system (CNS) disease requiring treatment. 2. Uncontrolled or clinically significant baseline neurologic disorder (e.g., uncontrolled seizures or severe cognitive impairment\u002Fdelirium), significant psychiatric illness or active substance abuse.\n\n     3\\. Uncontrolled infections including persistent bacteremia\u002Ffungemia despite appropriate therapy, progressive invasive fungal infection, or uncontrolled viral infection with end-organ disease. Active tuberculosis.\n\n     4\\. Concurrent malignancy requiring active systemic therapy. 5. Cytotoxic chemotherapy within 14 days prior to first dose. Targeted anti-leukemic therapy within 7-14 days prior to first dose. Radiotherapy within 14 days prior to first dose (except limited-field palliative radiotherapy). Prior CD3-engaging therapy.\n\n     6\\. T-cell depleting therapy (ATG, alemtuzumab, or equivalent) within 6 months prior to enrollment 7. Severe uncontrolled cardiovascular disease (e.g., NYHA class III\u002FIV heart failure, unstable angina or MI within 6 months, uncontrolled arrhythmia). Severe uncontrolled pulmonary disease (e.g., requiring high-flow oxygen or ventilatory support).\n\n     8\\. Systemic corticosteroids \\>10 mg\u002Fday prednisone equivalent within 7 days prior to first dose.\n\n     9\\. Active autoimmune disease requiring systemic immunosuppression within the past 12 months.\n\n     10\\. Prior allogeneic transplant within 3 months or active graft-versus-host disease (GVHD).\n\n     11\\. Primary immunodeficiency (congenital immunodeficiency disorder requiring ongoing medical management).\n\n     12\\. Known HIV infection. Hepatitis B: HBsAg positive (chronic HBV infection). Hepatitis C: anti-HCV positive (HCV exposure).\n\n     13\\. Pregnant or breastfeeding 14. Known congenital or acquired bleeding disorder, including hemophilia A\u002FB or von Willebrand disease, or other clinically significant coagulopathy 15. History of severe allergic reaction to immunotherapy","6 Months",{"count":113,"type":21},108,[24,115],"PHASE2","About this study\n\nThis is the first study of VTRU200 in people. The main purpose of this study is to find a safe dose of VTRU200 and learn how the medicine behaves in the body. Researchers will also look for early signs that it may help treat cancer.\n\nVTRU200 is an experimental immunotherapy. It is designed to help the body's immune system find and destroy cancer cells while limiting effects on healthy cells.\n\nUnlike many cancer treatments that target a single protein, VTRU200 recognizes stress signals that are commonly found on cancer cells. These signals include certain sugars (called glycans) and fats (called phospholipids) that are present on many types of cancer cells but are uncommon on normal healthy cells. VTRU200 also attaches to immune cells called T cells and helps direct them to attack cancer cells.\n\nBecause VTRU200 targets features that are shared by many cancers, it may continue to work even if cancer cells lose or change individual proteins that other treatments depend on.\n\nWho can take part?\n\nThis study is for people with certain blood cancers that have come back after treatment or have not responded to available treatments. These include:\n\nAcute myeloid leukemia (AML) Higher-risk myelodysplastic syndromes (HR-MDS) Diffuse large B-cell lymphoma (DLBCL) that has returned after CAR T-cell therapy\n\nLater parts of the study may also include adolescents and children with AML.\n\nWhat will happen during the study?\n\nParticipants will receive VTRU200 through a vein (intravenous infusion).\n\nThe study will begin by giving small doses to help determine the safest dose for future participants. If those doses are well tolerated, later participants may receive higher doses.\n\nResearchers will:\n\nMonitor participants closely for side effects. Perform blood tests to measure how VTRU200 moves through and leaves the body. Measure how the immune system responds to treatment. Check whether the cancer shrinks, disappears, or remains under control.\n\nParticipants may receive multiple treatment cycles if they continue to benefit and do not have unacceptable side effects.\n\nWhat are the possible benefits?\n\nVTRU200 may or may not help participants. Information learned from this study may help develop new treatments for people with these cancers in the future.\n\nWhat are the possible risks?\n\nBecause VTRU200 is being tested in humans for the first time, not all side effects are known.\n\nPossible risks include reactions related to activation of the immune system, infusion-related reactions, laboratory test changes, and other side effects. Participants will be monitored closely throughout the study, and medical care will be available if side effects occur.\n\nBrief Study Description\n\nThis first-in-human, open-label, Phase 1\u002F2a study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity of VTRU200 in participants with relapsed or refractory acute myeloid leukemia (AML), higher-risk myelodysplastic syndromes (HR-MDS), or diffuse large B-cell lymphoma (DLBCL) following CAR T-cell therapy. VTRU200 is an investigational trispecific T-cell engager that binds stress-associated glycans, phosphatidylserine, and CD3 to redirect T cells toward cancer cells. The Phase 1 dose-escalation portion will determine the recommended Phase 2 dose (RP2D), followed by disease-specific expansion cohorts to further evaluate safety and preliminary antitumor activity.\n\nWhy is this research important?\n\nMany blood cancers eventually stop responding to available treatments. Cancer cells can escape therapy by changing or losing the proteins that many current medicines target.\n\nVTRU200 is designed to recognize stress-related features that many cancer cells share rather than relying on a single protein target. Researchers hope this approach may reduce the chance of treatment resistance while limiting damage to healthy cells. This study will help determine whether VTRU200 can be given safely and whether it shows early signs of helping people with difficult-to-treat blood cancers.",[118,119,120,27,121],"Acute Myeloid Leukemia","Diffuse Large B Cell Lymphoma (DLBCL)","High Risk Myelodysplastic Syndrome","Pediatric Acute Myeloid Leukemia",[123,124],"T cell engager","TCE","NOT_YET_RECRUITING","2026-08-03",{"date":128,"type":37},"2026-08-06",{"date":130,"type":21},"2027-01",{"date":132,"type":21},"2029-01",{"name":134,"class":44},"Vitruviae",{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":145,"conditions":146,"keywords":147,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":160},"100650392","phase-1-a-clinical-study-of-go321-in-patients-with-advanced-solid-tumors-100650392","NCT07748117","A Clinical Study of GO321 in Patients With Advanced Solid Tumors","A Phase I Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of GO321 Recombinant Oncolytic Virus Injection in Patients With Advanced Refractory Solid Tumors.","Inclusion Criteria:\n\n* Age 18 years old and above, regardless of gender.\n* Histologically or cytologically confirmed advanced malignant solid tumors that are refractory to or have failed standard therapy (including disease progression and\u002For intolerance to toxicity), or for which no standard therapy is available.\n* For patients with malignant ascites secondary to malignant tumors (e.g., ovarian cancer, gastrointestinal solid malignancies) who are planned to receive intracavitary injection, the following criteria must be met:\n\n  * a. Malignant ascites is determined by the investigator to be caused by cancer cell dissemination, and not complicated by ascites due to other etiologies;\n  * b. Recurrence of ≥ Grade 2 ascites within 4 weeks after at least one prior local therapy (including paracentesis, intraperitoneal chemotherapy, peritoneovenous shunt, hyperthermic intraperitoneal chemotherapy, etc.);\n  * c. Large-volume peritoneal effusion confirmed by computed tomography (CT) or ultrasound, with a clinical indication for local therapeutic intervention targeting the ascites.\n* Patients scheduled for intratumoral injection must meet the following requirements: At least one evaluable lesion confirmed by local imaging per RECIST v1.1 that is amenable to intratumoral injection. A lesion suitable for intratumoral injection (with or without CT\u002Fultrasound guidance) is defined as a palpable mass or a mass visible by CT\u002Fultrasound that can be injected under CT\u002Fultrasound guidance, located in the skin, subcutaneous tissue, or deep-seated regions, with a longest diameter ≥ 1.0 cm (or short axis ≥ 1.5 cm if a lymph node), and deemed appropriate for intratumoral injection by the investigator. If the injection site has been previously irradiated, eligibility may be considered after discussion with the sponsor.\n* Eastern Cooperative Oncology Group (ECOG) score ≤2.\n* Expected survival time ≥3 months.\n* Study participants had adequate organ function at screening\u002Fbaseline, and the laboratory indicators met the following criteria:\n\n  * a. Hematopoietic system (no previous blood transfusion or hematopoietic stimulating factor therapy within 14 days) : absolute neutrophil count (ANC) ≥1.5E+09\u002FL; Hemoglobin (Hgb) ≥90g\u002FL; Platelet count (Plt) ≥75E+09\u002FL.\n  * b. Liver function: serum total bilirubin (TBIL) ≤1.5×ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN, with liver metastasis TBIL≤3×ULN, ALT and AST≤5×ULN; Serum albumin ≥2.8 g\u002FdL (Subjects may receive albumin supplementation to meet these laboratory criteria).\n  * c. Renal function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (according to Cockroft-Gault formula) \\>50mL\u002Fmin.\n  * d. Coagulation: international normalized ratio (INR) ≤1.5, activated partial thromboplastin time (APTT) ≤1.5×ULN.\n* Study participants were willing and able to comply with protocol requirements for the duration of the trial, including but not limited to receiving treatment, use effective contraception throughout trial participation and for 6 months after the last study drug administration, and undergoing regular follow-up and examinations.\n\nExclusion Criteria:\n\n* Female participants who were pregnant or lactating.\n* Presence of another malignancy within the previous 2 years, except for cancers with a low risk of metastasis and death (5-year survival rate, \\>90%), such as adequately treated basal-cell or squamous-cell skin cancer or carcinoma in situ of the cervix and other cancers in situ.\n* Adverse events from prior anti-tumor therapy have not recovered to Grade ≤ 1 per CTCAE v6.0, or to the levels specified in the inclusion\u002Fexclusion criteria (with the exception of alopecia, skin hyperpigmentation, or other toxicities deemed by the investigator to have no safety risk). Participants with chronic Grade 2 toxicity may be eligible after discussion with the sponsor, provided the toxicity is asymptomatic or adequately controlled with stable medications.\n* Received nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational product; received oral fluoropyrimidines or small-molecule targeted agents within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose; received traditional Chinese herbal medicines or proprietary Chinese medicines with anti-tumor indications within 2 weeks prior to the first dose; received other systemic anti-tumor therapies, including chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy, etc., within 3 weeks or 5 half-lives (whichever is shorter) prior to the first dose.\n* Presence of any of the following infections or diseases:\n\n  * a. Active hepatitis B (HBsAg positive and\u002For HBcAb positive with an HBV DNA test value greater than the upper limit of normal); Active hepatitis C (anti-HCV antibody positive for further HCV RNA positive).\n  * b. A known history of immunodeficiency virus (HIV) disease or HIV antibody positive or active syphilis.\n  * c. Evidence of clinically significant immunodeficiency such as a primary immunodeficiency state such as severe combined immunodeficiency (SCID); Opportunistic bacterial infection.\n* Have a history of active autoimmune disease requiring systemic therapy such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc., or have been receiving long-term systemic steroids (prednisone \\>10 mg\u002F day or equivalent dose of the same drug) or any other form of immunosuppressive therapy within 14 days before the first use of the investigational drug. The following patients are NOT excluded:\n\n  * a. Subjects with clinically stable autoimmune thyroid disease\n  * b. Patients receiving topical\u002Finhaled corticosteroids (ocular, intra-articular, intranasal formulations)\n  * c. Short-course glucocorticoids (≤3 days) used prophylactically (e.g., contrast allergy prevention)\n  * d. Patients receiving physiological hormone replacement doses.\n* Received allogeneic tissue or solid organ transplantation.\n* A history of severe cardiovascular and cerebrovascular disease, including but not limited to:\n\n  * a. New York Heart Association (NYHA) class ≥II congestive heart failure.\n  * b. left ventricular ejection fraction (LVEF) \\\u003C50%.\n  * c. QT interval corrected with Fridericia's method (QTcF) \\>470 ms or syndrome of prolonged QT interval.\n  * d. Acute coronary syndrome, aortic dissection, major arrhythmia, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events occurred within 6 months before the first dose.\n  * e. Presence of uncontrolled hypertension despite treatment (systolic BP\\>160 mmHg or diastolic BP\\>100 mmHg, as judged by the investigator).\n  * f. Occurrence of Grade ≥ 3 bleeding events within 6 months prior to the first dose; or current presence of \\> Grade 2 bleeding, hemangioma\u002Fvascular malformation, tumor apoplexy, tumor invasion of blood vessels, or active gastrointestinal ulcer, esophageal varices, or central nervous system (CNS) metastases with intracranial lesions that have potential bleeding risk, as determined by the investigator to have a significant risk of hemorrhage.\n* History of severe skin diseases requiring systemic therapy within the past 2 years, such as eczema, atopic dermatitis, burns, seborrheic dermatitis, psoriasis, severe acne, etc.\n* Patients with history of hypersensitivity or anaphylactic reactions (including immediate severe hypersensitivity reactions) of CTCAE v6.0 Grade \\> 3 following prior use of any drug or biologic product.\n* Requirement for anticoagulant or antiplatelet therapy that cannot be interrupted prior to intratumoral injection, including: aspirin that cannot be discontinued within 7 days prior to injection; coumarins that cannot be discontinued within 7 days prior to injection; direct thrombin inhibitors (dabigatran) or direct Factor Xa inhibitors (rivaroxaban, apixaban, and edoxaban) that cannot be discontinued within 4 days prior to injection; low-molecular-weight heparin (LMWH) that cannot be discontinued within 24 hours prior to injection; and unfractionated heparin (UFH) that cannot be discontinued for more than 4 hours prior to injection.\n* Use of immunomodulatory agents within 14 days prior to the first dose of the investigational product, including but not limited to thymosin, IL-2, IFN, etc.\n* Presence of other conditions requiring systemic anti-infective treatment within 4 weeks prior to the first dose of the investigational product, or active local infection at the target lesion intended for injection within 4 weeks prior to the first dose, including but not limited to hospitalization due to infectious complications, bacteremia, severe pneumonia, or active tuberculosis.\n* Receipt of other investigational drugs or therapies not yet approved for marketing within 4 weeks prior to the first dose of the investigational product, or receipt of live or live-attenuated vaccines within 4 weeks prior to the first dose.\n* Study participants who had undergone major surgery requiring hospitalization within 4 weeks before the first use of the investigational drug, or who were expected to undergo major surgery during the trial.\n* Inability to discontinue concomitant use of sensitive substrate drugs with a narrow therapeutic index that are metabolized by CYP450 enzymes within 5 half-lives prior to the first dose of the investigational product.\n* Any known mental illness or substance abuse that may interfere with the participant's ability to cooperate with the trial.\n* According to the evaluation of the investigators, the treatment risks are high, including but not limited to the high risk of bleeding, possible damage to the surrounding important tissue structures, the risk of shock caused by dizzy with blood and needles, and the risk of aggravating local infection.\n* If study participants plan to participate in another clinical trial during the trial period, plan to leave the trial site, or otherwise are not suitable for participation in the trial as assessed by the investigator.",{"count":143,"type":21},21,[24],"The goal of this clinical trial is to learn about the safety and tolerability of GO321 recombinant oncolytic virus injection, and if GO321 recombinant oncolytic virus injection works to treat advanced solid tumors in adults whose cancers have progressed after standard-of-care therapy. It will also learn about the pharmacokinetic features, viral shedding, immunogenicity of GO321, immune markers, and genomic and proteomic changes in patients. The main questions it aims to answer are: What safety issues and tolerability limitations do participants experience when receiving GO321 via intratumoral or intracavitary injection? Does GO321 have preliminary anti-tumor efficacy against advanced solid tumors resistant to standard treatment? What changes take place in viral distribution, viral shedding, immunity, blood immune markers, tumor or blood genomics and proteomics after GO321 administration? Researchers will assess different doses and dosing schedules of GO321 given by intratumoral or intracavitary injection across two study phases to find a suitable administration dose and regimen and verify the study endpoints.\n\nParticipants will:\n\nReceive either a single injection of GO321 at different dose levels (in Part 1) or repeated GO321 injections at the recommended Phase 2 dose (in Part 2) by intratumoral or intracavitary routes; Complete scheduled hospital visits to undergo laboratory tests, imaging examinations and biological sample collection; Have their safety indicators, anti-tumor response, viral parameters, immune indicators and molecular profiles tracked throughout the study.",[27],[148,149,150],"GO321","Solid tumor malignancies","Oncolytic Viral Therapy","2026-07-31",{"date":153,"type":37},"2026-08-05",{"date":155,"type":21},"2026-08-15",{"date":157,"type":21},"2028-12-31",{"name":159,"class":44},"GeneSail Biotech (Shanghai) Co., Ltd.",1,{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":22,"phases":170,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":160},"100629600","exploring-the-feasibility-of-cerebrospinal-fluid-csf-and-blood-plasma-liquid-biopsy-in-patients-with-metastatic-solid-tumours-and-primary-central-nervous-system-cns-tumours-a-pilot-study-100629600","NCT07476781","Exploring the Feasibility of Cerebrospinal Fluid (CSF) and Blood Plasma Liquid Biopsy in Patients With Metastatic Solid Tumours and Primary Central Nervous System (CNS) Tumours: A Pilot Study","ECLIPSE","Inclusion Criteria:\n\n* Diagnosed with a solid tumour in one of the following scenarios:\n\n  1. Patients in Cohort A will have previously untreated or progressing leptomeningeal metastatic disease (LMD) with or without parenchymal brain metastases (BrM).\n  2. Patients in Cohort B will have previously untreated or BrM but no evidence of LMD.\n  3. Patients in Cohort C will have progressing extra-cranial metastatic disease with no LMD or BrM.\n  4. Patients in Cohort D will have primary CNS tumours (such as, but not limited to, meningioma, glioblastoma, astrocytoma, ependymoma, and other rare histologies).\n* Patient is suitable for lumbar puncture and\u002For has an Ommaya reservoir that is accessible for CSF collection.\n* Patient is eligible at any time point in their treatment course, including whether or not they have already started treatment for LMD. Considering the poor prognosis associated with LMD, rapid clinical deterioration, and the fact that available local and systemic therapies have not been shown to completely eradicate LMD, there is a high likelihood of detecting CSF biomarkers regardless of the timing of assessment. This flexible enrollment strategy is particularly important to support feasibility and recruitment in this less common and clinically challenging population. However, efforts will be made to collect CSF samples prior to treatment initiation and\u002For at the time of disease progression whenever possible.\n* Patients with active brain metastases, defined as newly diagnosed and previously untreated lesions, or lesions that were previously treated and are now progressing.\n* Patients who were previously enrolled in the study and had negative CSF biomarkers may be re-enrolled at a later time point (e.g., upon progression of CNS disease).\n\nExclusion Criteria:\n\n* Inability to understand or unwillingness to provide written informed consent (language barriers are not exclusionary; the use of a translator is permitted).\n* Patients with contraindications to lumbar puncture (e.g., infection at the LP site, uncontrolled bleeding diathesis \\> 1.5\\], severe thrombocytopenia \\[platelet count \\\u003C40,000\u002FµL\\], use of anticoagulant or antiplatelet medications cannot be safely interrupted, significant mass effect with risk of herniation, or presence of vertebral hardware)",{"count":169,"type":21},60,[171],"NA","This is a prospective, single-centre feasibility study of CSF ctDNA conducted at the Sunnybrook Odette Cancer Centre (SOCC), Toronto, Canada, including multiple solid tumor, stratified into cohorts according to CNS disease involvement, including leptomeningeal disease (Cohort A), parenchymal brain metastases (Cohort B), and no evidence of CNS metastases (Cohort C).",[27,174,175,176],"Brain Metastasases","Leptomeningeal Disease (LMD)","Central Nervous System","2026-07-29",{"date":151,"type":37},{"date":180,"type":37},"2025-12-12",{"date":182,"type":21},"2026-12",{"name":184,"class":185},"Sunnybrook Health Sciences Centre","OTHER",{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":193,"enrollmentInfo":194,"targetDuration":4,"studyType":22,"phases":196,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":160},"100647145","phase-1-gkl-006allo-injection-in-patients-with-advanced-solid-tumors-100647145","NCT07704515","GKL-006Allo Injection in Patients With Advanced Solid Tumors","A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GKL-006Allo Injection in Patients With Solid Tumors","Inclusion Criteria:\n\n* Able to understand and voluntarily sign the informed consent form.\n* Aged 18 to 75 years.\n* Histologically, cytologically or clinical confirmed unresectable locally advanced or metastatic solid tumor that has failed standard therapy.\n* At least one measurable tumor lesion during screening according to RECIST v1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and life expectancy of at least 3 months.\n* Adequate hematologic and organ function.\n* Participants of childbearing potential must agree to use at least one medically accepted contraceptive method during study treatment and for 6 months after the end of study treatment.\n* Able to communicate with the investigator, comply with study visits, and understand and follow study requirements.\n\nExclusion Criteria:\n\n* Recently received radical radiotherapy or other anti-tumor therapy.\n* Known hypersensitivity to any component of the study treatment.\n* Prior history or concurrent malignancy that has not been cured.\n* Active infection, known or suspected autoimmune disease.\n* Last anti-tumor treatment toxicity not yet recovered to suitable status.\n* Other organ dysfunction or situations deemed inappropriate by the investigator.","75 Years",{"count":195,"type":21},27,[24],"This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of GKL-006Allo Injection in participants with advanced solid tumors.",[27],"2026-07-14",{"date":201,"type":37},"2026-07-15",{"date":203,"type":21},"2026-08-30",{"date":205,"type":21},"2029-01-31",{"name":207,"class":44},"Beijing Gene Key Life Technology Co., Ltd",{"id":209,"slug":210,"hasResults":12,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":215,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":217,"briefSummary":219,"conditions":220,"keywords":221,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":160},"100647452","early-phase-1-clinical-evaluation-of-68gaga-ffd-pet-imaging-in-healthy-volunteers-and-patients-with-solid-tumors-100647452","NCT07708103","Clinical Evaluation of [68Ga]Ga-FFD PET Imaging in Healthy Volunteers and Patients With Solid Tumors","A Single-Center, Prospective, Open-Label Clinical Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry, and Diagnostic Performance of [68Ga]Ga-FFD PET Imaging in Healthy Volunteers and Adult Patients With Solid Tumors","Inclusion Criteria:\n\n* Written informed consent obtained before any study-specific procedures. Adults aged 18 years or older.\n* Healthy volunteers or patients with histologically, cytologically, or clinically confirmed malignant solid tumors.\n* ECOG performance status of 0-1 for patients.\n* Clinical indication for \\^18F-FDG PET\u002FCT imaging (patient cohort only).\n* Adequate organ function.\n* Willing and able to comply with all study procedures.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* Known hypersensitivity to gallium-containing radiopharmaceuticals or any component of the investigational product.\n* Clinically significant uncontrolled cardiovascular, hepatic, renal, hematologic, neurological, or psychiatric disease.\n* Active uncontrolled infection requiring systemic treatment.\n* Receipt of investigational drugs or participation in another interventional clinical study within 30 days before enrollment.\n* Previous anticancer therapy that does not satisfy the protocol-defined washout period (patient cohort only).\n* Inability to undergo PET\u002FCT imaging or comply with study procedures. Any condition that, in the investigator's judgment, would compromise participant safety or interfere with study assessments.",true,{"count":54,"type":21},[218],"EARLY_PHASE1","This is a prospective, single-center, open-label clinical study designed to evaluate the safety, biodistribution, radiation dosimetry, and diagnostic performance of \\[68Ga\\]Ga-FFD PET imaging. The study consists of two cohorts: healthy volunteers and adult patients with histologically or clinically confirmed malignant solid tumors. Healthy volunteers will undergo serial PET imaging to evaluate tracer biodistribution, pharmacokinetics, and radiation dosimetry. Patients will undergo \\[68Ga\\]Ga-FFD PET imaging in addition to standard-of-care \\^18F-FDG PET imaging for assessment of lesion detection and diagnostic performance. Safety will be evaluated through adverse event monitoring, vital signs, laboratory tests, physical examinations, and electrocardiography. Diagnostic performance will be assessed using histopathology, conventional imaging, and clinical follow-up as the reference standard.",[27],[222,223,224,225],"pet","Solid Tumor","Biodistribution","Diagnostic Imaging","2026-07-12",{"date":228,"type":37},"2026-07-16",{"date":230,"type":21},"2026-07-30",{"date":232,"type":21},"2027-07-30",{"name":234,"class":185},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":193,"enrollmentInfo":242,"targetDuration":4,"studyType":22,"phases":244,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":250,"completionDateStruct":251,"leadSponsor":253,"locationsCount":78},"100647155","phase-1-a-phase-iii-study-of-fg-m108-plus-fg-b901-in-advanced-cldn182-positive-solid-tumors-100647155","NCT07704866","A Phase I\u002FII Study of FG-M108 Plus FG-B901 in Advanced CLDN18.2-Positive Solid Tumors","An Open-Label, Multicenter Phase I\u002FII Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of FG-M108 Injection in Combination With FG-B901 Injection in Patients With Unresectable Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Voluntarily sign the informed consent form, understand the study, are willing to comply with and have the ability to complete all trial procedures;\n* Age 18-75 years (inclusive), any gender;\n* Have histologically or cytologically confirmed locally advanced or metastatic solid tumors, and have failed standard therapy, or are intolerant to standard therapy, or for whom standard therapy is not available;\n* CLDN18.2 positive (defined as ≥10% of tumor cells showing membrane staining ≥1+ by central laboratory IHC)\n* ECOG 0-1\n* Expected survival ≥3 months;\n* Have at least one measurable tumor lesion according to RECIST 1.1 criteria;\n* Adequate cardiac, bone marrow, liver, renal function;\n\nExclusion Criteria:\n\n* Have received a live vaccine within 3 months prior to the first dose;\n* Received radiotherapy within 4 weeks before the first dose\n* Received Chinese herbal medicine with antitumor indications within 2 weeks before the first dose\n* Previously received any therapy targeting CLDN18.2\n* History of other malignancies within 3 years before the first dose\n* Experienced Grade ≥3 immune-related adverse events (irAEs) from prior immunotherapy or discontinued immunotherapy due to irAEs, or have irAEs from prior immunotherapy that the investigator judges to still have clinical impact\n* Toxicity from prior antitumor therapy has not recovered to NCI CTCAE v5.0 Grade 0-1\n* History of severe allergic reactions, or hypersensitivity, or intolerance to any known component of the investigational products or other monoclonal antibodies\n* Have brain or leptomeningeal metastases with symptoms\n* Presence of clinically symptomatic body cavity effusions (pleural effusion, ascites, pericardial effusion, etc.) requiring local therapy or repeated drainage, or effusions that are poorly controlled per investigator judgment\n* Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases\n* Clinically uncontrolled diseases such as diabetes, thyroid disorders (hormone replacement therapy does not affect enrollment), or other severe systemic diseases requiring systemic treatment\n* Active or progressive infection requiring systemic treatment within 2 weeks before the first dose\n* Known or suspected active autoimmune disease requiring systemic treatment\n* Pregnant or breastfeeding female participants\n* Known history of Hepatitis C or chronic active Hepatitis B",{"count":243,"type":21},120,[24,115],"This open-label, multicenter Phase I\u002FII trial evaluates the combination of FG-M108 and FG-B901 in patients with unresectable locally advanced or metastatic solid tumors that are positive for Claudin 18.2 and have progressed on, are intolerant to, or lack standard therapy. The Phase I dose-escalation part (using a BF-BOIN design) assesses safety, tolerability, and pharmacokinetics, and determines the recommended Phase II dose (RP2D) of FG-B901 when given with fixed-dose FG-M108. The Phase IIa expansion cohorts, grouped by tumor type, further evaluate safety and preliminary efficacy, with antitumor activity measured by RECIST 1.1 and iRECIST, while also exploring biomarker correlates. Key eligibility requires CLDN18.2 positivity (≥10% tumor cells with ≥1+ membrane staining by IHC), ECOG performance status 0-1, and measurable disease. Up to approximately 30 participants will be enrolled per cohort in Phase IIa. The study aims to provide initial evidence on the combination's safety, tolerability, PK, immunogenicity, and clinical activity in this hard-to-treat population.",[247,27],"Claudin 18.2","2026-07-10",{"date":201,"type":37},{"date":230,"type":21},{"date":252,"type":21},"2029-02-28",{"name":254,"class":44},"FutureGen Biopharmaceutical (Beijing) Co., Ltd",{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":22,"phases":264,"briefSummary":265,"conditions":266,"keywords":272,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":279,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":160},"100584961","progress-precision-oncology-using-genomic-reflexive-evaluations-for-study-selection-and-survival-100584961","NCT06896162","PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival","PROGRESS","In order to participate in this study a subject must meet all of the eligibility criteria outlined below.\n\nInclusion Criteria\n\n* Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information.\n* Subjects are willing and able to comply with study procedures based on the judgment of the investigator.\n* Age ≥ 18 years at the time of consent.\n* ECOG or Karnofsky Performance Status of 0-2.\n* Documented Stage IV solid tumor malignancy: NSCLC, CRC, Breast or Bladder Cancer\n* The treating provider deems Next Generation Sequencing (NGS) testing appropriate and plans to consider results in either first- or second-line therapy in the metastatic setting\n* A genomic tumor test has not been ordered or has been ordered but not resulted.\n\nExclusion Criteria:\n\n• Subjects with an active concurrent malignancy.",{"count":263,"type":21},500,[171],"This is a hybrid decentralized, single-arm, interventional study designed to evaluate the impact of precision medicine navigation and reflexive expert review of next-generation sequencing (NGS) for patients with stage IV solid tumor malignancies (breast, lung, colorectal, and bladder cancers).\n\nThe purpose of this study is to investigate whether intervention from a centralized precision oncology navigator and expert review of NGS results by the precision oncology pharmacist will increase ordering of Level 1\u002F2 genome informed therapy (GIT) compared to an estimated historical rate of 15%. Secondary endpoints will assess the impact of a centralized precision oncology navigator and expert review of NGS results on enrollment in biomarker-directed clinical trials and overall survival at 2 years after return of NGS results. The study will take approximately 12 months for enrolment and 2 years of follow-up after the date of NGS results.",[27,267,268,269,270,271],"Metastatic Cancer","Breast Cancer","Colorectal Cancer","Lung Cancer","Bladder Cancer",[273,274,275,276,277,278],"next-generation sequencing (NGS)","expert review of NGS","precision oncology","precision oncology navigator","genome informed therapy (GIT)","biomarker-directed clinical trials",{"date":199,"type":37},{"date":281,"type":37},"2025-06-27",{"date":283,"type":21},"2028-06",{"name":285,"class":185},"UNC Lineberger Comprehensive Cancer Center",{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":22,"phases":295,"briefSummary":297,"conditions":298,"keywords":299,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":160},"100606353","phase-3-trial-to-evaluate-iraes-with-different-standard-of-care-dosing-strategies-of-standard-of-care-immunotherapies-100606353","NCT07174453","Trial to Evaluate irAEs With Different Standard of Care Dosing Strategies of Standard of Care Immunotherapies","A Late Phase Randomized Open-Label Multi Cohort Trial to Evaluate irAEs With Different Standard of Care Dosing Strategies of Standard of Care Immunotherapies","Inclusion Criteria:\n\n1. Ability of participant to understand this study, and participant willingness to sign a written informed consent.\n2. Males and females age ≥ 18 years\n3. ECOG Performance Status (PS) 0 - 2 (Appendix A.)\n4. Females of childbearing potential must have a negative urine pregnancy test 72 hours prior to initiating treatment.\n5. Histologically or cytologically confirmed diagnosis of solid tumor malignancy\n6. Eligible to receive pembrolizumab or nivolumab based therapy\n7. Any disease setting (neoadjuvant, adjuvant, unresectable, metastatic) or any line of therapy is allowed. NOTE: Standard of care combination agents(chemotherapy, targeted therapy, biologics) are allowed because irAEs are the primary objective\n8. Adequate organ function, defined as follows:\n\nLeukocytes (White Blood Cell \\[WBC\\]) \\>1.0 K\u002FUL Absolute Neutrophil Count \\>1.0 K\u002FUL Platelets \\> 50 K\u002FUL Hemoglobin ≥ 7 g\u002FdL Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL\u002Fmin using the Cockcroft-Gault equation Total bilirubin ≤ 1.5 x ULN Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN\n\nExclusion Criteria:\n\n1. Simultaneously enrolled in any therapeutic clinical trial\n2. Concurrent or planned use of other immunotherapies or radiation\n3. Has not recovered from irAEs due to prior immunotherapy treatment (\\>=grade 2 is considered not recovered). Conditions that meet grade 2 criteria but are considered clinically stable at the discretion of the investigator will be allowed.\n4. Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements\n5. Currently pregnant or breastfeeding\n6. Has a known allergic reaction to any excipient contained in the study drug formulation\n7. Active Grade 3 (per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 ) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment.",{"count":294,"type":21},192,[296],"PHASE3","Phase 3\u002F4 open label, randomized two cohort study (2 arms in each cohort).\n\nIt is hypothesized that for people with a histologically or cytologically confirmed diagnosis of malignancy, the higher dose immunotherapy (every 6 weeks Pembrolizumab 400mg dose and every 4 weeks Nivolumab 480mg dose) has more immune-related adverse events irAEs compared to lower dose (every 3 weeks Pembrolizumab 200mg dose and every 2 weeks Nivolumab 240mg dose).",[27],[300],"Immunotherapy","2026-06-29",{"date":303,"type":37},"2026-07-01",{"date":305,"type":37},"2025-10-07",{"date":307,"type":21},"2029-10-01",{"name":309,"class":185},"University of Kansas Medical Center",{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":22,"phases":319,"briefSummary":320,"conditions":321,"keywords":332,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":160},"100644129","phase-1-imaging-study-of-89zrdfo-ys5-for-cancer-detection-100644129","NCT07664397","Imaging Study of [89Zr]DFO-YS5 for Cancer Detection","A Pilot PET Imaging Study of [89Zr]DFO-YS5 for Detection of Cancer in Patients With Various Malignancies","Inclusion Criteria:\n\n1. Histological or cytological confirmation of malignant peripheral nerve sheath tumor, bladder cancer, or solid tumor neoplasm.\n2. At least one soft tissue lesion measurable at 1 cm or greater in short axis measurement on cross sectional imaging such as Computerized tomography (CT), magnetic resonance imaging (MRI), or Positron Emission Tomography (PET)\u002FCT (scan imaging as documented in the medical record). Exception: For participants with localized bladder cancer (pre-cystectomy), lesions smaller than 1 centimeter (cm) are permitted, provided there is cystoscopic confirmation of a bladder mass.\n3. Clinically able to undergo PET-CT imaging or PET-MRI.\n4. Age ≥ 18 years.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky ≥ 50% (see Appendix 1).\n6. Adequate organ function as defined below:\n\n   * Total bilirubin: ≤ 1.5 x institutional upper limit of normal (ULN) (unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits).\n   * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)): ≤ 3 x ULN.\n   * Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)): ≤ 3 x ULN.\n   * Estimated creatinine clearance: ≥ 60 mL\u002Fmin, calculated using the Cockcroft-Gault equation.\n7. Females of reproductive potential (defined below) must be willing to undergo a urine or serum pregnancy test (i.e., human chorionic gonadotropin test) within 72 hours before administration of \\[89Zr\\]DFO-YS5. A female is considered to NOT be of reproductive potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and\u002For bilateral oophorectomy for removal of uterus and\u002For ovaries). The result of the urine or serum pregnancy test must be negative in order to initiate the \\[89Zr\\]DFO-YS5 administration. If a urine pregnancy test is positive or equivocal, a confirmatory a serum pregnancy test is required. The individual must be excluded from participation if the serum pregnancy result is positive. Pregnant individuals are excluded from this study because there is an unknown but potential risk for adverse effects in the unborn child secondary to treatment of the study participant with \\[89Zr\\]DFO-YS5.\n8. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or endpoints of this study are eligible.\n9. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Individuals with a contraindication to PET-CT imaging (e.g., severe claustrophobia) or PET-MRI (e.g., implanted devices, metallic objects, or other implants). Participants must be able to undergo either PET-CT or PET-MRI.\n2. Individuals who are pregnant or breastfeeding\u002Fchest-feeding. Pregnant and breastfeeding\u002Fchest-feeding individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn\u002Fnursing child secondary to treatment of the study participant with \\[89Zr\\]DFO-YS5. Females of childbearing potential must have a negative pregnancy test before administration of \\[89Zr\\]DFO-YS5, as outlined in inclusion criterion #7. Breastfeeding\u002Fchest-feeding should be discontinued before administration of \\[89Zr\\]DFO-YS5.\n3. Individuals who do not agree to follow the below contraception requirements:\n\n   Females of reproductive potential (defined below) must agree to use two forms of contraception, consisting of a barrier method (such as condoms) in combination with a secondary complementary method (such as hormonal, Intrauterine device (IUD), etc.), or strict abstinence, for the duration of study participation and for 1 month after administration of \\[89Zr\\]DFO-YS5. A female is considered to NOT be of reproductive potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and\u002For bilateral oophorectomy for removal of uterus and\u002For ovaries).\n4. Hypersensitivity to \\[89Zr\\]DFO-YS5 or any of its excipients.\n5. Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study procedures.",{"count":318,"type":21},40,[24],"This is a single-center, pilot, PET-imaging study of the novel radiotracer 89Zirconium-89 DFO conjugated to the YS5 monoclonal antibody (\\[89Zr\\]DFO-YS5) in participants with nerve sheath tumor, bladder cancer, or advanced solid tumor neoplasms.",[271,322,323,27,324,325,326,327,328,329,330,331],"Nerve Sheath Tumor","Nerve Sheath Tumors","Solid Tumor Cancer","Solid Tumor Neoplasms","Advanced Solid Tumor","Bladder Neoplasm","Nerve Sheath Neoplasms","Nerve Sheath Tumor, Nos","Solid Tumor, Adult","Solid Carcinoma",[333],"Imaging Study","2026-06-17",{"date":336,"type":37},"2026-06-24",{"date":338,"type":21},"2026-08-01",{"date":340,"type":21},"2029-09-30",{"name":342,"class":185},"Robert Flavell, MD, PhD",{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":22,"phases":351,"briefSummary":352,"conditions":353,"keywords":357,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":160},"100624280","phase-1-ph-iii-sodium-thiosulfate-for-otoprotection-during-cisplatin-stop-cis-100624280","NCT07407582","Ph. I\u002FII Sodium Thiosulfate for OtoProtection During Cisplatin (STOP-CIS)","Phase I\u002FII Open Label Trial of Intravenous Sodium Thiosulfate (Pedmark®) as Otoprotectant in Adults Receiving Cisplatin Chemotherapy (STOP-CIS)","Inclusion Criteria:\n\n* Participants have provided informed consent prior to initiation of any study-specific activities.\n* At least 18 years of age, male or female, at the time of signing the informed consent.\n* ECOG Performance Status 0-1\n* Histologically or cytologically confirmed treatment-naïve cancer.\n* Scheduled to receive an FDA-approved, on-label indication, standard of care systemic cisplatin-based regimen (at least 200 mg\u002Fm2 cumulative dose) for any untreated any solid malignancy deemed by the treating physician\n\nExclusion Criteria:\n\n* Prior cisplatin exposure due to a cancer treatment history\n* Concurrent ototoxic medication unable to be safely discontinued or switched to a non-toxic alternative\n* Planned radiation to the head or neck prior to, during, or within 3 months of completion of cisplatin\n* History of severe hypersensitivity to sulfite, sodium thiosulfate, or any components\n* Baseline serum sodium \\> 145 mmol\u002FL or any grade ≥ 3 electrolyte abnormality\n* Cisplatin infusion duration greater than 6 hours\n* Females during pregnancy or breastfeeding, and childbearing potential, unwilling to use a method of contraception during treatment\n* Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment\n* Subject likely not to be available to complete all protocol-required study visits or procedures, and\u002For to comply with all required study procedures (i.e., Clinical Outcome Assessments) to the best of the subject's and investigator's knowledge.\n* History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.",{"count":7,"type":21},[24,115],"The purpose of this study is to assess the safety and effectiveness of a drug called Pedmark® sodium thiosulfate (STS) in reducing hearing impairment with standard of care cisplatin therapy. The safety and effectiveness of STS in reducing hearing loss has been well established in children and is approved for use in the pediatric and young adult population. However, information in adult patients is limited. As most cisplatin is administered in the adult population, this investigation would be of benefit.",[27,354,355,356],"Testicular Cancer","Head and Neck Cancer","Thoracic Cancer",[358,359,360,361,362,363,223],"Cisplatin","Otoprotectant","Cancer","Hearing Impairment","Sodium Thiosulfate","Adults","2026-06-16",{"date":366,"type":37},"2026-06-18",{"date":368,"type":37},"2026-05-18",{"date":370,"type":21},"2028-04-30",{"name":372,"class":185},"University of Arizona",{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":22,"phases":382,"briefSummary":383,"conditions":384,"keywords":385,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":396},"100608911","phase-1-a-study-to-investigate-the-safety-and-efficacy-of-kqb548-in-participants-with-advanced-solid-malignancies-100608911","NCT07207707","A Study to Investigate the Safety and Efficacy of KQB548 in Participants With Advanced Solid Malignancies","A Phase 1a, Open-label, Multicenter, Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB548 in Participants With Advanced Solid Malignancies With a KRAS G12D Mutation","Inclusion Criteria:\n\n* Pathologically confirmed, locally advanced or metastatic PDAC, CRC, or NSCLC with a KRAS G12D mutation\n* Progressed on, or intolerant to at least one prior line of systemic standard of care therapy\n* Measurable disease according to RECIST v1.1\n* Adequate organ function\n\nExclusion Criteria:\n\n* Previous treatment with a KRAS G12D inhibitor or pan-RAS inhibitor\n* History of intestinal disease, uncontrolled inflammatory bowel disease (e.g., Crohn's disease, Ulcerative Colitis), major esophageal or gastric surgery, or other gastrointestinal conditions (e.g., uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study intervention or result in inability to swallow oral medications\n* Poorly controlled ascites and\u002For pleural effusion\n* Requires treatment with a strong and\u002For moderate CYP3A inhibitor or inducer\n* Requires treatment with a proton-pump inhibitor",{"count":381,"type":21},78,[24],"The goal of this trial is to learn if KQB548 works to treat patients with advanced solid malignancies with a KRAS G12D mutation. It will also learn about the safety of KQB548. The main questions it aims to answer are:\n\n* What is the safe dose of KQB548?\n* Does KQB548 decrease the size of the tumor?\n* What happens to KQB548 in the body?",[27],[386,387],"KRAS","G12D",{"date":389,"type":37},"2026-05-20",{"date":391,"type":37},"2025-09-16",{"date":393,"type":21},"2027-03",{"name":395,"class":44},"Kumquat Biosciences Inc.",13,{"id":398,"slug":399,"hasResults":12,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":4,"eligibilityCriteria":403,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":404,"targetDuration":4,"studyType":22,"phases":406,"briefSummary":407,"conditions":408,"keywords":415,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":78},"100605812","xdrive-for-florida-based-cancer-patients-100605812","NCT07167381","xDRIVE for Florida-based Cancer Patients","xDRIVE Functional Precision Medicine + Artificial Intelligence Individualized Treatments for Florida-based Cancer Patients With Relapsed\u002F Refractory Cancers","Inclusion Criteria:\n\n* Patients with recurrent\u002Frefractory cancer patients up to age 18 (willing to sign assent if ages 7 - 17 years)\n* -OR- Patients with recurrent\u002Frefractory cancer ≥18 years of age.\n* Patients who have received at least one prior line of standard of care therapy.\n* Patients able to provide treatment and outcome information from previous line(s) of therapy.\n* Patients with sufficient health status to undergo cancer therapy, e.g., Eastern Cooperative Group (ECOG) performance status of 0, 1, or 2 for adult patients.\n* Patients who are scheduled for or have recently undergone a tumor biopsy, excision, or resection.\n* Patients willing to have a blood draw or buccal swab performed for matched normal material for comparison during tumor DNA profiling.\n\nExclusion Criteria:\n\n* Patients who do not have malignant tissue available and accessible, patients where the amount of excised malignant tissue is insufficient material for ex vivo drug testing and\u002For genetic profiling, defined as \\\u003C0.3g for resections or core\u002Ffine-needle biopsies not containing malignant tissue by pathology review, or insufficient malignant tissue in peripheral blood or bone marrow aspirate samples.\n* Patients with insufficient health indicators to undergo therapeutic intervention.",{"count":405,"type":21},210,[171],"Through this study funded by the Florida Cancer Innovation Fund, First Ascent will demonstrate state-wide feasibility of providing xDRIVE Functional Precision Medicine + Artificial Intelligence platform by assessing patient clinical benefit and health economics impacts. As this is a feasibility study, results will be returned to the physician and the physician may use the data to inform the next line of treatment. The investigator will run a prospective single-arm feasibility study providing the xDRIVE FPM AI platform to n = 210+ cancer patients throughout the state of Florida, especially those from underserved populations (pediatric patients and patients in Black, Brown, Hispanic, and rural communities).",[360,409,410,411,412,413,27,414],"Neoplams","Refractory","Recurrence","Leukaemia","Lymphoma","Solid Cancers",[416,417],"Functional Precision Medicine","Artificial Intelligence","2026-05-17",{"date":420,"type":37},"2026-05-19",{"date":422,"type":37},"2025-11-01",{"date":424,"type":21},"2027-04-01",{"name":426,"class":44},"First Ascent Biomedical Inc.",{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":4,"eligibilityCriteria":433,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":22,"phases":436,"briefSummary":437,"conditions":438,"keywords":442,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":454},"100571494","phase-1-a-study-to-investigate-the-safety-and-efficacy-of-kqb365-as-monotherapy-and-in-combination-in-participants-with-advanced-solid-malignancies-100571494","NCT06720987","A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies","A Phase 1\u002F1b, Open-label, Multicenter, Dose Escalation and Dose Optimization Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB365 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies With KRAS G12S or G12C Mutations","Inclusion Criteria:\n\n* PART 1 (monotherapy and combo therapy with KQB198): Histologically confirmed diagnosis of a solid tumor malignancy with either a KRAS G12C or KRAS G12S mutation.\n* PART 1 (combo therapy with Cetuximab) \\& PART 2: Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum with either a KRAS G12C or KRAS G12S mutation.\n* Unresectable or metastatic disease\n* No available treatment with curative intent\n* Adequate organ function\n* Measurable disease per RECIST v1.1\n\nExclusion Criteria:\n\n* Active primary central nervous system tumors\n* Cardiac abnormalities\n* Active interstitial lung disease\n* Unable to swallow or GI condition that prevents absorption for patients in KQB198 combination cohorts",{"count":435,"type":21},140,[24],"The goal of this clinical trial is to learn if KQB365 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB365. The main questions it aims to answer are:\n\n* What is the safe dose of KQB365 by itself, in combination with cetuximab, or in combination with KQB198?\n* Does KQB365 alone, in combination with cetuximab, or in combination with KQB198 decrease the size of the tumor?\n* What happens to KQB365 in the body?\n\nParticipants will:\n\n* Receive KQB365 infusion weekly alone, in combination with cetuximab, or in combination with oral KQB198.\n* Visit the clinic about 9 times in the first 6 weeks, and then once every week after that.",[439,440,27,441],"KRAS G12C Mutation","KRAS G12S Mutation","CRC (Colorectal Cancer)",[443,444,445],"cetuximab","KQB365","KQB198","2026-04-20",{"date":448,"type":37},"2026-04-23",{"date":450,"type":37},"2025-02-04",{"date":452,"type":21},"2030-06-30",{"name":395,"class":44},11,{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":22,"phases":465,"briefSummary":466,"conditions":467,"keywords":470,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":484},"100616267","phase-2-efficacy-and-safety-of-the-valemetostat-in-patients-with-selected-solid-tumors-100616267","NCT07303387","Efficacy and Safety of the Valemetostat in Patients With Selected Solid Tumors.","An Open Label Phase II Platform Modular Study Exploring the Efficacy and Safety of the Valemetostat (EZH1\u002F2 Inhibitor) in Patients With Selected Solid Tumors","EZHiSWITCH","Inclusion Criteria:\n\n1. Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed.\n2. Ability to comply with the protocol.\n3. Age ≥ 18 years.\n4. Patients must have histologically or cytologically confirmed progressive metastatic or recurrent solid tumor (as defined below for each tumor type). Diagnosis must be stated in a pathology report and confirmed by the investigator.\n5. Evidence of disease progression prior to trial entry.\n6. Have exhausted all other standard-of-care therapeutic options which have shown efficacy in their disease and are expected to be more effective than valemetostat based on current evidence for standard-of-care and EZH1\u002F2 inhibitors\n7. Have an archival tissue sample available with sufficient tumor tissue for IHC confirmation of loss expression (20 slides required). If patients do not have sufficient archival material, a new biopsy should be scheduled.\n8. Have documented bi-allelic (homozygous) deletion of SMARCB1, SMARCA4\u002F2, ARID1A\u002FB, PBRM1, BAP1, SMARCC1\u002F2 or other SWI\u002FSNF in a tumor detected by a validated NGS test (solid or liquid) and confirmed loss of expression in tumour cells by centralized IHC.\n\n   Cohort 1.A - SMARCB1-defective (maximum of 1 prior treatment line) Cohort 1.B - SMARCA4 (maximum of 3 prior treatment lines) Cohort 1.C - ARID1A (maximum of 2 prior treatment lines) Cohort 1Ca: Endometrial and ovarian clear cell only Cohort 1Cb: Other ARID1A-defective tumors Cohort 1.D - PBRM1 (with a minimum of 6 clear cell renal cell carcinoma during stage 1; maximum of 3 prior treatment lines) Cohort 1.E - BAP1 (with a maximum of 5 mesothelioma during stage 1; maximum of 2 prior treatment lines) Cohort 1.F - SMARCA2 or other SWI\u002FSNF subunits (maximum of 2 prior treatment lines) Cohort 1.G - Clear cell Endometrial or Ovarian carcinoma SWI\u002FSNF wild-type (maximum of 2 prior treatment lines) Tissue used for assessing SWI\u002FSNF or BAP1 status must be \\\u003C 3 years old; otherwise, a new fresh biopsy should be performed.\n9. At least one lesion, not previously irradiated, measurable according to RECIST v1.1 (PCWG3\u002FRECIST1.1 for prostate cancer and mRECIST for pleural mesothelioma) as ≥10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and suitable for repeated assessment.\n10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration at the time of enrollment.\n11. Estimated life expectancy of greater than 12 weeks.\n12. Adequate hematologic and organ function, defined by the following laboratory results obtained within 3 days prior to the first study treatment (Cycle 1 Day 1):\n\n    1. Absolute neutrophil count (ANC) ≥ 1500 cells\u002FμL (without granulocyte colony-stimulating factor support within 14 days prior to the screening assessment).\n    2. Lymphocyte count ≥ 500\u002FμL.\n    3. Platelet count ≥ 100.000\u002FμL (platelet transfusion is not allowed within 14 days prior to the screening assessment).\n    4. Hemoglobin ≥ 9g\u002FdL (packed red blood cell transfusion is not allowed within 14 days prior to the screening assessment).\n    5. Total bilirubin ≤ 1.5 ULN (subjects with documented\u002Fsuspected Gilbert's disease can have total bilirubin ≤3x ULN and direct bilirubin ≤1.5x ULN or subjects with liver metastases at baseline can have total bilirubin ≤ 3 × ULN).\n    6. Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) ≤ 3.0x upper normal limit (ULN) or ≤ 5 × ULN in case of liver metastases.\n    7. Albumin ≥ 2.5g\u002FdL.\n    8. Creatinine clearance ≥ 40 mL\u002Fmin (according to Cockroft and Gault formula).\n    9. International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN. This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular weight heparin or warfarin) should be on stable dose and must have PT-INR within therapeutic range as deemed appropriate by the Investigator.\n13. Women of childbearing potential must have at least one negative serum β-HCG pregnancy test during the screening assessment. Prior to the administration of the first study treatment, there must be a negative serum β-HCG pregnancy test within 72 hours prior or a negative urine pregnancy test within 24 hours prior. Women of childbearing potential must have a negative serum pregnancy test at Screening and must be willing to use highly effective birth control, upon enrollment, during the Treatment Period, and for 3 months, following the last dose of study drug administration.\n\n    A woman is considered of childbearing potential following menarche and until becoming post-menopausal (≥ 12 months of non-therapy-induced amenorrhea) unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral oophorectomy and bilateral salpingectomy with surgery at least 1 month before the first dose of study drug or confirmed by follicle stimulating hormone (FSH) test \\>40 mIU\u002FmL and estradiol \\\u003C40 pg\u002FmL (\\\u003C140 pmol\u002FL).\n14. Sexually active women of childbearing potential must agree to use a highly effective method of contraception \\\u003C\\\u003C supplemented by a barrier method \\>\\>, or to abstain from sexual activity during the study and for at least 3 months after the last dose of study treatment.\n15. Participant must agree to not breastfeed during the study or for 3 months after the last dose of study treatment.\n16. Sexually active male's patients with partner of childbearing potential, the subject must be surgically sterile or willing to use highly effective birth control upon enrollment, during the Treatment Period, and for 3 months following the last dose of study drug.\n17. Participant must agree to not donate blood during the study or for 3 months days after the last dose of study treatment.\n18. Male subjects must not freeze or donate sperm starting at Screening and throughout the study period, and for at least 3 months after the final study drug administration.\n19. Female subjects must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 3 months after the final study drug administration.\n20. Patient should be able and willing to comply with study visits and procedures as per protocol.\n21. Patients must be affiliated to a social security system or beneficiary of an equivalent system.\n\nExclusion Criteria:\n\n1. Participation in another clinical study with an investigational product during the last 4 weeks (excepting observational or non-interventional clinical studies).\n2. Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) 21 days prior to the first dose of study drug, or five half-lives of the previous agent, whichever is the longer.\n3. Participant has had radiation therapy encompassing \\>20% of the bone marrow within 2 weeks prior to Cycle 1 Day 1; or curative radiation therapy or major surgery within 4 weeks or palliative radiation therapy within 2 weeks prior to Cycle 1 Day 1.\n4. History of another primary malignancy within 5 years prior to Cycle 1 Day 1 except for:\n\n   1. Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study drug and of low potential risk for recurrence.\n   2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n   3. Adequately treated carcinoma in situ without evidence of disease (eg, carcinoma in situ of the cervix, ductal carcinoma in situ treated surgically with curative intent).\n5. Treatment with systemic (\\>10 mg daily prednisone equivalents). or other immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor agents) within 2 weeks prior to Cycle 1 Day 1, or anticipated requirements for systemic immunosuppressive medications during the trial:\n\n   The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids for patients with orthostatic hypotension, low-dose supplemental corticosteroids for adrenocortical insufficiency and topical steroids for cutaneous diseases are allowed.\n6. Acute toxicities from previous therapies that have not resolved to Grade ≤ 1, with the exception of alopecia.\n7. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins. Known or suspected hypersensitivity to valemetostat tosylate or any of the excipients.\n8. Uncontrolled or significant cardiovascular disease, including the following:\n\n   1. Evidence of prolongation of QT\u002FQTc interval (eg, repeated episodes of QT corrected for heart rate using Fridericia's method \\[QTcF\\] \\>470 ms) (average of triplicate determinations) refer to APPENDIX 9.\n   2. Myocardial infarction within 6 months prior to Screening.\n   3. Uncontrolled angina pectoris within 6 months prior to Screening.\n   4. New York Heart Association (NYHA) Class 3 or 4 congestive heart failure.\n   5. Uncontrolled hypertension (resting systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg).\n   6. Patients with known left ventricular ejection fraction (LVEF) \\\u003C 40%; patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or LVEF \\\u003C 50% must be on a stable cardiologic treatment.\n9. Known positive test for HIV or known acquired immunodeficiency syndrome\n10. Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection within 28 days prior to the first dose of study drug (hepatitis B surface antigen positive or have detectable HBV DNA or detectable HCV RNA).\n11. Active tuberculosis.\n12. Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection requiring treatment with intravenous antibiotics, antivirals, or antifungals. Note: Subjects with localized fungal infections of skin or nails are eligible.\n13. Any active uncontrolled systemic diseases or other medical conditions considered to be poorly controlled by the investigator, including, but not limited to, bleeding diatheses\n14. Current use of moderate or strong cytochrome P450 (CYP)3A inducers (Table 8)\n15. Administration of attenuated or live vaccine within 4 weeks prior to Cycle 1 Day 1 or anticipation that such a live attenuated vaccine will be required during the study (except anti-COVID-19 vaccines).\n16. Major surgical procedure within 20 days prior ty Cycle 1 Day 1 or anticipation of need for a major surgical procedure during the course of the study.\n17. Uncontrolled tumor-related pain: patients requiring pain medication must be on a stable regimen at study entry and symptomatic lesions amenable to palliative radiotherapy should be treated prior to enrolment.\n18. Uncontrolled effusion (pleural, pericardial or ascites) requiring recurrent drainage procedures (once a month or more frequently); patients with indwelling catheters (e.g. PleurX) are allowed.\n19. Uncontrolled hypercalcemia (\\>1.5mmol\u002FL ionized calcium or Ca \\> 12mg\u002FdL or corrected serum calcium \\>ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab.\n20. History of leptomeningeal disease\n21. Symptomatic CNS metastasis or uncontrolled CNS metastasis, requiring increasing doses of steroids or stable dose of steroids \\> 10mg prednisone QD.\n22. Spinal cord compression without evidence that disease has been clinically stable for ≥ 2 weeks prior to Cycle 1 Day 1.\n23. Female subjects who are pregnant, breast-feeding or male \u002F female patients of reproductive potential who are not employing an effective method of birth control.\n24. Previous treatment with EZH2 (or EZH1\u002F2) inhibitors, except for cohort 1A where EZH2 inhibitors are approved.\n25. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study result.\n26. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.",{"count":464,"type":21},900,[115],"Rational, objective and design: Some cancer-protecting genes are inactivated when the EZH2 enzyme is too active or the SWI\u002FSNF complex is less active. The EZH1\u002F2 enzymes and the SWI\u002FSNFs complex play opposing roles in gene expression: we hypothesize that valemetostat, an inhibitor of the EZH1\u002F2 enzymes, will stop\u002Fslow down the growth of cancer cells by reactivating these genes. Numerous clinical trials are currently underway worldwide to optimize the development of valemetostat tosylate and potentially offer a new targeted therapeutic option for patients suffering from various cancer pathologies.\n\nThe aim of this research is to evaluate the efficacy of valemetostat on solid tumors, which have an alteration in certain genes: SMARC (B1\u002FA4\u002FA2\u002FC1\u002FC2), ARID (1A\u002F1B), PBRM1, BAP1 and other SWI\u002FSNF sub-units. The research will be conducted in two phases: 1) Pre-selection of patients with the desired alterations. 2) Treatment with valemetostat, 200mg\u002Fday, for a maximum of 2 years, with examinations every 28 days.\n\nThis is a multicenter, international, phase II open-label, multicenter modular study exploring the efficacy and safety of valemetostat. Module 1 will be the SWI\u002FSNF basket monotherapy study describe below. Such design will allow the study to evolve considering signals for further monotherapy and\u002For combination modules.\n\nThe Primary endpoint of the study is Overall Response Rate at 24 weeks, defined as the proportion of patients with a confirmed best overall response.\n\nTrial population: Adult patients with histologically\u002Fcytologically confirmed progressive metastatic or recurrent solid tumor, who have selected chromatin remodeling deficiency in at least one of the following genes: SMARCB1, SMARCA4, SMARCA2, SMARCC1, SMARCC2, ARID1A, ARID1B, PBRM1, BAP1and other SWI\u002FSNF sub-units; or molecularly (Wildtype) and phenotypically-selected Clear cell endometrial or ovarian carcinoma cancers. Patients must be using an effective method of contraception and have signed the consent form. They must not participate in another clinical study with an investigational product during the last 3 weeks, during the study treatment and not have a contraindication to the study treatment (…) Intervention: After confirmation by IHC of the loss of expression in tumors cells of SMARCB1, SMARCA4, SMARCA2, SMARCC1, SMARCC2, ARID1A, ARID1B, PBRM1, BAP1and other SWI\u002FSNF sub-units and validation of inclusion\u002Fexclusion criteria patients will included in different cohorts (refer to investigation scheme). All patients will receive Valemetostat (200 mg per day), divided into 28-day periods called treatment cycles, for a maximum of two years. The main interventions scheduled are blood samples (to evaluate biological parameters and for translational research), electrocardiogram, echocardiography and CTscan. For patients who have consented, sequential biopsies will be performed as follow: at baseline, on treatment and at progression.\n\nEthical consideration: This research will make it possible to collectively evaluate the interest of EZH1\u002F2 inhibitor in solids tumors with SWI\u002FSNF defect. Individually, by participating in this research, patients could benefit from these treatments based on cell-based results and in the treatment of relapsed\u002Frefractory peripheral T-cell lymphomas, with an improvement in symptoms and quality of life. As with any research, the investigational drug and other procedures that take place may involve risks, some of which are already known and others not yet described. The main risks (described in the consent form) are side effects of the valemetostat. If they agree, patients will also be monitored more closely with their safety assessed through patient-reported outcomes (PRO), the evaluation of their experience through qualitative interviews \\& assessment of quality of care and the evaluation of their biometric physiological via a wearable device.",[27,468,469],"Clear Cell Endometrial Carcinoma","Ovarian Cancer",[471,472,473,474],"solid tumor","chromatin remodeling deficiency","Valemetostat","EZH1\u002F2 inhibitor","2026-04-16",{"date":477,"type":37},"2026-04-21",{"date":479,"type":37},"2026-03-05",{"date":481,"type":21},"2032-02-28",{"name":483,"class":185},"Gustave Roussy, Cancer Campus, Grand Paris",4,{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":22,"phases":494,"briefSummary":495,"conditions":496,"keywords":499,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":484},"100589898","phase-1-safety-and-preliminary-efficacy-of-vir-5525-and-vir-5525--pembrolizumab-in-participants-with-locally-advanced-or-metastatic-solid-tumors-100589898","NCT06960395","Safety and Preliminary Efficacy of VIR-5525 and VIR-5525 + Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors","A Phase 1, First-in-Human Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5525 Alone and in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\nI 01. Are ≥ 18 years of age, or at the country's legal age of majority of the legal adult age is \\>18 years, at the time of signing the ICF.\n\nI 02. Have an ECOG performance status of 0 to 1.\n\nI 03. Have a life expectancy of at least 12 weeks.\n\nI 04. Have histological, pathological, or cytological confirmation of disease type that is unresectable, locally advanced, or metastatic.\n\nI 05. Have measurable disease per RECIST v1.1 as assessed by the local site investigator\u002Fradiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n\nI 06. Have diseases under study, lines of therapy, and biomarker status, as follows:\n\nHave one of the following:\n\n• (Parts 1 and 3): NSCLC (nonsquamous or squamous histology), CRC, HNSCC, or CSCC.\n\nNote: Participants with nasopharyngeal tumors are eligible. Note: Participants with upper esophageal or salivary gland tumors are not eligible.\n\nOR\n\n• Have a solid tumor with EGFR amplification (as previously determined locally with an analytically validated assay in a certified testing laboratory).\n\nHave no available standard systemic therapy; or standard therapy is intolerable, not effective, or not accessible; or participant has refused standard therapy.\n\nExclusion Criteria:\n\nE 01. Are a WOCBP with a positive serum or urine pregnancy test within 72 hours prior to treatment.\n\nE 02. Have acute or chronic infections, including the following:\n\n* Acute or chronic active Epstein-Barr virus (EBV) infection (Exception: asymptomatic EBV-positive participants are still eligible)\n* Chronic active EBV disease defined as a chronic illness lasting at least 6 months, an increased EBV level in either the tissue or the blood, and lack of evidence of a known underlying immunodeficiency\n* History of hepatitis B infection (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or known active hepatitis C virus (HCV) infection (defined as HCV \\[HCV RNA; qualitative\\] is detected)\n* History of HIV infection. No HIV testing is required unless mandated by the local health authority.\n* Active infection requiring systemic therapy within 14 days of Cycle 1 Day 1\n* Known positive COVID-19 test result at screening (Exception: If follow-up test is negative, participants may be eligible if asymptomatic and upon consultation with medical monitor)\n\nE 03. Have a concomitant medical or inflammatory condition that may increase the risk of toxicity to VIR-5525 or pembrolizumab, per the investigator\n\nE 04. Have a QT interval corrected by Fridericia's method (QTcF) that is \\>480 ms\n\nE 05. Have received prior systemic anti-cancer therapy, including investigational agents, within 5 half-lives prior to first dose of study intervention. For drugs with a long t1\u002F2, such as mAbs, or for drugs for which the t1\u002F2 is not known, the last dose should not have been within 28 days prior to first dose of study intervention.\n\nNote: If the participant has had major surgery, the participant must have recovered adequately from the procedure and\u002For any complications from the surgery prior to starting study intervention.\n\nE 06. Have received prior radiotherapy within 2 weeks of start of study intervention Note: Participants must have recovered from all radiation-related toxicities to Grade ≤1 or baseline, must not require corticosteroids, and must not have had radiation pneumonitis.\n\nException: External beam radiotherapy, including palliative external radiation, is allowed.\n\nA 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n\nThe above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.",{"count":493,"type":21},450,[24],"This Phase 1, first-in-human (FIH), dose-escalation and dose-expansion study is designed to evaluate the safety, PK, and preliminary anti-tumor activity of VIR-5525 as a monotherapy and in combination with pembrolizumab in participants with solid tumors that are known to express EGFR.\n\nThe study will be conducted in the following 4 parts:\n\n* Part 1: VIR-5525 monotherapy dose escalation\n* Part 2: VIR-5525 monotherapy dose expansion\n* Part 3: VIR-5525 plus pembrolizumab dose escalation\n* Part 4: VIR-5525 plus pembrolizumab dose expansion",[27,497,498],"EGFR Positive Solid Tumors","EGFR",[500],"VIR-5525","2026-04-10",{"date":503,"type":37},"2026-04-13",{"date":505,"type":37},"2025-07-22",{"date":507,"type":21},"2029-08",{"name":509,"class":44},"Vir Biotechnology, Inc.",{"id":511,"slug":512,"hasResults":12,"nctId":513,"briefTitle":514,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":516,"targetDuration":111,"studyType":518,"phases":4,"briefSummary":519,"conditions":520,"keywords":521,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":4},"100629581","exploration-study-of-molecular-biomarkers-for-tumor-related-anxiety-and-depression-100629581","NCT07476534","Exploration Study of Molecular Biomarkers for Tumor-related Anxiety and Depression","Inclusion Criteria:\n\n1. Patients with solid tumors aged ≥18 years and an expected survival period of ≥3 months;\n2. Patients who meet clinical diagnostic criteria and are pathologically\u002Fhistologically confirmed as having solid tumors, including liver cancer patients (diagnosable by imaging);\n3. Patients who can complete standardized stratified assessments for tumor-related anxiety and depression, and are able to cooperate with researchers in completing psychological scales such as the Self-Rating Anxiety Scale (SAS) and the Self-Rating Depression Scale (SDS). They have not received any anti-anxiety\u002Fdepression medications, professional psychological counseling, or psychiatric interventions before scale assessment;\n4. Patients with clear consciousness, normal language communication, comprehension, and cognitive abilities, without a history of psychiatric disorders, and who can independently provide feedback on research-related information and cooperate with follow-up;\n5. Patients who voluntarily participate in the study, fully understand the research objectives, procedures, potential risks, and benefits, and have signed a written informed consent form;\n6. Patients who can cooperate in completing the required laboratory tests (complete blood count, blood biochemistry, coagulation function, etc.) and clinical data collection before and during the perioperative period to ensure the completeness of research data.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. Patients aged \\\u003C21 years at first visit and with an expected survival period of \\\u003C3 months;\n3. Patients who have previously received anti-anxiety\u002Fdepression medications or professional psychological interventions;\n4. Patients with a history or current diagnosis of psychiatric disorders, including schizophrenia, bipolar disorder, severe cognitive dysfunction, mental retardation, or those who cannot cooperate with SAS\u002FSDS scale assessment or have contraindications to scale evaluation;\n5. Patients with severe organ dysfunction or severe underlying diseases, including: liver failure (Child-Pugh C grade), renal failure (serum creatinine \\>250 μmol\u002FL or \\>2.83 mg\u002FdL), New York Heart Association (NYHA) Class IV heart failure, active pulmonary tuberculosis, HIV infection, etc. (to be determined);\n6. Patients with contraindications to tumor tissue or blood sample collection, including coagulation disorders (INR \\>1.5, platelets \\\u003C50×10⁹\u002FL), severe bleeding tendency, or surgical specimens that cannot meet detection requirements (e.g., \\>50% necrotic tissue, insufficient tissue amount);\n7. Patients with emotional abnormalities due to non-tumor factors, including hyperthyroidism\u002Fhypothyroidism, severe malnutrition, chronic wasting diseases, or psychological stress disorders;\n8. Patients who have undergone non-tumor-related surgical procedures, enteral\u002Fparenteral nutrition support within the past 1 month, or have clinical symptoms such as gastrointestinal mechanical obstruction, intractable vomiting, ascites, significant edema, or large pleural effusion;\n9. Patients who are planned or currently using medications that may affect emotional assessment or protein expression detection during the study, including: long-term oral corticosteroids, 5-HT receptor agonists\u002Fantagonists (SSRIs, etc., even short-term use within 2 weeks before sampling is excluded), antipsychotic drugs, or gestagenic synthetic steroid derivatives (short-term inhaled\u002Flocal use of steroids or intermittent use of inhaled bronchodilators are excluded);\n10. Patients with incomplete clinical data, inability to cooperate with research-related follow-up and testing, or those who refuse to sign the informed consent form or have poor compliance.",{"count":517,"type":21},100,"OBSERVATIONAL","Identifying and validating molecular biomarkers associated with tumor-related anxiety and depression. By integrating psychological assessment data from clinical tumor patients with molecular detection results, and utilizing clinically accessible samples such as tumor tissues and sera from clinical cohorts, this study aims to clinically validate the tumor-derived proteins previously identified by our team as having potential regulatory roles. The goal is to clarify the clinical value of tumor-derived proteins as molecular biomarkers for tumor-related anxiety and depression, providing a molecular basis for early screening and risk stratification. Alternatively, it seeks to establish a tumor-related anxiety and depression risk assessment model based on the expression levels of tumor-derived proteins, offering a reference for the precise identification and targeted intervention of psychological disorders in tumor patients.",[27],[149,522,523],"Anxiety","Depression","2026-03-12",{"date":526,"type":37},"2026-03-17",{"date":528,"type":21},"2026-03-01",{"date":530,"type":21},"2026-12-01",{"name":532,"class":185},"The First Affiliated Hospital of Xinxiang Medical College",{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":537,"acronym":538,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":540,"targetDuration":4,"studyType":22,"phases":542,"briefSummary":543,"conditions":544,"keywords":545,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":160},"100607727","predicting-reactions-and-effects-of-drugs-immunotherapy-and-complications-through-oncosafety-predicto-clinical-study-100607727","NCT07192315","Predicting Reactions and Effects of Drugs Immunotherapy and Complications Through Oncosafety (PREDICTO Clinical Study)","PREDICTO","Inclusion Criteria:\n\n* Adult patient (≥18 years old)\n* Patient presenting an histologically or cytologically confirmed solid tumour malignancy\n* Patient scheduled to receive his\u002Fher first infusion of immunotherapy with anti-PD1, anti-PDL1, anti-CTLA4, anti-LAG3, alone or in combination, as part of standard care, in all validated solid oncology indications.\n* Patient must have at least one measurable lesion according to RECIST 1.1 criteria\n* Patient treated at AP-HM in one of the CEPCM-affiliated departments.\n* Patient able to comply with study procedures and follow-up schedule\n* Patient who has been informed about the study and signed the consent form\n* Patient who is a beneficiary or entitled beneficiary of a social security scheme\n\nExclusion Criteria:\n\n* Patient previously treated with ICIs\n* Patient whose treatment plan includes targeted therapy, chemotherapy or any other systemic treatment in combination with ICI\n* Patient included in a trial with an experimental molecule\n* Patient has an active autoimmune disease or any other pathology requiring systemic corticosteroid therapy at more than 10 mg prednisone equivalent per day or any other immunosuppressive drug\n* Patients with a history of organ transplantation, hematopathy or hematopoietic stem cell transplantation\n* Patient with history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Patient in emergency situations, persons deprived of their liberty by judicial or administrative decision, adults subject to legal protection measures, or persons who are unable to give their consent, or pregnant or breastfeeding.",{"count":541,"type":21},160,[171],"Immune Checkpoint Inhibitors (ICI) have revolutionized cancer therapy, providing unprecedented responses in a wide range of malignancies. However, they induced various immune-related adverse events (iRAE) that can be life-threatening. About 20% of patients treated with an ICI monotherapy, and up to 60% of patients treated with a combination of ICIs, experienced a severe iRAE. Most side effects are reversible if managed early, but can affect survival and quality of life, leading to treatment interruptions or hospitalization. Some of these irAEs, particularly those affecting hormonal functions, may be irreversible and persist even after treatment discontinuation.\n\nThe development of predictive biomarkers of such toxicities is an unmet medical need. The variety of mechanisms involved in iRAE, and the lack of effective animal models, could probably explain why the topic remains largely unexplored. To date, some biomarkers predictive of the occurrence of iRAE, irrespective of the type of organ affected, have been identified by state-of-the-art techniques on small cohorts prior to treatment initiation, but none is individually robust enough to be used in daily practice.\n\nWe hypothesize that a signature derived from the integrative analysis of various biological parameters (immunomonitoring, auto-immunity features, viral monitoring, microbiota monitoring, fragmentome analysis, pharmacokinetics, radiomics and genetics), available in routine hospital practice, could answer this question, and thus enable the development of specific prevention strategies\n\nThe objectives are :\n\nPrimary objective:\n\nIdentify a baseline predictive signature for severe iRAE, irrespective of the type of organ affected.\n\nSecondary objectives:\n\n* Identify a predictive signature for severe iRAE including baseline and T1 data, irrespective of the type of organ affected.\n* Identify a baseline predictive signature for organ-specific severe iRAE.\n* Identify a predictive signature for organ-specific severe iRAE including baseline and T1 data.\n* Identify a baseline predictive signature for severe iRAE, irrespective of the type of organ affected, for patient receiving an anti-PD(L)1 in monotherapy.\n* Identify a baseline predictive signature for severe iRAE, irrespective of the type of organ affected, for patient receiving an anti-PD(L)1 in combination.\n* Identify a baseline predictive signature for severe iRAE, irrespective of the type of organ affected, for each specific immunotherapy received.\n* Compare the predictive signatures between responders and non-responders according to RECIST 1.1 in order not to overlook the influence of clinical response on the variability observed.\n* Describe the results obtained for each biological parameter between severe irAEs and non-severe irAEs patients.\n* Describe patient-reported outcomes and quality of life parameters.",[27,414],[546,547,548],"immuno-induced adverse events","Immune checkpoint inhibitor","baseline predictive signature","2026-03-11",{"date":551,"type":37},"2026-03-13",{"date":553,"type":21},"2026-04",{"date":555,"type":21},"2028-01",{"name":557,"class":185},"Assistance Publique Hopitaux De Marseille",{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":565,"targetDuration":4,"studyType":22,"phases":567,"briefSummary":568,"conditions":569,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":577,"locationsCount":578},"100592544","phase-1-a-study-to-investigate-the-safety-and-efficacy-of-kqb168-as-monotherapy-and-in-combination-in-participants-with-advanced-solid-malignancies-100592544","NCT06994806","A Study to Investigate the Safety and Efficacy of KQB168 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies","A Phase 1, Open-label, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB168 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Malignancies","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of solid tumor malignancy.\n* Unresectable or metastatic disease that has progressed on immunotherapy.\n* No available treatment with curative intent\n* Adequate organ function\n* Measurable disease per RECIST v1.1\n\nExclusion Criteria:\n\n* Active primary central nervous system tumors\n* Cardiac abnormalities\n* History of lung diseases\n* Any condition that may impair drug absorption or prevent oral dosing\n* Known history of immune-mediated colitis and uncontrolled autoimmune diseases",{"count":566,"type":21},84,[24],"The goal of this clinical trial is to learn if KQB168 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB168. The main questions it aims to answer are:\n\n* What is the safe dose of KQB168 by itself or in combination with pembrolizumab?\n* Does KQB168 alone or in combination with pembrolizumab decrease the size of the tumor?\n* What happens to KQB168 in the body?\n\nParticipants will:\n\n* Take KQB168 daily, alone or in combination with pembrolizumab\n* Visit the clinic about 8 times in the first 8 weeks, and then once every 3 weeks after that",[27],"2026-02-27",{"date":572,"type":37},"2026-03-03",{"date":574,"type":37},"2025-06-24",{"date":576,"type":21},"2028-05-31",{"name":395,"class":44},15,{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":584,"acronym":4,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":586,"targetDuration":4,"studyType":22,"phases":588,"briefSummary":589,"conditions":590,"keywords":596,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":604,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":396},"100595269","phase-1-study-of-cp-383-in-patients-with-advanced-or-metastatic-solid-tumors-100595269","NCT07030257","Study of CP-383 in Patients With Advanced or Metastatic Solid Tumors","A Multi-Center, Open Label, Phase 1\u002F2 Study of CP-383, in Patients With Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Measurable or non measurable cancer that the research can assess for changes\n* Not eligible or able to take existing standard therapies for cancer\n* Availability of a part of a tumor for laboratory testing or willing to have a safe biopsy taken from a tumor\n* Diagnosed with locally advanced, recurrent or metastatic incurable disease\n* Part 1: any solid tumor (with the exception of brain cancer) that has progressed, standard therapy is no longer or has not helped the cancer, or is too toxic and for whom a clinical trial is an option for continued treatment\n* Part 1: specific advanced, metastatic tumor types will also be enrolled: colorectal cancer, small cell lung cancer, head and neck cancer, non-small cell lung cancer, pancreatic cancer, bladder cancer - some of these will have a specific gene mutation in the cancer\n* Part 1: selected solid tumor cancer types (with the exception of brain cancers) that have a specific gene mutation in the cancer\n* Part 2: specific advanced, metastatic tumor types will also be enrolled: colorectal cancer, small cell lung cancer, head and neck cancer - some of these will have a specific gene mutation in the cancer\n\n  \\_ Part 2: selected solid tumor cancer types (with the exception of brain cancers) that have a specific gene mutation in the cancer\n* Adequate blood and urine lab tests\n* Women and men of childbearing potential with adequate contraception\n* Provides written informed consent\n* Willing to comply with the requirements of the protocol\n\nExclusion Criteria:\n\n* Inability to swallow pills\n* Known history of HIV, HCV, HBV unless cured, controlled with undetectable viral load\n* Active tumor in the brain\n* Clinically significant liver disease\n* Significant gastrointestinal diseases\n* History of other cancer within past 5 years with certain exceptions for cancers that are likely cured\n* Significant cardiac disease\n* Other diseases that are not well controlled that could make taking the drug unsafe\n* pregnant or lactating females\n* Exposure to certain anti-cancer or other drugs within a certain period before the start of study drug",{"count":587,"type":21},150,[24,115],"The goal of this clinical trial is to learn if an investigational drug CP-383 works to treat advanced cancer. It will also learn about the safety of CP-383. The main questions if aims to answer are:\n\n* Does CP-383 slow or stop the growth of cancer in patients with advanced cancer\n* What medical problems do participants have when taking CP-383 Researchers will test CP-383 in all kinds of cancers at various dose levels to determine what the best dose is to study further. Researchers will also see if certain cancers that have gene mutations respond better to CP-383\n\nParticipants will:\n\n* Take CP-383 every day by mouth until the researcher learns whether CP-383 is helping slow or reduce the cancer growth\n* Visit the clinic weekly for the first 6 weeks for checkups and tests\n* Visit the clinic every 3 weeks thereafter for checkups and tests",[27,591,592,593,271,594,595],"Colorectal Carcinoma","Small Cell Lung Cancer ( SCLC )","Head and Neck (HNSCC)","Non-Small Cell Lung Cancer","Pancreatic Cancer, Advanced or Metastatic",[597,598,599,600,601,602],"Phase 1","Dose Escalation","Dose Expansion","Loss of Function","FAT1","P300","2026-02-17",{"date":605,"type":37},"2026-02-18",{"date":607,"type":37},"2025-08-27",{"date":609,"type":21},"2029-02",{"name":611,"class":44},"Tasca Therapeutics",{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":4,"eligibilityCriteria":618,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":619,"targetDuration":4,"studyType":22,"phases":620,"briefSummary":621,"conditions":622,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":629,"lastUpdatePostDateStruct":630,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":160},"100622993","phase-1-a-study-of-sh009-injection-in-patients-with-advanced-solid-tumors-100622993","NCT07390838","A Study of SH009 Injection in Patients With Advanced Solid Tumors.","An Open, Multicenter, Phase I Clinical Study on the Safety, Efficacy, and Pharmacokinetics of SH009 Injection in Patients With Advanced Solid Tumors.","Inclusion Criteria:\n\n* (1) Age≥18 years old at the time of informed consent, male or female;\n* (2) Subjects with histologically confirmed locally advanced, recurrent, or metastatic solid tumors (including but not limited to colorectal cancer, gastric cancer, hepatocellular carcinoma, head and neck cancer, breast cancer, non-small cell lung cancer, esophageal cancer, etc.) who have experienced disease progression or intolerance to at least one prior line of systemic therapy, and for whom no acceptable standard therapy exists or who cannot benefit from or tolerate standard therapy;\n* (3) Subjects must have at least one measurable lesion per RECIST 1.1 criteria. A lesion that has been previously irradiated can only be considered measurable if there is documented progression at that site following radiotherapy;\n* (4) Archival tumor tissue samples are available, or the subject agrees to undergo a tumor biopsy for the determination of PD-L1 and CD47 expression levels and other biomarker analyses;\n* (5) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2;\n* (6) Life expectancy ≥12 weeks;\n* (7) Bone marrow function meets the following criteria: neutrophil count ≥ 1.5 × 10\\^9\u002FL; platelet count ≥ 90 × 10\\^9\u002FL (platelet count ≥ 75 × 10\\^9\u002FL in patients with liver cancer); hemoglobin (Hb) ≥ 90 g\u002FL;\n* (8) Liver function meets the following criteria: total bilirubin(TBIL) ≤ 1.5 × ULN (total bilirubin ≤ 3 × ULN for subjects with Gilbert's syndrome); aspartate aminotransferase (AST) and alanine and aminotransferase (ALT) ≤ 3 × ULN (ALT and AST ≤ 5 × ULN for subjects with liver cancer or liver metastases);\n* (9) Renal function meets the following criteria: serum creatinine clearance(CLcr) ≥ 50 mL\u002Fmin (calculated according to Cockcroft-Gault formula); urine dipstick test results show that urine protein \\\u003C 2 +, urine protein ≥ 2 + subjects should undergo 24-hour urine collection and urine protein content \\\u003C 1g within 24 hours;\n* (10) Coagulation function meets the following criteria: prothrombin time (PT), activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5× ULN;\n* (11) Female subjects of childbearing potential must use effective contraception during the trial and for 6 months after the last dose, and have a negative pregnancy test within 7 days before treatment initiation (except those who are surgically sterilized or postmenopausal). Male subjects must agree to use effective contraception during the trial and for 6 months after the last dose;\n* (12) The subject is fully informed about this trial before its commencement and voluntarily signs and dates the informed consent form.\n\nExclusion Criteria:\n\n* (1) Prior exposure to any CD47 antibody, SIRPα antibody, or CD47\u002FSIRPα recombinant protein;\n* (2) Prior treatment with adoptive cellular therapies such as CAR-T, TCR-T, or TIL. Prior administration of an anti-cancer vaccine, or use of live or live-attenuated vaccines within 4 weeks prior to the first dose;\n* (3) Systemic anti-tumor therapies within the specified timeframes prior to the first dose of study drug: Chemotherapy, antibody-based targeted therapy, endocrine therapy, or immunotherapy within 3 weeks. Mitomycin or nitrosoureas within 6 weeks. Oral fluoropyrimidines (e.g., S-1, capecitabine) and small molecule targeted agents within 2 weeks or 5 half-lives of the drug (whichever is longer).Chinese\u002Fherbal medicines with anti-cancer activity indicated in their labeling must be discontinued prior to enrollment. Prior radical radiotherapy within 3 months before study drug administration is excluded. Palliative radiotherapy administered within 2 weeks prior to dosing is allowed if the dose meets local palliative care standards and the radiation field covers less than 30% of the bone marrow area;\n* (4) Received any investigational drug within 28 days before administration of this trial, or participated in another clinical study at the same time, except for the following circumstances: the patient participated in an observational, non-interventional clinical study, or was in the follow-up period after the end of treatment in an interventional clinical study but the drug withdrawal had exceeded the washout period;\n* (5) Had major organ surgery (excluding puncture biopsy) or had significant trauma within 4 weeks before the first administration, or needed to undergo elective surgery during the trial period;\n* (6) Patients who received systemic glucocorticoids (dexamethasone \\> 10 mg\u002F day or equivalent dose of the same drug) or other immunosuppressive therapy within 14 days before the first administration; except for topical, ocular, intra-articular, intranasal, and inhaled glucocorticoids; short-term use of glucocorticoids for prophylactic treatment (e.g., prevention of contrast allergy);\n* (7) Symptomatic brain parenchymal or leptomeningeal metastases, deemed by the investigator as unsuitable for enrollment;\n* (8) Prior immunotherapy with ≥Grade 3 irAE or ≥Grade 2 immune-related myocarditis;\n* (9) Severe or uncontrolled systemic disease, including but not limited to: uncontrolled pleural or peritoneal effusion; uncontrolled diabetes; ventricular arrhythmia requiring intervention; acute coronary syndrome, congestive heart failure, stroke, or other ≥Grade 3 cardiovascular event within 6 months; NYHA Class ≥II or LVEF \\\u003C50%; clinically significant QTcF prolongation or arrhythmia risk (baseline QTcF \\>450 msec for males or \\>470 msec for females); clinically uncontrolled hypertension (SBP \\>160 mmHg and\u002For DBP \\>90 mmHg after treatment) as judged by the investigator. Subjects judged by the investigator as unsuitable due to any such condition;\n* (10) History of pneumonia requiring hormone therapy or interstitial lung disease (including past and current history); active pulmonary infection;\n* (11) Active infection requiring intravenous anti-infective therapy within 1 week prior to study drug administration (fever attributed to the tumor per investigator's judgment is acceptable). History of self-limited infections that have resolved is acceptable;\n* (12) Active Hepatitis B, Hepatitis C, or syphilis infection. Subjects positive for HBeAb or HBsAg are eligible if HBV-DNA ≤200 IU\u002FmL. Subjects positive for HCV-Ab are eligible if HCV-RNA ≤ the upper limit of normal at the research center. Subjects with hepatocellular carcinoma and HBV-DNA ≥2000 IU\u002FmL must receive antiviral\u002Fhepatoprotective therapy first and can only enroll after HBV-DNA decreases to \\\u003C2000 IU\u002FmL;\n* (13) History of primary immunodeficiency, including positive human immunodeficiency virus (HIV) test, or suffering from other acquired, congenital immunodeficiency diseases;\n* (14) History of other malignancies within 5 years prior to the first dose, except for:\n\n  a) Any other invasive malignancy, treated with curative intent, with a disease-free interval \\>3 years and deemed by the investigator not to affect efficacy evaluation for the current tumor. b) Adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or other locally cured cancers;\n* (15) History or presence of autoimmune disease within 2 years, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis or high risk (e.g., post-transplant immunosuppression). Exceptions: stable type 1 diabetes on fixed-dose insulin; autoimmune hypothyroidism on hormone replacement only; skin conditions not requiring systemic treatment (e.g., eczema, rash covering\\\u003C10% BSA, psoriasis without ocular symptoms);\n* (16) Arterial thromboembolic events within 6 months prior to the first dose, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack. History of deep vein thrombosis, pulmonary embolism, or other serious thromboembolism within 3 months prior to the first dose (catheter-related or superficial venous thrombosis is not considered \"serious\"). Receiving thrombolytic or anticoagulant therapy for high thrombotic risk;\n* (17) Subjects who had receive allogeneic hematopoietic stem cell transplantation or solid organ transplantation (except corneal transplant);\n* (18) According to CTCAE 5.0, adverse reactions from previous anti-tumor therapy have not yet returned to ≤ grade 1 (except for toxicities which are judged by researchers to be safe, such as hair loss, pigmentation, hypothyroidism stabilized by hormone replacement therapy and peripheral neuropathy (need to recover to ≤ grade 2)). Irreversible toxicity (e.g., hearing loss) that is not reasonably expected to be aggravated by the study drug may be allowed after consultation with the medical monitor;\n* (19) Known history of severe hypersensitivity to macromolecular protein preparations\u002Fmonoclonal antibodies(CTCAE v5.0 Grade ≥3), or any component of the study drug;\n* (20) Known alcohol and\u002For drug dependence, or any other condition deemed by the investigator to affect the safety or compliance of the study treatment, including but not limited to psychiatric disorders;\n* (21) Pregnant or lactating women.",{"count":587,"type":21},[24],"Evaluate the efficacy and safety of SH009 injection therapy for patients with advanced solid tumors",[623,624,625,626,627,628,27],"Liver Cancer (Locally Advanced or Metastatic)","Lung Cancer (NSCLC)","Head and Neck Cancer Squamous Cell Carcinoma","Breast Cancer (Locally Advanced or Metastatic)","Esophageal Cancer","Gastric Cancer (GC)","2026-01-28",{"date":631,"type":37},"2026-02-05",{"date":633,"type":37},"2025-05-16",{"date":635,"type":21},"2028-12-30",{"name":637,"class":44},"Nanjing Sanhome Pharmaceutical, Co., Ltd.",{"id":639,"slug":640,"hasResults":12,"nctId":641,"briefTitle":642,"officialTitle":642,"acronym":4,"eligibilityCriteria":643,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":193,"enrollmentInfo":644,"targetDuration":4,"studyType":22,"phases":645,"briefSummary":646,"conditions":647,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":648,"lastUpdatePostDateStruct":649,"startDateStruct":651,"completionDateStruct":653,"leadSponsor":655,"locationsCount":160},"100620926","phase-1-a-phase-i-first-in-human-open-label-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-preliminary-anti-tumor-activity-of-swa1211-tablets-in-subjects-with-advanced-solid-tumors-100620926","NCT07363967","A Phase I First-in-Human Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of SWA1211 Tablets in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Subjects who are fully informed of the purpose, nature, method, and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent document before any study procedure.\n2. Subjects aged between 18 to 75 years old, male or female when signing the informed consent form (ICF).\n3. Study population:\n\n   Phase Ia (Dose Escalation Study): Subjects with histologically or cytologically confirmed advanced solid tumors, who have failed standard treatments, have no available standard treatment, or are not suitable for standard treatment at present.\n\n   Phase Ib (Dose Expansion Study): Subjects with histologically or cytologically confirmed advanced solid tumors, who have failed standard treatments, have no available standard treatment, or are not suitable for standard treatment at present. The specific tumor types will be adjusted based on the results of Phase Ⅰa (dose escalation study).\n4. Tumor tissue samples (preferable but not mandatory; fresh or archived) from patients will be collected during the screening period to assay the expression of HPK1. However, patient enrollment is not based on HPK1 expression levels.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Life expectancy of at least 3 months.\n7. The function of bone marrow reserve and organs must meet the following requirements (without ongoing continuous supportive treatment):\n\n   Bone marrow reserve: Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL, platelet count (PLT) ≥ 90 × 109\u002FL, and hemoglobin (Hgb) ≥ 9.0 g\u002FdL (no blood transfusion or hematopoietic stimulating factor therapy within 14 days).\n\n   Coagulation function: Activated partial thromboplastin time (APTT) prolongation ≤ 1.5 × upper limit of normal (ULN), and international normalized ratio (INR) ≤ 1.5.\n\n   Liver function: Total bilirubin (TBIL) ≤ 1.5 × ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (if there is liver metastasis, ALT or AST ≤ 5 × ULN).\n\n   Kidney function: Creatinine clearance rate ≥ 60 mL\u002Fmin (using the Cockcroft-Gault formula, see Appendix 1 for details); qualitative urine protein ≤ 1+, or qualitative urine protein ≥ 2+, but 24-hour urine protein \\\u003C 1 g.\n\n   Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%; corrected QT interval (QTcF) ≤ 470 ms regardless of sex.\n8. Subjects must have at least 1 evaluable lesion (only for Phase Ⅰa) or at least 1 measurable lesion (only for Phase Ⅰb) as defined by RECIST v1.1.\n9. Eligible subjects with fertility (male and female) must agree to use reliable contraceptive methods (hormonal or barrier method or abstinence, etc., see Appendix 2 for details) with their partners during the study period and for at least 3 months after the last dose of the IP. For Female subjects of childbearing age, pregnancy test within 3 days before the first dose of IP must be negative.\n\nSubjects who are able to communicate well with investigators, understand and adhere to the study requirements.\n\nExclusion Criteria:\n\n1. Known to be allergic to SWA1211 tablets or any of their excipients (Polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer; Vitamin E polyethylene glycol succinate, VE-TPGS 1000; Hypromellose; Propyl gallate; Methanol; Dichloromethane; Sodium lauryl sulfate; Microcrystalline cellulose; Manitol; Crospovidon; Silicon dioxide; Sodium stearyl fumarate; Film coating premix (Gastric dissolve type)).\n2. Prior treatment with hematopoietic progenitor cell kinase 1 (HPK1) inhibitors.\n3. Receipt of chemotherapy, radiotherapy, biological therapy, endocrine therapy, immune checkpoint inhibitor therapy, or other anti-tumor therapies within 4 weeks or 5 times the half-life of the drugs (whichever is longer) before the first dose of IP, except for the following items:\n\n1)Have used nitrosourea or Mitomycin C within 6 weeks before the first dose of IP.\n\n2)Have used oral fluorouracil and small molecule targeted drugs within 2 weeks or 5 times the half-life of the drugs before the first dose of IP (whichever is longer).\n\n3)Have used herbal therapies with anti-tumor indications within 2 weeks before the first dose of IP.\n\n4.Have received other clinical study drugs or treatments within 4 weeks before the first dose of IP, or still being within the safe follow-up period of other clinical study drugs or treatments.\n\n5.Have received systemic glucocorticoids (\\> 10 mg\u002Fday of prednisone or equivalent), or other immunosuppressants within 14 days before the first dose of IP, with the following exceptions:\n\n1. Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent).\n2. Topical, ocular, intra-articular, intranasal, or inhalational corticosteroid with minimal systemic absorption.\n3. Short course (≤ 7 days) of corticosteroids prescribed prophylactically (e.g., for contrast dye allergy) or for the treatment of a non-autoimmune condition (e.g., delayed-type hypersensitivity reaction caused by a contact allergen).\n\n6.Use of CYP3A4 or CYP2C8 strong inducers or inhibitors within 14 days or 5 times the half-life of the drugs (whichever is longer) before the first dose of IP (see Appendix 3 for details).\n\n7.Use of P-gp strong inhibitors, or P-gp substrates within 14 days or 5 times the half-life of the drugs (whichever is longer) before the first dose of IP (see Appendix 3 for details).\n\n8.Use of acid-reducing agents (ARAs) (e.g., histamine H2-receptor antagonists (H2 blockers), and proton pump inhibitors (PPIs)) within 14 days or 5 times the half-life of the drugs (whichever is longer) before the first dose of IP.\n\n9.Major organ surgery (excluding biopsy) or significant trauma or invasive dental procedures (such as tooth extraction, dental implants) within 4 weeks before the first dose of IP, or the requirement for elective surgery during the study period.\n\n10.Have serious unhealable wounds, ulcers, or bone fractures within 4 weeks before the first dose of IP.\n\n11.Bleeding events of grade 3 or above within 6 months before the first dose of IP, or currently ≥ grade 2 bleeding or factors judged by the investigator to have a high risk of bleeding (such as active peptic ulcer or esophageal varices) at present.\n\n12.The adverse reactions of previous anti-tumor therapies have not yet recovered to ≤ grade 1 of CTCAE v5.0 (except for toxicities judged by the investigator to have no safety risk, such as hair loss, grade 2 peripheral neurotoxicity, etc.).\n\n13.Have received immunotherapy and experienced ≥ grade 3 immune-related adverse events (irAEs), or ≥ grade 2 immune-related myocarditis.\n\n14.Central nervous system metastasis or meningeal metastasis with clinical symptoms, or other evidence that such metastases have not been controlled, and the investigator judges it to be unsuitable for inclusion; 15.Gastrointestinal perforation, abdominal fistula, or intra-abdominal abscess occurred within 6 months before the first dose of IP, or the investigator has determined that there are high-risk factors for the formation of cavity organ perforation\u002Ffistula (such as tumor infiltration in the cavity Outer layer of the wall); inflammatory bowel disease (including ulcerative colitis and Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis.\n\n16.Unable to be dosed orally, or there are conditions judged by the investigator to seriously affect gastrointestinal absorption, such as dysphagia, uncontrolled nausea and vomiting, intestinal obstruction, chronic gastritis, gastroparesis syndrome, or gastric outlet obstruction.\n\n17.Have active autoimmune conditions, or have a history of autoimmune diseases that may relapse (excluding well-controlled type 1 diabetes mellitus; manageable hypothyroidism with hormone replacement therapy only, or skin diseases that do not require systemic treatment, such as vitiligo or psoriasis).\n\n18.Have active infection requiring systemic anti-infective treatment. 19.HIV infection, active HBV infection (with HBV DNA exceeding the ULN), or active HCV infection (with HCV RNA exceeding the ULN).\n\n20.Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to:\n\n1. Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia that requires clinical intervention, or grade Ⅱ-Ⅲ atrioventricular block.\n2. Thromboembolic events requiring therapeutic anticoagulation, or subjects with venous filters.\n3. Subjects with grade III \\~ IV cardiac insufficiency according to the New York Heart Association (NYHA) standards.\n4. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other cardiovascular and cerebrovascular events of grade 3 or above occurring within 6 months before the first dose of the IP.\n5. Clinically uncontrollable hypertension (where blood pressure cannot be controlled at systolic blood pressure \\\u003C 140 mmHg and diastolic blood pressure \\\u003C 90 mmHg after standard antihypertensive treatment).\n6. Any factors that increase the risk of QTc prolongation or arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, or the use of any concomitant drugs known or suspected to prolong the QT interval.\n\n21.Presence of clinically uncontrollable third-space effusion, as judged by the investigator.\n\n22.History of interstitial lung disease (ILD) or evidence of history of pneumonitis on chest computed tomography scan within the 6 months before the first dose of the IP. Or interstitial lung disease that still requires glucocorticoid treatment at present (patients with radiation-induced pulmonary fibrosis not requiring hormone therapy are allowed to enroll).\n\n23.Have a history of other malignant tumors within the 5 years before the first dose of the IP. However, patients with controlled basal cell carcinoma of the skin, cervical carcinoma in situ, breast carcinoma in situ, or squamous cell carcinoma of the skin may be enrolled.\n\n24.Known history of drug abuse. 25.Presence of mental disorders or poor compliance. 26.Women who are pregnant or breastfeeding. 27.Inability to tolerate venous blood sampling. History of other serious systemic diseases, or other reasons judged by the investigator to make the subject unsuitable for participation in the study.",{"count":169,"type":21},[24],"The goal of this phase I, first-in-human, open-label study is to evaluate the safety, tolerability, PK, and preliminary anti-tumor activity of SWA1211 in subjects with advanced solid tumors. It includes a Phase Ia dose escalation study and a Phase Ib dose expansion study. The main questions it aims to answer are:\n\n1. Assess the safety and tolerability of SWA1211 in subjects with advanced solid tumors.\n2. Identify the dose-limiting toxicity (DLT) to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) and\u002For the recommended Phase II dose (RP2D) of SWA1211.\n3. Assess the PK characteristics of SWA1211.\n4. Evaluate the preliminary anti-tumor activity of SWA1211.",[27],"2026-01-15",{"date":650,"type":37},"2026-01-23",{"date":652,"type":37},"2025-06-13",{"date":654,"type":21},"2028-02-01",{"name":656,"class":44},"Beijing StoneWise Technology Co., Ltd",{"id":658,"slug":659,"hasResults":12,"nctId":660,"briefTitle":661,"officialTitle":662,"acronym":4,"eligibilityCriteria":663,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":664,"targetDuration":4,"studyType":22,"phases":666,"briefSummary":667,"conditions":668,"keywords":670,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":675,"lastUpdatePostDateStruct":676,"startDateStruct":678,"completionDateStruct":680,"leadSponsor":682,"locationsCount":684},"100606893","phase-1-a-study-to-evaluate-the-safety-pharmacokinetics-and-efficacy-of-tj101-in-patients-with-advancedmetastatic-solid-tumors-100606893","NCT07181473","A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of TJ101 in Patients With Advanced\u002FMetastatic Solid Tumors","A Phase I, First in Human (FIH), Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Preliminary Efficacy and Immunogenicity of TJ101 for Injection in Patients With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Histological and\u002For cytological diagnosis of advanced\u002Fmetastatic solid tumors, who have failed standard treatment, or have no standard therapy.\n2. Have at least one measurable lesion by RECIST v1.1 (Eisenhauer et al., 2009) for solid tumors.\n3. Men or women ≥18 years old.\n4. Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) of 0 to 1.\n5. Life expectancy of ≥ 12 weeks;\n6. Patients with adequate organ function and the laboratory test criteria specifically defined as follows within 7 days prior to the first dosing.\n\n   * Hepatic function: AST and ALT ≤ 2.5 x upper limit of normal (ULN); if liver metastases, then ≤ 5 x ULN. Total bilirubin ≤ 1.5 x ULN or ≤ 3 x ULN in the presence of documented Gilbert's Syndrome.\n   * Albumin ≥3g\u002FdL.\n   * Coagulation function: International normalized ratio (INR) ≤ 1.5×ULN; APTT≤1.5×ULN.\n   * Renal function: Creatinine clearance ≥ 60 mL\u002Fmin (calculated by Cockcroft and Gault equation) (Cockcroft DW, 1976)\n   * Hematopoietic function (without infusion of blood product, use of G-CSF or other treatments to correct blood count within 14 days): Hemoglobin (HGB) ≥ 90 g\u002FL; Platelet count (PLT) ≥ 100×109\u002FL; Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL;\n7. Serum pregnancy test (for female of childbearing potential) negative within 7 days prior to first dosing of study treatment. Male and female patients of childbearing potential must agree to use effective methods of contraception from the time of informed consent, throughout the study and for 6 months after the last dose of the investigational product.\n8. Willing to participate in the clinical trial, understand and sign the informed consent, and comply with the study visits and procedures.\n\nExclusion Criteria:\n\n1. Has received treatment of topoisomerase 1 inhibitors (TOP1i), including topotecan, irinotecan, belotecan, and TOP1i-based antibody-drug conjugates (ADCs, eg, sacituzumab govitecan, trastuzumab deruxtecan, zalontamab brengitecan, sacituzumab tirumotecan etal);\n2. Has known hypersensitivity to any component of TJ101 or has a history of severe hypersensitivity reactions to other monoclonal antibodies;\n3. Has received mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration; oral fluorouracil-like drugs such as S-1, capecitabine, or palliative radiotherapy within 2 weeks prior to the first administration; Has received other chemotherapy, biological therapy, immunotherapy, major surgery, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase) and other anti-tumor therapy within 5 half-lives or 28 days, whichever is shorter, prior to the first administration of TJ101; Has received anti-tumor herbal medicine within 14 days prior to first dose of TJ101;\n4. Has received a strong or moderate CYP3A4 inhibitor within 3 half-lives;\n5. Received an investigational drug within 28 days or 2 half-lives (whichever is shorter) prior to first dose of TJ101; Current participation in other interventional clinical studies (participation in survival follow-up is allowed);\n6. Toxic effects of prior anti-tumor therapy have not recovered to NCI-CTCAE V5.0 Grade ≤1 (excluding alopecia and skin pigmentation). Subject with irreversible toxicities caused by prior anti-tumor therapy (eg, hearing loss) that will not increase the safety risk may be eligible at the discretion of the Investigator.\n7. Has a history of (non-infectious) interstitial lung disease (ILD) that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis can't be ruled out by imaging at screening.\n8. Presence of severe dry eye syndrome, severe keratitis, severe conjunctivitis, or other severe conditions that may increase the risk of corneal epithelial damage at the discretion of investigator.\n9. Uncontrolled or significant cardiovascular disease, including:\n\n   Prolongation of the average Corrected QT interval (QTc, Fridericia's correction formula used) (\\> 470 ms regardless of sex).\n\n   Clinically significant arrhythmia, unstable angina pectoris, congestive heart failure (class II-IV of New York Heart Association \\[NYHA\\]) or acute myocardial infarction within preceding 6 months.\n\n   History of additional risk factors for Torsades de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).\n\n   Uncontrolled hypertension defined as systolic BP ≥160 mm Hg or diastolic BP ≥100 mm Hg while receiving more than one kind of antihypertensive drug.\n10. For patients with documented positive virology status of hepatitis, as confirmed by Screening hepatitis B virus (HBV) and hepatitis C virus (HCV) tests, only the following patients may be eligible as evaluated by the sponsor and investigator:\n\n    Patients with active hepatitis B: HBV DNA ≤500 IU\u002FmL during Screening. Patients who are hepatitis C virus antibody positive (HCV Ab+), who have controlled infection (HCV RNA≤ULN by polymerase chain reaction \\[PCR\\] either spontaneously or in response to a successful prior course of anti-HCV therapy at Screening). Patients with controlled infections must undergo periodic monitoring of HCV RNA as per treating physician.\n11. Known HIV infection;\n12. Severe infection, including but not limited to hospitalization due to infection, bacteraemia, or severe pneumonia complications, occurs within 4 weeks prior to initiation of study treatment; Or patients who received therapeutic oral or intravenous antibiotics within two weeks prior to starting study treatment, and who received prophylactic antibiotics (e.g., for the prevention of urinary tract infection or chronic obstructive pulmonary disease);\n13. Active central nervous system (CNS) metastases or meningeal metastases. Subjects may be enrolled in the study if their CNS metastases have received adequate local therapy and have been clinical stable for at least 4 weeks (ie, imaging shows no progression of the brain lesion and neurologically relevant symptoms are stable), and require a dose of prednisone of ≤20 mg\u002Fday (or equivalent dose).\n14. Other malignancies within 3 years prior to initiation of TJ101 treatment (other than non-melanoma basal cell carcinoma or squamous cell carcinoma of the skin, breast\u002Fcervical carcinoma in situ, superficial bladder carcinoma that have received radical treatment and no evidence of disease recurrence) will confound safety\u002Fefficacy of this trial or pose a risk to the participants;\n15. Female patients who are lactating or breastfeeding.\n16. The investigator believes that the subject may have other factors that may affect the results of the study and interfere with the subject's participation in the entire study process, including previous or existing physical conditions, abnormal treatment or laboratory tests, and the subject's unwillingness to comply with all procedures, restrictions, and requirements of the study.",{"count":665,"type":21},200,[24],"The goal of this clinical trial is to evaluate whether TJ101, an investigational antibody-drug conjugate (ADC), can safely and effectively treat patients with advanced solid tumors.\n\nThe main objectives of this study are :\n\n* To Determine the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) of TJ101\n* to show preliminary antitumor activity in patients with advanced solid tumors\n\nParticipants will:\n\n* Receive intravenous (IV) infusions of TJ101 at escalating dose levels (during dose escalation) or at the selected expansion dose.\n* Undergo regular tumor imaging to assess response.\n* Provide blood samples for pharmacokinetics (PK) and biomarker analysis.\n* Be monitored for side effects and overall tolerability.\n\nThis study is being conducted in adult patients with advanced or metastatic solid tumors who have exhausted standard treatment options",[624,669,627,27],"Prostate Cancer",[671,672,673,674],"TJ101","EGFR\u002FB7-H3","phase 1","Solid Tumors","2026-01-08",{"date":677,"type":37},"2026-01-12",{"date":679,"type":37},"2025-08-25",{"date":681,"type":21},"2027-09-15",{"name":683,"class":44},"Phrontline Biopharma",7]