[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nsclc-non-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nsclc-non-small-cell-lung-cancer":33},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,53,0,25,[9,48,72,114,146,224,283,314,340,372,421,449,487,522,542,577,602,628,670,714,750,775,795,819,863],{"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":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100576996","phase-1-a-phase-i-study-of-sim0505-in-participants-with-advanced-solid-tumors-100576996",false,"NCT06792552","A Phase I Study of SIM0505 in Participants With Advanced Solid Tumors","A Phase I First-in-human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0505 in Adult Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Written informed consent is obtained prior to any procedures that are not considered standard of care.\n2. ≥18 years of age.\n3. In Part 1:\n\n   1. Participants with histologically or cytologically confirmed advanced solid tumors, who have failed or are ineligible for standard of care therapies.\n   2. Have progressed on at least one prior systematic anti-tumor regimen, and presence of at least one evaluable lesion according to RECIST Version 1.1. Measurable lesions are required in the backfill period.\n   3. In the backfill period, eligible tumor types are limited to high-grade serous ovarian cancer, high-grade endometrioid ovarian cancer, USC, clear cell RCC, papillary RCC and adenocarcinoma of NSCLC without actionable mutation of epidermal growth factor receptor (EGFR). For participants with NSCLC, presence of CDH6 expression through immunohistochemical examination of tumor tissue by central laboratory is required.\n4. In Part 2: Participants must have a diagnosis of specific type of metastatic or locally advanced solid tumors and have progressed on or cannot benefit from the most recent systematic anti-tumor regimen (unless otherwise specified), with presence of at least one measurable lesion according to RECIST Version 1.1.\n\n   Platinum-resistant ovarian cancer cohort:\n   1. Participants with histologically or cytologically confirmed high-grade serous ovarian cancer, high-grade endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.\n   2. Have platinum-resistant disease, defined as: participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a best response of CR or PR, and then progressed between \\>90 days and ≤180 days after the date of the last dose of platinum; participants who have received ≥2 lines of platinum therapy must have progressed ≤180 days after the date of the last dose of platinum.\n   3. At least one line of therapy containing anti-VEGF therapy (e.g., bevacizumab or suvemcitug or their biosimilar), unless the participant is not eligible for treatment with anti- angiogenic treatment due to precautions\u002Fintolerance. Has had prior poly-ADP ribose polymerase (PARP) inhibitors for subjects with documented breast cancer gene (BRCA) mutation (germline and\u002For somatic), unless the subject is not eligible for treatment with a PARP inhibitor. Has had prior treatment with mirvetuximab soravtansine for participants with documented high folate receptor alpha expression, unless the subject is not eligible for treatment with mirvetuximab soravtansine due to precautions\u002Fintolerance, or if the treatment is not approved or available locally. In the PROC cohort, topoisomerase inhibitor payload ADC-pretreated participants should have received at least one prior topoisomerase inhibitor payload ADC.\n\n   Renal cell carcinoma cohort:\n   1. Participants with histologically- or cytologically-confirmed clear cell RCC or papillary RCC.\n   2. For clear cell RCC: Participants who have progressed on or after systemic treatment including a programmed cell death protein 1 or programmed death ligand 1 (PD-1\u002FPD-L1) checkpoint inhibitor and a vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI), either given concurrently or in separate lines of therapy.\n   3. For papillary RCC: Participants without any prior systemic treatment is acceptable.\n\n   Uterine serous carcinoma cohort:\n   1. Participants with histologically- or cytologically-confirmed USC.\n   2. Have progressed on or after systemic treatment that contained platinum-based chemotherapy.\n\n   Non-Small Cell Lung Cancer cohort:\n   1. Participants with histologically- or cytologically-confirmed adenocarcinoma of NSCLC without actionable mutation of EGFR.\n   2. Presence of CDH6 expression through immunohistochemical examination of tumor tissue.\n   3. For participants without actionable mutations: Have progressed on or after systemic treatment including anti-PD-1\u002FPD-L1 antibody and platinum-based chemotherapy, either given concurrently or in separate lines of therapy. Progression within 6 months after completion of adjuvant therapy is considered failure of first-line therapy.\n   4. For participants with actionable mutations other than EGFR: Have failed at least one established standard anti-cancer targeted therapy, anti-PD-1\u002FPD-L1 antibody and platinum-based chemotherapy (PD-1\u002FPD-L1 and chemotherapy either given concurrently or in separate lines of therapy) or in the opinion of the Investigator have been considered ineligible for a particular form of standard of care therapy on medical grounds.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n6. Life expectancy of ≥12 weeks.\n7. Have adequate organ function as indicated by the laboratory values listed within the protocol.\n8. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 72 hours prior to the start of study treatment. WOCBP or male participants who have sexual relations with WOCBP are required to use highly effective contraceptive methods, and agree to refrain from donating sperm\u002Fegg from signing of informed consent through 180 days after the last dose of study treatment.\n9. Able to provide tumor tissue sample (archival or newly obtained core or excisional biopsy). For Part 1: At biomarker-screening (for NSCLC) or screening (for non-NSCLC) visit of a tumor lesion not previously irradiated for CDH6 testing.\n\nFor Part 2: Willing to undergo fresh tumor biopsy at biomarker-screening visit (for NSCLC) and screening visit (non-NSCLC) from a lesion that can be biopsied at an acceptable clinical risk as judged by the investigator.\n\nExclusion Criteria:\n\n1. For Part 2: has clear cell, mucinous or sarcomatous histology, mixed tumors containing any histology, or low-grade\u002Fborderline ovarian cancer; mixed nonsmall cell and small cell carcinoma, or adenosquamous cell lung cancer with an adenocarcinoma component \\\u003C50% (the participant is eligible if the adenocarcinoma component is ≥50%).\n2. For Part 2: Participants with primary platinum refractory ovarian cancer, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of first line platinum-containing chemotherapy.\n3. Any other malignancy within 2 years prior to the first dose of the study treatment except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence.\n4. Known untreated CNS metastases and\u002For leptomeningeal metastases. Participants are eligible if CNS metastases have been treated and participants have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment). In addition, participants must have been either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) for at least 2 weeks prior to the first dose of study treatment. Imaging performed within 28 days prior to the first dose of study treatment must document radiographic stability of CNS lesions and be performed after completion of any CNS-directed therapy.\n5. History of bowel obstruction within 3 months prior to the first dose of study treatment.\n6. Known psychiatric disorder or drug abuse that would interfere the study requirements.\n7. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring drainage or medical intervention within 4 weeks before the first dose of study treatment.\n8. Any active infection requires systemic treatment via intravenous infusion within 2 weeks prior to the first dose of study treatment.\n9. History of non-infectious pneumonitis that has required a course of oral or intravenous steroids to assist with recovery, or interstitial lung disease (ILD) or severe obstructive pulmonary disease.\n10. Prior exposure to other CDH6-targeted agents.\n11. Prior exposure to an ADC with a topoisomerase I inhibitor payload (e.g., raludotatug deruxtecan\u002FDS-6000) for all cohorts except for the topoisomerase inhibitor payload ADC-pretreated participants in PROC cohort.\n12. Has not recovered (i.e., to CTCAE version 5.0 Grade 1 or to baseline) from previous anticancer therapy-induced AEs. Grade ≤2 AEs with no impact on participant safety are exceptions to this criterion and may qualify for the study.\n13. Currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of SIM0505.\n14. Major surgery within 2 weeks of receiving the first dose of study treatment.\n15. Has received prior anti-cancer therapies within the following time frames prior to the first dose of study treatment: previous cytotoxic therapy, anticancer targeted small molecules (e.g., tyrosine kinase inhibitors), hormonal agents within 2 weeks; anti-cancer antibody or ADC within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of study treatment; Chinese medicines\u002Fherbal preparations with anticancer indication taken within 2 weeks; and\u002For radiation therapy within 2 weeks for focal radiation or within 4 weeks for wide-field radiation.\n16. Use of any live vaccine therapy within 4 weeks prior to the first dose of study treatment.\n17. Administration of strong or moderate CYP3A4 inhibitors or drugs with known risk of Torsades de Pointes (TdP) ≤ 7 days or 3 half-lives (whichever is longer) prior to the first dose of SIM0505.\n18. Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS).\n19. Active hepatitis B or hepatitis C infection.\n20. Participants with clinically significant cardiovascular diseases.\n21. History of allogeneic organ transplantation or graft-versus-host disease.\n22. Known hypersensitivity to study drug or any of the excipients.\n23. Participant is pregnant or breastfeeding.\n24. Other conditions that researchers consider inappropriate for inclusion.","ALL","18 Years",{"count":20,"type":21},738,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is an open-label, multicenter phase 1 study to evaluate the safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0505 in Adult Participants with Advanced Solid Tumors",[27,28,29,30,31,32,33,34],"Advanced Solid Tumors","Platinum Resistant Ovarian Cancer","Fallopian Tube Cancer","Renal Cell Carcinoma (RCC)","Papillary Renal Cell Carcinoma (Prcc)","Uterine Serous Carcinoma (USC)","NSCLC (Non-small Cell Lung Cancer)","Primary Peritoneal Cancer","RECRUITING","2026-08-13",{"date":38,"type":39},"2026-08-17","ACTUAL",{"date":41,"type":39},"2025-02-26",{"date":43,"type":21},"2028-08",{"name":45,"class":46},"NextCure, Inc.","INDUSTRY",17,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100563484","phase-1-a-phase-12-open-label-multicenter-fih-study-to-evaluate-safety-tolerability-pk-and-anti-tumor-activity-of-yh42946-100563484","NCT06616766","A Phase 1\u002F2, Open-label, Multicenter, FIH Study to Evaluate Safety, Tolerability, PK and Anti-tumor Activity of YH42946","A Phase 1\u002F2, Open-label, Multicenter, FIH Study to Evaluate the Safety, Tolerability, PK and Anti-tumor Activity of YH42946 in Patients With Locally Advanced or Metastatic Solid Tumors With HER2 Aberration and EGFR Exon 20 Insertion","Inclusion Criteria:\n\n* ECOG performance status 0 or 1\n* Estimated life expectancy of at least 3 months\n* Patients who have progressed on or after all available standard therapies or for whom standard treatment is inappropriate\n* Mandatory provision of archived or fresh tumor tissue in quantity sufficient to allow for retrospective confirmation of HER2 aberration or EGFR mutation\n* A patient with a history of brain metastases must have had all lesions treated\n* Adequate organ function defined as all of the following:\n\n  * Adequate bone marrow function (within 1 week prior to first administration): Neutrophils≥1.5 x10\\*9 cells\u002FL (Criteria must be met without the use of Granulocyte-Colony Stimulating Factor (G-CSF) within last week prior to testing.); platelet count≥75 x10\\*9 cells\u002FL; Hb ≥9g\u002FdL (Criteria must be met without packed red blood cell (pRBC) transfusion within last week prior to testing.)\n  * Adequate hepatic function: Serum bilirubin≤1.5 x upper limit of normal (ULN), and serum transaminase (either aspartate transaminase (AST) or alanine transaminase (ALT)) ≤ 3 x ULN if no demonstrable liver metastases, or otherwise ≤ 5 x ULN if transaminase elevation is attributable to liver metastases (within 1 week prior to first administration)\n  * Adequate renal function: Serum creatinine ≤ 1.5 x ULN or Estimated glomerular filtration rate (eGFR) \\> 60 mL\u002Fmin per 1.73 m\\*2 according to the site's calculation method.\n  * Adequate Heart function: QTcF≤ 470 ms, LVEF≥ 50%\n  * Blood Coagulation: INR or Prothrombin time ≤ 1.5 X ULN, aPTT ≤ 1.5 X ULN\n\n\\[Dose Escalation part only\\]\n\n* Histologically or cytologically confirmed diagnosis of advanced, and\u002For metastatic non-hematologic malignancy\n* Documented HER2 aberration or EGFR mutation (HER2 mutation or EGFR exon 20 insertion, HER2 amplification or overexpression)\n\n\\[Dose Expansion part only\\]\n\n* Patients who have at least 1 measurable lesion\n* Patients with histologically or cytologically confirmed locally advanced or metastatic NSCLC HER2 exon 20 insertion (Cohort 1)\n\nExclusion Criteria:\n\n* Patient with symptomatic or progressive brain metastases\n* Known or suspected leptomeningeal disease (LMD)\n* Uncontrolled spinal cord compression\n* History of acute coronary syndromes, including myocardial infarction, coronary artery bypass graft, unstable angina, coronary angioplasty or stenting within past 24 weeks\n* History of or current Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system\n* Medical, psychiatric, cognitive or other conditions that compromise the patients ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study\n* Any severe concurrent disease or condition (includes active infections, cardiac arrhythmia) that in the judgment of the Investigator would make study participation inappropriate for the patient\n* History of (non-infectious) interstitial lung disease (ILD) or pneumonitis that required steroids, or any evidence of current ILD or pneumonitis\n* History of a second primary cancer with the exception of\n\n  1. curatively treated non-melanomatous skin cancer,\n  2. curatively treated cervical or breast carcinoma in situ, or\n  3. other malignancy with no known active disease present and no treatment administered during the last 2 years\n* Infection with Human immunodeficiency virus (HIV) infection, or active chronic hepatitis B or chronic hepatitis C\n* Major surgery within 4 weeks prior to the first dose of study treatment",{"count":56,"type":21},201,[24,58],"PHASE2","The goal of this YH42946-101 is to evaluate the safety, Tolerability, Pharmacokinetics and anti-tumor activity of YH42946 in patients with locally advanced of metastatic solid tumors with HER2 aberration and EGFR exon 20 insertions.",[33,61],"Solid Tumor",[63],"YH42946-101",{"date":38,"type":39},{"date":66,"type":39},"2024-10-02",{"date":68,"type":21},"2028-07-29",{"name":70,"class":46},"Yuhan Corporation",8,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":17,"minAge":79,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":97,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":113},"100480603","phase-1-a-study-to-learn-about-the-study-medicine-called-pf-07799544-as-monotherapy-or-in-combination-in-people-with-advanced-solid-tumors-100480603","NCT05538130","A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors","A PHASE 1A\u002FB OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH BRAF-MUTANT MELANOMA AND OTHER SOLID TUMORS","Phase 1b Inclusion Criteria:\n\n* Diagnosis of advanced\u002Fmetastatic solid tumor (excluding colorectal cancer)\n* Measurable disease by RECIST version 1.1\n* Evidence of a BRAF V600 mutation\n* Prior therapy per tumor cohort\n* Adequate organ function per protocol\n\nPhase 1b Exclusion Criteria:\n\n* Other active malignancy within 3 years\n* Presence of leptomeningeal disease\n* History or current evidence of retinal vein occlusion (RVO) or history of retinal degenerative disease\n* Concurrent neuromuscular disorder associated with elevated creatine kinase (CK)\n* Active gastrointestinal disease as defined per protocol\n* History of interstitial lung disease as defined per protocol","16 Years",{"count":81,"type":21},124,[24],"The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors. The study will be conducted in two parts: PF-07799544 as a single agent (Phase 1a) and PF-07799544 in combination with another study medicine called PF-07799933 (Phase 1b).\n\nPhase 1a is no longer open for enrollment. In Phase1b (noted as \"this study\"), we are seeking participants who have:\n\n* a solid tumor which is metastatic or recurrent (excluding colorectal cancer)\n* tumor with the mutation (abnormal gene) called \"BRAF V600\"\n* received required prior treatment for cancer per cohort assigned.\n\nAll participants in this study will receive both study medicines. Both study medicines are tablets that are taken by mouth at home twice a day.\n\nParticipants will receive study medicines until their cancer is no longer responding, unacceptable side effects, or 2 years. Participants may continue to receive study therapy beyond 2 years. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective.",[85,86,87,88,89,90,91,92,93,94,95,96,33],"Melanoma","Glioma","Thyroid Cancer","Non-Small Cell Lung Cancer","Malignant Neoplasms","Brain Neoplasms","Advanced or Metastatic Solid Tumors","HGG","LGG","Low Grade Glioma","High Grade Glioma","Differentiated Thyroid Cancer",[98,99,100,101,102,103,104],"solid tumors","BRAF","advanced solid tumors","B-Raf","MAPK","neoplasms","BRAF V600",{"date":106,"type":39},"2026-08-14",{"date":108,"type":39},"2022-11-30",{"date":110,"type":21},"2029-06-18",{"name":112,"class":46},"Pfizer",83,{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":125,"conditions":126,"keywords":129,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":145},"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":122,"type":21},12,[124],"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",[33,87,127,128],"Solid Tumor Malignancies","Advanced Malignancies",[130,131,132,133,134,135],"Oncology","Drug-Drug Interactions","Medical Oncology","RET Fusion Positive","RET Gene Mutation","Pharmacokinetic (PK)","2026-08-07",{"date":138,"type":39},"2026-08-10",{"date":140,"type":39},"2026-03-04",{"date":142,"type":21},"2027-08-30",{"name":144,"class":46},"Rigel Pharmaceuticals",2,{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":12,"sex":17,"minAge":153,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":22,"phases":156,"briefSummary":157,"conditions":158,"keywords":187,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":216,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":223},"100407463","the-evaluation-of-pc14586-in-patients-with-advanced-solid-tumors-harboring-a-tp53-y220c-mutation-pynnacle-100407463","NCT04585750","The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","A Phase 1\u002F2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","Inclusion Criteria:\n\n* At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.\n* Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Previously treated with one or more lines of anticancer therapy and progressive disease\n* Adequate organ function\n* Measurable disease per RECIST v1.1 (Phase 2)\n\nAdditional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Anti-PD-1\u002FPD-L1 naive or must have progressed on treatment\n* Measurable disease\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug\n* Radiotherapy within 14 days of receiving the study drug\n* Primary CNS tumor\n* History of leptomeningeal disease or spinal cord compression\n* Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms\n* Stroke or transient ischemic attack within 6 months prior to screening\n* Heart conditions such as unstable angina within 6 months prior to screening, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities\n* Strong CYP3A4 inducers and strong CYP2C9 inhibitors\u002Finducers within 14 days of first dose of rezatapopt\n* History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication\n* History of prior organ transplant\n* Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n* Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection\n\nAdditional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy)\n\n* Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2)\n\nAdditional Criteria for Exclusion from Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)\n* Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention\n* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug\n* Hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* History of radiation pneumonitis\n* History of (non-infectious) or active pneumonitis \u002F interstitial lung disease that required steroids\n* Active infection requiring systemic therapy\n* Known history of HIV infection\n* Has previously received rezatapopt","12 Years",{"count":155,"type":21},300,[24,58],"The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.",[159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,33,177,178,179,180,181,88,182,183,184,185,186],"Advanced Solid Tumor","Advanced Malignant Neoplasm","Metastatic Cancer","Metastatic Solid Tumor","Lung Cancer","Ovarian Cancer","Endometrial Cancer","Prostate Cancer","Colorectal Cancer","Breast Cancer","Other Cancer","Locally Advanced","Head and Neck Cancer","Gall Bladder Cancer","Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )","Small Cell Lung Carcinoma","NSCLC","SCLC","Non-Small Cell Lung Carcinoma","Triple Negative Breast Cancer","TNBC","HER2+ Breast Cancer","ER\u002FPR Positive Breast Cancer","HER2- Breast Cancer","HER2-positive Breast Cancer","HER2-negative Breast Cancer","ER\u002FPR(+), Her2(-) Breast Cancer",[188,189,190,191,192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210,211,212,213,214,215],"PC14586","p53","Y220C","Phase 1","Phase 1\u002F2","PMV","PMV Pharma","p53 mutation","TP53","TP53 mutation","p53 mutant","p53 reactivator","pembrolizumab","Keytruda","combination","PD-1","PD-L1","anti-PD-1","Merck","MSD","IgG4","mAb","Phase 1b","NGS","Next Generation Sequencing","precision","Phase 2","Rezatapopt",{"date":138,"type":39},{"date":218,"type":39},"2020-10-29",{"date":220,"type":21},"2027-12-31",{"name":222,"class":46},"PMV Pharmaceuticals, Inc",77,{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":22,"phases":234,"briefSummary":235,"conditions":236,"keywords":248,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":282},"100484789","phase-1-a-study-of-a-selective-t-cell-receptor-tcr-targeting-bifunctional-antibody-fusion-molecule-star0602-in-participants-with-advanced-solid-tumors-100484789","NCT05592626","A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors","A Phase 1\u002F2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule, in Subjects With Unresectable, Locally Advanced, or Metastatic Solid Tumors That Are Antigen-rich (START-001)","START-001","Inclusion Criteria:\n\n1. Participants must have histologically confirmed solid tumors that are unresectable, locally advanced, or metastatic and for which standard curative therapies do not exist or are no longer effective or have intolerable toxicities. Participants should not have received more than three regimens of prior therapies for their advanced or metastatic diseases. For Phase 2 Cohorts 8 and 10 (see below), participants should not have received more than one line of prior therapy.\n2. For Phase 1, participants must have one of the following solid tumors:\n\n   1. High mutational burden (TMB-H)\n   2. Microsatellite Instability (MSI-H)\u002FDNA mismatch repair (dMMR)\n   3. Virally associated tumors\n   4. Solid tumors generally considered as immunogenic (e.g., melanoma and renal cell carcinoma) are eligible without prior testing for TMB, MSI or viral status after the Sponsor's approval.\n3. For Phase 2, participants must have one of the following solid tumors:\n\n   1. TMB-H (not enrolling)\n   2. MSI-H\u002FdMMR (not enrolling)\n   3. CRC (both Ras wild type and mutant) (not enrolling)\n   4. NSCLC (recurrent or Primary Stage 4)\n   5. CRC with pMMR\u002FMSS (without TMB-H requirement)\n\n   (Other tumor histologies may also be included in Phase 2 as additional data emerge to support their inclusion.)\n4. Symptomatic central nervous system (CNS) metastases must have been treated, be asymptomatic for ≥ 14 days, and meet the following at the time of enrollment:\n\n   * No concurrent treatment for CNS disease (e.g., surgery, radiation, corticosteroids \\> 10 mg prednisone\u002Fday or equivalent);\n   * No concurrent leptomeningeal disease or cord compression.\n5. Subjects who have previously received a CPI (e.g., anti-PD-L1, anti-PD-1, anti CTLA 4) prior to enrollment must have CPI immune-related toxicity resolved to either Grade ≤ 1 or baseline (prior to the CPI) to be eligible for enrollment.\n\n   * Subjects who experienced previous CPI-related endocrine abnormalities are eligible for the study regardless of CTCAE grade if well controlled on replacement therapy.\n   * Subjects who have had previous CPI-related Grade 3 to 4 pneumonitis, peri\u002Fmyocarditis, colitis and bowel perforation, myositis, encephalitis, or peripheral neuropathy will need Sponsor approval.\n\nExclusion Criteria:\n\n1. Participants with a history of known autoimmune disease with exceptions of:\n\n   * Vitiligo;\n   * Psoriasis, atopic dermatitis or other autoimmune skin condition not requiring systemic treatment;\n   * History of Graves' disease, now euthyroid for \\> 4 weeks;\n   * Hypothyroidism managed by thyroid replacement;\n   * Alopecia;\n   * Arthritis managed without systemic therapy beyond oral nonsteroidal anti-inflammatory drugs.\n   * Adrenal insufficiency well controlled on replacement therapy.\n2. Major surgery or traumatic injury within 8 weeks before first dose of study drug.\n3. Unhealed wounds from surgery or injury.\n4. Treatment with \\>10 mg per day of prednisone (or equivalent) or other immune-suppressive drugs within 7 days prior to the initiation of study drug. Exceptions may be made for patients who have had allergic reaction to iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed.\n5. Prior therapy within the following timeframe before planned infusion of STAR0602 as follows:\n\n   * Cytotoxic chemotherapy, small molecule inhibitors, radiation, interventional radiology procedure, or similar investigational therapies within ≤ 2 weeks or participants who have not recovered (i.e., ≤ Grade 1 or to baseline) from AEs due to a previously administered agent;\n   * Monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or similar investigational therapies within 6 weeks prior to the initiation of study drug or participants who have not recovered (i.e., ≤ Grade 1 or to baseline) from AEs due to agents administered more than 4 weeks earlier. Note: Participants with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study.\n6. Clinically significant cardiovascular\u002Fvascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises\n7. Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug.\n8. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed.\n9. Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease.\n10. Second primary invasive malignancy not in remission for ≥ 1 year. Exceptions include non-melanoma locally advanced skin cancer, cervical carcinoma in situ, localized prostate cancer (Gleason score ≤ 7), resected melanoma in situ, or any malignancy considered to be indolent and never required systemic therapy, with the exception of indolent lymphomas.\n11. Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation).\n12. Hepatic metastases unless adequately treated, either locally (e.g., by surgery, radiofrequency ablation, or chemoembolization) or systemically or both, and stable for 3 months.\n13. Bulky disease defined as any lesion ≥ 5 cm in greatest dimension unless approved by the Sponsor.",{"count":233,"type":21},366,[24,58],"This is an open label, multicenter, phase 1\u002F2 study to assess the safety\u002Ftolerability and preliminary clinical activity of STAR0602 as a single agent and in combination with chemotherapy administered intravenously in participants with advanced solid tumors that are antigen-rich.",[27,237,238,239,240,241,242,243,244,245,246,247,33,167],"Genital Neoplasm, Female","Urogenital Neoplasms","Lung Neoplasm","Neoplasms by Site","Papillomavirus Infection","Epstein-Barr Virus Infections","Carcinoma","Neoplasms","Vulvar Neoplasms","Vulvar Diseases","Abdominal Neoplasm",[27,249,250,251,252,253,254,255,256,257,258,259,260,171,261,262,173,263,85,264,265,266,165,167,267,268,269,270,271,272],"STAR0602","Intravenous","Antineoplastic Agents","T Cell Receptor-targeting","Bifunctional Antibody-Fusion","Specific T Cell Activator","Tumor Mutational Burden (TMB) High","Microsatellite Instability (MSI) High","Virally Associated Malignancies","Checkpoint Inhibitor Resistance","Immunotherapy","Immune Checkpoint Inhibitor Resistance","Nasopharyngeal Cancer","Non-small Cell Lung Cancer","Biliary Cancer","Merkel Cell Carcinoma","Skin Squamous Cell Carcinoma","Skin Basal Cell Carcinoma","Small Bowel Cancer","Cervical Cancer","Gastrointestinal Neoplasms","Gastric Cancer","Esophageal Cancer","Bladder Cancer","2026-08-06",{"date":275,"type":39},"2026-08-11",{"date":277,"type":39},"2023-01-04",{"date":279,"type":21},"2027-09",{"name":281,"class":46},"Marengo Therapeutics, Inc.",19,{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":17,"minAge":290,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":22,"phases":293,"briefSummary":294,"conditions":295,"keywords":296,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":313},"100650977","oral-paclitaxel-solution-with-immunotherapy-and-concurrent-sbrt-as-neoadjuvant-treatment-for-older-adults-with-nsclc-100650977","NCT07754812","Oral Paclitaxel Solution With Immunotherapy and Concurrent SBRT as Neoadjuvant Treatment for Older Adults With NSCLC","A Multicenter, Open-Label, Single-Arm Phase I\u002FII Study of Oral Paclitaxel Solution Combined With an Immune Checkpoint Inhibitor and Concurrent Stereotactic Body Radiotherapy as Neoadjuvant Treatment in Older Patients With Resectable Stage IIA-IIIB Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Age 70 years or older, regardless of sex.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Histologically confirmed non-small cell lung cancer, clinical stage IIA-IIIB according to the 8th edition of the AJCC staging system.\n* No evidence of distant metastasis and considered suitable for radical lung cancer surgery.\n* The primary lung lesion is suitable for stereotactic body radiotherapy.\n* No sensitizing driver alterations in EGFR, ALK, ROS1, or other tested actionable genes.\n* Adequate major organ function, including all of the following:\n* Absolute neutrophil count at least 1.5 × 10\\^9\u002FL, platelet count at least 100 × 10\\^9\u002FL, and hemoglobin at least 9 g\u002FdL.\n* Total bilirubin no more than 1.5 × the upper limit of normal; alanine aminotransferase and aspartate aminotransferase no more than 2.5 × the upper limit of normal.\n* Serum creatinine no more than 1.5 × the upper limit of normal or creatinine clearance at least 60 mL\u002Fmin.\n* Urine protein less than 1+; if urine protein is 1+, 24-hour urine protein must be less than 500 mg.\n* Blood glucose within the normal range or stable glycemic control in participants with diabetes.\n* Baseline forced expiratory volume in 1 second (FEV1) at least 2 L; if FEV1 is less than 2 L, the predicted postoperative FEV1 must be greater than 800 mL as assessed by a thoracic surgeon.\n* No myocardial infarction within the previous year, no unstable angina, no symptomatic severe arrhythmia, and no cardiac insufficiency.\n* The participant has been fully informed and voluntarily provides written informed consent.\n\nExclusion Criteria:\n\n* Prior lobectomy, thoracic radiotherapy, or systemic antitumor therapy.\n* Another concurrent malignancy or a history of another malignancy cured less than 5 years before enrollment, except adequately treated cervical carcinoma in situ or basal cell or squamous cell carcinoma of the skin.\n* Active autoimmune disease or a history of autoimmune disease requiring systemic immunosuppressive treatment.\n* Active infection requiring systemic treatment, active tuberculosis, human immunodeficiency virus infection, active hepatitis B or hepatitis C, active syphilis, or another active transmissible infection specified by the protocol.\n* Severe cardiac, hepatic, renal, or metabolic disease that precludes surgery or study treatment.\n* History of interstitial lung disease or drug-induced pneumonitis, or imaging evidence of active interstitial lung disease.\n* Uncontrolled large pleural effusion or pericardial effusion.\n* Major surgery, severe trauma, or treatment with another investigational drug within 4 weeks before enrollment.\n* Recent receipt of an anticancer vaccine or live vaccine.\n* Any other condition that, in the investigator's opinion, makes the participant unsuitable for the study or may interfere with interpretation of the study results.","70 Years",{"count":292,"type":21},78,[124],"his multicenter, open-label, single-arm phase I\u002FII trial will evaluate the safety, tolerability, and preliminary efficacy of oral paclitaxel solution combined with an immune checkpoint inhibitor and concurrent stereotactic body radiotherapy (SBRT) as neoadjuvant therapy in patients aged 70 years or older with resectable stage IIA-IIIB non-small cell lung cancer (NSCLC) without sensitizing EGFR, ALK, or ROS1 alterations.\n\nIn Phase I, a 3+3 dose-escalation design will evaluate oral paclitaxel at 80, 120, and 160 mg\u002Fm² administered orally on Days 1 and 8 of each cycle, divided into morning and evening doses, in combination with an investigator-selected anti-PD-1 or anti-PD-L1 monoclonal antibody and SBRT at 8 Gy in 3 fractions. Phase II will expand enrollment at the recommended Phase II dose (RP2D). The principal efficacy outcome is pathologic complete response after surgery. Other outcomes include major pathologic response, radiographic response, event-free survival, overall survival, surgical resection and R0 resection rates, and exploratory biomarker changes.",[33],[297,298,299,300,301,302,303],"Elderly patients","Neoadjuvant therapy","Oral paclitaxel solution","Immune checkpoint inhibitor","SBRT","Resectable NSCLC","Pathologic complete response","2026-08-05",{"date":138,"type":39},{"date":307,"type":39},"2026-06-25",{"date":309,"type":21},"2028-10-31",{"name":311,"class":312},"Shanghai Pulmonary Hospital, Shanghai, China","OTHER",5,{"id":315,"slug":316,"hasResults":12,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":22,"phases":322,"briefSummary":324,"conditions":325,"keywords":327,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":332,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":339},"100643968","a-study-to-evaluate-gfh375-versus-docetaxel-in-participants-with-non-small-cell-lung-cancer-with-kras-g12d-mutation-100643968","NCT07668752","A Study to Evaluate GFH375 Versus Docetaxel in Participants With Non-Small Cell Lung Cancer With KRAS G12D Mutation","A Phase III, Randomized, Open-Label, Multicenter Study to Evaluate GFH375 Versus Docetaxel in Participants With Locally Advanced and Unresectable or Metastatic Non-Small Cell Lung Cancer With KRAS G12D Mutation Failed Prior Standard Therapy","Inclusion Criteria:\n\n* 1\\. Voluntary participation in the study and signed informed consent form (ICF).\n* 2\\. Age ≥ 18 years at the time of signing the ICF; male or female.\n* 3\\. Histologically or cytologically confirmed locally advanced unresectable or metastatic non small cell lung cancer (NSCLC).\n* 4\\. Participants must provide adequate and qualified tumor tissue slides samples or agree to undergo tumor biopsy to obtain tissue samples for central laboratory confirmation of KRAS G12D mutation.\n* 5\\. Disease progression or intolerance to toxicity after at least one prior line of platinum based chemotherapy and anti PD 1\u002FPD L1 antibody therapy.\n* 6\\. At least one measurable target lesion according to RECIST version 1.1.\n* 7\\. Investigator assessed life expectancy ≥ 12 weeks.\n* 8\\. Adequate organ function.\n* 9\\. Ability to communicate well, comply with scheduled follow up visits, and adhere to protocol requirements.\n\nExclusion Criteria:\n\n* 1\\. Presence of other driver gene mutations in NSCLC, or concurrent other KRAS or RAS mutations.\n* 2\\. Other malignancy that has progressed or required treatment within 3 years prior to randomization.\n* 3\\. Leptomeningeal metastasis, or symptomatic or progressive central nervous system (CNS) metastasis.\n* 4\\. Existing or potential severe bone injury due to bone metastasis, or uncontrolled pain related to bone metastasis.\n* 5\\. Prior treatment with KRAS G12D targeted therapy or pan RAS\u002FKRAS targeted therapy.\n* 6\\. Prior treatment with docetaxel as part of systemic therapy.\n* 7\\. Radiotherapy within 4 weeks prior to randomization, or other local anti tumor therapy within 4 weeks prior to randomization.\n* 8\\. Other anti tumor therapy within 28 days or 5 half lives prior to randomization, or cell therapy within 3 months prior to randomization.\n* 9\\. Clinically significant severe cardiovascular disease.\n* 10\\. Stroke or other severe cerebrovascular disease within 6 months prior to randomization.\n* 11\\. Major acute or chronic infectious disease.\n* 12\\. Other poorly controlled systemic diseases.\n* 13\\. Severe psychiatric or psychological disorder, or history of drug abuse, or severe alcohol abuse.\n* 14\\. Pregnancy or breastfeeding.\n* 15\\. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.",{"count":155,"type":21},[323],"PHASE3","The purpose of this study is to compare the effectiveness, safety and tolerability of GFH375 versus docetaxel in participants with KRAS G12D-mutant non-small cell lung cancer (NSCLC).\n\nGFH375 is an oral, highly selective, non-covalent small-molecule inhibitor targeting the KRAS G12D mutation. Preclinical studies showed GFH375 strongly blocks KRAS-driven signaling and cancer cell growth, and demonstrated anti-tumor activity in NSCLC animal models. Docetaxel is a chemotherapy drug for locally advanced or metastatic NSCLC.\n\nThis is an open-label, randomized controlled trial. Both participant and study doctor will know which study medication each participant receives.\n\nAfter enrollment, participant will be randomly assigned to either the GFH375 group or docetaxel group by chance. Neither participant nor study doctor can pick your treatment group. You have a two-thirds chance to receive GFH375 and a one-third chance to receive docetaxel.\n\n* GFH375 group: Take GFH375 tablets by mouth once daily as scheduled; each treatment cycle lasts 21 days.\n* Docetaxel group: Receive docetaxel via intravenous infusion at 75 mg\u002Fm² once every 3 weeks.\n\nStudy treatment will continue until cancer gets worse, participant can't tolerate the study treatment, or other conditions make participant unable to keep receiving study treatment.\n\nSome participants on docetaxel may be able to switch to GFH375 during the study if their cancer becomes worse. There will be safety checks at each visit, and the doctors will continue to check for medical problems and participant 's wellbeing throughout the study. Participants will continue to have scans of their tumor every 6 weeks for the first year, then every 9 weeks until their cancer becomes worse. After participant's cancer becomes worse, clinic staff will telephone participant every 3 mouths to check on their cancer.",[326,33],"KRAS G12D Mutation",[328,329,330,331],"GFH375","Docetaxel","Non-small cell lung cancer (NSCLC)","KRAS G12D",{"date":138,"type":39},{"date":334,"type":39},"2026-07-27",{"date":336,"type":21},"2031-04-30",{"name":338,"class":46},"Genfleet Therapeutics (Shanghai) Inc.",1,{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":346,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":22,"phases":350,"briefSummary":351,"conditions":352,"keywords":355,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":371},"100583857","phase-3-study-of-daraxonrasib-rmc-6236-in-patients-with-ras-mutated-nsclc-rasolve-301-100583857","NCT06881784","Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)","RASolve 301: Phase 3 Multicenter, Open Label, Randomized Study of RMC-6236 Versus Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic RAS[MUT] NSCLC","RASolve 301","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Pathologically confirmed NSCLC, either locally advanced or metastatic, not amenable to curative surgery or radiotherapy.\n* Measurable disease per RECIST v1.1.\n* Adequate organ function (bone marrow, liver, kidney, coagulation).\n* One to two prior lines of therapy including an anti-PD-1\u002Fanti-PD(L)-1 agent and platinum-based chemotherapy.\n* Documented RAS mutation status, defined as Nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Prior therapy with direct RAS-targeted therapy or docetaxel.\n* Untreated central nervous system (CNS) metastases.\n* Medically significant comorbidities (significant cardiovascular disease, lung disease, or impaired GI function).\n* Ongoing anticancer therapy.\n* Pregnant or breastfeeding.",{"count":349,"type":21},590,[323],"The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.",[33,88,176,353,354],"NSCLC (Non-small Cell Lung Carcinoma)","NSCLC (Advanced Non-small Cell Lung Cancer)",[176,88,163,356,357,358,359,360,361,362],"RAS","KRAS","HRAS","NRAS","RAS Q61 Mutation","RAS G12 Mutation","RAS G13 Mutation","2026-08-04",{"date":273,"type":39},{"date":366,"type":39},"2025-05-06",{"date":368,"type":21},"2030-12-01",{"name":370,"class":46},"Revolution Medicines, Inc.",152,{"id":373,"slug":374,"hasResults":12,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":378,"eligibilityCriteria":379,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":22,"phases":382,"briefSummary":384,"conditions":385,"keywords":396,"overallStatus":412,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":4},"100646600","a-multicenter-randomized-open-label-trial-evaluating-ctdna-guided-interruption-versus-standard-of-care-immune-checkpoint-inhibitor-ici-therapy-in-patients-with-advanced--metastatic-solid-tumors-100646600","NCT07689812","A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced \u002F Metastatic Solid Tumors.","A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Continuous Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced\u002FMetastatic Solid Tumors","SIGNAL-IO 301","Inclusion Criteria:\n\nGeneral inclusion criteria includes the following selection criteria to be eligible for inclusion in any aspect of the study. Eligibility will be assessed by the investigator:\n\n1. Signed Informed consent\n2. Age ≥ 18 years\n3. ECOG 0-2.\n4. Histologically confirmed advanced\u002Fmetastatic solid tumors including:\n\n   1. Melanoma: Unresectable recurrent, advanced, or metastatic\n   2. NSCLC: Advanced or metastatic\n   3. MSI-High\u002FdMMR CRC: Metastatic\n   4. RCC: Unresectable recurrent, advanced, or metastatic\n   5. Other: Metastatic solid tumors\n5. Received first line ICI monotherapy or dual-ICI therapy (e.g., PD-1\u002FCTLA-4 combination therapy) for a minimum of 12 months (maximum of 15 months) for NSCLC, RCC \\& other metastatic solid tumors, or for a minimum of 6 months (maximum of 9 months) for melanoma and MSI-High \u002FdMMR CRC. Exceptions permitted:\n\n   * For patients with NSCLC: First line platinum-based chemo-ICI regimens if on maintenance ICI +\u002F- pemetrexed.\n   * For patients with melanoma: nivolumab\u002Frelatlimab is permissible.\n6. Radiographic CR\u002FPR: Participants must have CR or PR at the last assessment performed within 6 weeks before randomization according to RECIST v1.1 using a diagnostic CT and\u002For MRI. Radiographic assessment must be confirmed by the BICR prior to randomization.\n7. Known ctDNA-negative with a tissue-informed assay\n\n   * ≥ 2 consecutive ctDNA-negative results at least 6 weeks apart; last test within 1 month of enrollment.\n   * Note: A confirmatory Signatera Genome negative test must be completed at enrollment if previous ctDNA testing performed for clinical care was done with a test other than Signatera Genome.\n8. Adequate organ function:\n\n   1. Hematology: ANC ≥1500\u002FμL; Platelets ≥100000\u002FμL;Hemoglobin ≥9.0g\u002FdL;\n   2. Renal: Serum Cr ≤1.5×ULN or calculated CrCl ≥60 mL\u002Fmin (using Cock-Gault formula);\n   3. Hepatic: Total bilirubin ≤1.5 ×ULN or, for participants with total bilirubin levels \\>1.5×ULN, direct bilirubin within normal limits; AST (SGOT) and ALT (SGPT) ≤2.5×ULN;\n   4. Coagulation: INR or PT, activated partial thromboplastin time (APTT) ≤1.5×ULN Note: Laboratory assessments performed as part of standard of care evaluations during immunotherapy treatment administration may be used to satisfy these eligibility criteria, provided they are obtained within 28 days of enrollment.\n9. Recovery to baseline or ≤ Grade 1 common terminology criteria for adverse events (CTCAE) v6 from AE(s) related to any prior treatments unless AE(s) are deemed clinically non-significant (e.g., Grade 2 alopecia) by the Investigator and\u002For stable on supportive therapy.\n10. No prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cancer, or has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since completion of definitive therapy\n11. Participants must be willing and able to comply with study visits, treatment plans, laboratory tests, and other study procedures\n12. Women of child-bearing potential (WOCBP) and male participants partnering with WOCBP must agree to use highly effective contraception during the treatment phase and at least 180 days post last dose\n13. Patients must be willing to discontinue clinically-directed ctDNA testing for treatment response monitoring during the period of clinical trial testing as dictated by the protocol.\n\nExclusion Criteria\n\nPatients are not eligible for the study if they meet any of the following criteria, as assessed by the investigator:\n\n1. Available alternate treatment options with curative intent, e.g. surgery and \u002F or RT and \u002F or Chemotherapy.\n2. Symptomatic or progressing CNS metastases; or presence of leptomeningeal disease.\n3. Patient has active autoimmune disease that required systemic treatment in the past 2 years, is immunocompromised in the opinion of the Investigator, or is receiving systemic immunosuppressive treatment. (Note: Participants with splenectomy are allowed.) Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment.\n4. Patient is receiving systemic steroid therapy ≤3 days prior to enrollment or receiving any other form of immunosuppressive medication with the exception of daily steroid replacement therapy. Note: Use of inhaled corticosteroids, local steroid injection, or steroid eye drops is allowed.\n5. Had allogeneic tissue\u002Fsolid organ transplantation.\n6. Interstitial lung disease or history of pneumonitis that has required oral or IV steroids. Note: Patients with lymphangitic carcinomatosis secondary to NSCLC can be considered as eligible.\n7. Has received or will receive a live vaccine within 30 days prior to enrollment (seasonal flu vaccines that do not contain live vaccine are permitted).\n8. Active infection requiring intravenous systemic therapy.\n9. Known history of human immunodeficiency virus (HIV).\n10. Known active Hepatitis B or C.\n11. Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n12. Currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of enrollment.\n13. Use of any commercial ctDNA or liquid biopsy monitoring outside of the study protocol during the treatment monitoring phase within the protocol.",{"count":381,"type":21},920,[383],"NA","This is a multicenter, open-label, randomized (1:1) trial designed to evaluate whether ctDNA-guided interruption of immune-checkpoint inhibitor (ICI) therapy provides comparable survival to standard of care (SoC) continuous ICI therapy in patients with histologically confirmed advanced\u002Fmetastatic non-small cell lung cancer (NSCLC), melanoma, microsatellite instability-high (MSI-High)\u002FDeficient Mismatch Repair (dMMR) colorectal cancer (CRC), renal cell carcinoma (RCC) and other solid tumors. This study will be conducted in up to 100 sites.",[354,33,353,176,386,387,388,389,390,391,392,393,394,27,395],"Melanoma (Skin Cancer)","Melanoma (Skin) Stage IV","CRC","MSI High Colorectal Cancer","DMMR Colorectal Cancer","RCC, Renal Cell Cancer","RCC","Solid Tumors","Metastatic Solid Tumors","Advanced Solid Tumors Cancer",[397,398,300,399,400,176,85,401,402,167,388,403,392,404,405,406,407,408,409,410,411],"ctDNA","Circulating tumor DNA","ICI","Non-small cell lung cancer","Microsatellite Instability-High\u002Fdeficient Mismatch Repair","MSI-High\u002FdMMR","Renal cell carcinoma","Metastatic solid tumors","Signatera","Molecular residual disease","MRD","Biomarker-guided therapy","Adjuvant therapy","Tumor-informed assay","Advanced solid tumor","NOT_YET_RECRUITING","2026-07-31",{"date":363,"type":39},{"date":416,"type":21},"2026-12",{"date":418,"type":21},"2034-03",{"name":420,"class":46},"Natera, Inc.",{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":4,"eligibilityCriteria":427,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":428,"targetDuration":4,"studyType":22,"phases":430,"briefSummary":431,"conditions":432,"keywords":437,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":339},"100650016","phase-2-targeted-induction-therapy-for-stage-iii-unresectable-egfr-mutant-positive-nsclc-100650016","NCT07742332","Targeted Induction Therapy for Stage III Unresectable EGFR Mutant Positive NSCLC","Targeted Induction Therapy for Stage III Unresectable EGFR Mutant Positive NSCLC: a Single-center, Randomized Controlled Trial","Inclusion Criteria:\n\n* NSCLC patient with EGFR sensitive mutation as confirmed by needle biopsy;\n* At stage II-IIIA (TNM Staging, Version 8) as identified by chest CT, PET-CT or\u002Fand EBUS;\n* No systemic metastasis (confirmed by head MRI, whole body bone scan, PET-CT, liver and adrenal CT, etc.);\n* With the feasibility to receive radical surgery ;\n* Good lung function that could tolerate surgical treatment;\n* Minimum age: 18 years;\n* At least one measurable tumor foci (the longest diameter measured by CT shall be \\> 10 mm);\n* Other major organs shall function well (liver, kidney, blood system, etc.):\n* ECOG PS score shall be 0-1;\n* The child-bearing female must undergo pregnancy test within 7 days before starting the treatment and the result shall be negative. Reliable contraceptive measures, such as intrauterine device, contraceptive pill and condom, shall be adopted during the trial and within 30 days after completion of the trial. The child-bearing male shall use condom for contraception during the trial and within 30 days after completion of the trial;\n* The patient shall sign the Informed Consent Form.\n\nExclusion Criteria:\n\n* The patient has undergone any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment, etc.;\n* The patient suffers from any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that starts to attack within the last 3 months, congestive heart failure \\[≥ Grade II specified by New York Heart Association (NYHA)\\], cardiac infarction (6 months before enrollment), severe arrhythmia and liver, kidney or metabolic diseases that requires drug treatment;\n* The patient is a carrier of HIV;\n* The patient has had or is currently suffering from interstitial lung disease;\n* The patient had undergone other major systemic operations or suffered from severe trauma within 3 months before the trial;\n* The patient is allergic to befotertinib or its any excipients;\n* The patient is allergic to bevacizumab or its any excipients;\n* The patient is allergic to platinum-based double chemotherapy or its any excipients;\n* The female patient is in pregnancy or lactation period;\n* There are any conditions under which the investigator considers the patient is not suitable to be enrolled.",{"count":429,"type":21},160,[58],"The subjects of this study are patients with unresectable stage III non-small cell lung cancer (NSCLC) who have EGFR mutations.",[433,33,434,435,436],"EGFR","Locally Advanced Non-Small Cell Lung Cancer","Radiotherapy","Chemotherapy",[436,433,438,439,434],"NSCLC (non-small cell lung cancer)","radiotherapy","2026-07-29",{"date":442,"type":39},"2026-08-03",{"date":444,"type":39},"2025-11-25",{"date":446,"type":21},"2032-11-25",{"name":448,"class":312},"Peng Zhang",{"id":450,"slug":451,"hasResults":12,"nctId":452,"briefTitle":453,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":22,"phases":457,"briefSummary":458,"conditions":459,"keywords":464,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":486},"100506384","phase-1-a-phase-1-clinical-study-of-nxp900-in-subjects-with-advanced-cancers-100506384","NCT05873686","A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers","Part A\n\nInclusion Criteria:\n\n1. Provide written informed consent.\n2. 18 years old or older.\n3. Advanced, metastatic, and\u002For progressive solid tumors for whom there is no authorized or effective therapy available, or for whom such therapies are considered inappropriate by the Investigator.\n4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n\nExclusion Criteria:\n\n1. Subjects with known human epidermal growth factor receptor 2 (HER2+) overexpressing malignancies.\n2. Radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy, or investigational agent within 28 days, (42 days for nitrosoureas, mitomycin-C) of first dose of NXP900. Subjects can continue to receive bisphosphonates due to metastatic bone disease or GnRH agonists if they have prostate cancer.\n3. Ongoing toxic manifestations of previous treatments \\> Grade 2 with the exception of alopecia and neuropathy.\n4. Subjects with treated brain metastases with evidence of progression within 28 days after central nervous system (CNS)-directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging \\[MRI\\] or computed tomography \\[CT\\] scan) during the Screening period.\n5. Female subjects who can become pregnant (or are already pregnant or lactating), unless they have a negative serum pregnancy test before enrollment and agree to use at least one highly effective form of contraception .\n6. Male subjects with partners of childbearing potential, unless they agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide).\n7. Major surgery from which the subject has not yet recovered.\n\nPart B:\n\nInclusion Criteria:\n\n1. Provide written informed consent.\n2. 18 years old or older.\n3. Advanced, metastatic, and\u002For progressive solid tumors with pathogenic molecular alterations:\n\n   1. Non-small cell lung cancer (adenocarcinoma); YES1, TYMS amplification or FAT1 pathogenic mutation\n   2. Non-small cell lung cancer (squamous cell carcinoma); YES1, TYMS amplification or FAT1 pathogenic mutation\n   3. Renal cancer; NF2 pathogenic mutation\n   4. Mesothelioma; NF2 pathogenic mutation\n   5. Other solid tumors with a NF2, FAT1 or LATS1 pathogenic gene mutation or TYMS, YAP1, YES1, or TAZ1 gene amplification, or cholangiocarcinoma with IDH1 or IDH2 mutations.\n4. Must have received 1-3 prior therapies appropriate for their tumor type and stage of disease\n5. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (or mRECIST 1.1 for subjects with pleural mesothelioma).\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n\nExclusion Criteria:\n\n1. Subjects with the following combination of cancer type and pathogenic molecular alterations are excluded:\n\n   1. Subjects with colorectal cancer, glioma, melanoma, or anaplastic thyroid conditions with BRAF mutations.\n   2. Subjects with NSCLC with BRAF or EGFR mutations or HER2 overexpression.\n   3. Subjects with breast cancer, gastric cancer, esophageal junction adenocarcinoma or biliary cancer with HER2 alterations,\n2. Subjects with anal, penile, cervical or head and neck cancers with a prior history of human papilloma virus (HPV) infection.\n3. Radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy, or investigational agent within 28 days (42 days for nitrosoureas, mitomycin-C) prior to first dose of NXP900. Subjects can continue to receive bisphosphonates due to metastatic bone disease or GnRH agonists if they have prostate cancer.\n4. Ongoing toxic manifestations of previous treatments \\> Grade 2 with the exception of alopecia and neuropathy.\n5. Female subjects who can become pregnant (or are already pregnant or lactating), unless they have a negative serum pregnancy test before enrollment and agree to use at least one highly effective form of contraception .\n6. Male subjects with partners of childbearing potential, unless they agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide).\n7. Major surgery from which the subject has not yet recovered.",{"count":456,"type":21},140,[24],"This is a multi-center, first-in-human, open label, dose escalation (Part A) and expansion (Part B) Phase 1 study in subjects with advanced solid tumors and in subjects with solid tumors with selected genetic alterations that are either direct (YES1 amplification) or dependent (Hippo Pathway alterations) targets of NXP900.",[159,33,460,461,462,463],"Renal Cancer","Mesothelioma","Non-Small Cell Squamous Lung Cancer","Non-small Cell Lung Adenocarcinoma",[61,243,244,465,466,467,468,469,470,471,472,473,474,475,476],"Adenocarcinoma","YES1","YAP1","TAZ1","NF2","FAT1","LATS1","TYMS","gene amplification","gene mutation","IDH1","IDH2","2026-07-07",{"date":479,"type":39},"2026-07-09",{"date":481,"type":39},"2023-10-26",{"date":483,"type":21},"2027-07",{"name":485,"class":46},"Nuvectis Pharma, Inc.",15,{"id":488,"slug":489,"hasResults":12,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":4,"eligibilityCriteria":493,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":494,"targetDuration":4,"studyType":22,"phases":496,"briefSummary":497,"conditions":498,"keywords":511,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":521},"100628495","phase-1-a-phase-1-study-of-epi-326-in-egfr-mutant-nsclc-and-hnscc-100628495","NCT07462377","A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC","A First-in-Human, Open-label, Multicenter, Phase 1 Study of EPI-326 in Patients With Epidermal Growth Factor Receptor-Mutant Non-small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Participant has a life expectancy \\> 12 weeks at Day 1.\n2. Participant has an ECOG performance status of 0-2.\n3. Participant has pathologically confirmed NSCLC or HNSCC.\n\n   o For NSCLC: the tumor harbors any documented EGFR mutation, insertion, or deletion.\n4. Participant has locally advanced or metastatic NSCLC or HNSCC.\n5. Participant has adequate organ function\n\nExclusion Criteria:\n\n1. Participant has history of uncontrolled illness.\n2. Participant has symptomatic brain metastases.\n3. Participant has a diagnosis of any secondary malignancy within 3 years prior to enrollment, except for those patients treated with curative intent and no evidence of active disease.",{"count":495,"type":21},110,[24],"A phase 1 study to determine the safety, tolerability, PK, PD, and preliminary anti-tumor activity of ascending doses of EPI-326 administered to patients with locally advanced or metastatic HNSCC and to patients with any documented EGFR-mutant locally advanced or metastatic NSCLC.",[499,500,501,502,503,504,505,171,506,507,508,509,33,510,433],"Epidermal Growth Factor","Epidermal Growth Factor Receptor","Epidermal Growth Factor Receptor Gene Mutation","Non Small Cell","Non Small Cell Lung","Non Small Cell Lung Cancer","Head and Neck","Head and Neck Cancers","Head and Neck Squamous Cell Cancer","Head and Neck Squamous Cell Carcinoma","Head and Neck Squamous Cell Carcinoma HNSCC","HNSCC",[508,510,501,433,504,176],"2026-07-01",{"date":514,"type":39},"2026-07-06",{"date":516,"type":39},"2026-03-31",{"date":518,"type":21},"2029-07",{"name":520,"class":46},"EpiBiologics",6,{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":529,"enrollmentInfo":530,"targetDuration":4,"studyType":22,"phases":531,"briefSummary":532,"conditions":533,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":339},"100637847","phase-2-hypofractionated-chemoradiotherapy-with-tislelizumab-and-surufatinib-for-unresectable-stage-iii-nsclc-100637847","NCT07609121","Hypofractionated Chemoradiotherapy With Tislelizumab and Surufatinib for Unresectable Stage III NSCLC","A Randomized Phase 2 Study of Hypofractionated Concurrent Chemoradiotherapy Combined With Tislelizumab and Surufatinib in Patients With Unresectable Stage III Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Males or females aged 18 to 75 years or older;\n* Patients must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC);\n* Unresectable Stage III disease according to AJCC 8th staging system;\n* Negative for known driver gene mutations；\n* Newly diagnosed patients or patients treated with ≤ 4 cycles of chemotherapy combined with or without immunotherapy;\n* Expected survival ≥ 12 weeks;\n* WHO Performance Status (PS) score of 0 or 1;\n* Female subjects must not be breastfeeding;\n* Women of childbearing potential (WOCBP) must agree to use contraception during the study treatment and for 5 months after the last dose of study drug (i.e., 30 days \\[one ovulation cycle\\] plus approximately five half-lives of the study drug);\n* Adequate organ and bone marrow function as defined by the following criteria:\n* Forced Expiratory Volume in 1 second (FEV1) ≥ 800 mL;\n* Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL;\n* Platelets ≥ 100 × 10⁹\u002FL;\n* Hemoglobin ≥ 9.0 g\u002FdL;\n* Creatinine clearance ≥ 50 mL\u002Fmin as calculated by the Cockcroft-Gault formula (Cockcroft and Gault, 1976);\n* Serum bilirubin ≤ 1.5 × upper limit of normal (ULN);\n* AST and ALT ≤ 2.5 × ULN.\n\nExclusion Criteria:\n\n* Concurrent enrolment in another clinical study, unless it is an observational(non-interventional) clinical study;\n* Mixed small cell and non-small cell lung cancer histology;\n* Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access;\n* Active or prior documented autoimmune disease within the past 2 years;\n* Active or prior documented inflammatory bowel disease (eg. Crohn's disease, ulcerative colitis);\n* History of primary immunodeficiency;\n* History of organ transplant that requires therapeutic immunosuppression;\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent;\n* Known history of tuberculosis;\n* History of another primary malignancy within 5 years prior to starting treatment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study;\n* Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control.","75 Years",{"count":429,"type":21},[58],"This phase II trial employs a prospective, randomized, parallel-group design to evaluate the efficacy and safety of hypofractionated radiotherapy combined with tislelizumab and surufatinib. Eligible patients are randomly assigned to one of two arms: Experimental Group A receives hypofractionated chemoradiotherapy plus concurrent tislelizumab and surufatinib, followed by consolidation therapy with tislelizumab plus surufatinib; Experimental Group B receives the same hypofractionated chemoradiotherapy plus concurrent tislelizumab alone, followed by tislelizumab consolidation.",[33],"2026-06-29",{"date":512,"type":39},{"date":537,"type":39},"2026-06-01",{"date":539,"type":21},"2029-05-31",{"name":541,"class":312},"Sun Yat-sen University",{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":548,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":550,"targetDuration":4,"studyType":552,"phases":4,"briefSummary":553,"conditions":554,"keywords":562,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":571,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":71},"100618120","predicting-response-to-immunotherapy-from-analysis-of-live-tumor-biopsies-elephas-05-100618120","NCT07327489","Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies (ELEPHAS-05)","Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies","ELEPHAS-05","Inclusion Criteria:\n\n1. Able and willing to provide informed consent for participation\n2. Age ≥18 years at time of consent.\n3. Have a suspected or confirmed cancer diagnosis that is to be evaluated by means of a biopsy.\n4. Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy. All other subjects should have the biopsy performed before starting their next line of treatment.\n\nExclusion Criteria:\n\n1. Have a known auto-immune disease or prior condition (prior organ transplant, chronic kidney or liver disease) that renders them ineligible for immunotherapy (IO) treatment.\n2. Severely immunocompromised person(s). Examples include patients on immunosuppressants, HIV positive patients on antiretrovirals, post transplantation patients.\n3. Pregnant person(s).",{"count":551,"type":21},2000,"OBSERVATIONAL","This study will collect tumor specimens with correlated clinical and demographic data from patients who are undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up for suspected or confirmed cancer.",[555,259,395,272,556,167,390,557,165,171,558,559,560,561,386],"Cancer","TNBC, Triple Negative Breast Cancer","MSI-H Colorectal Cancer","Kidney Cancer","Liver Cancer","NSCLC (Non-small-cell Lung Cancer)","Skin Cancer",[259,563,564,555,565,566,567,568,569,570],"Live Tumor Biopsy","Elephas","Imaging","Tumor Cutting","Treatment Response","Core Needle Biopsy","Forceps Biopsy","Punch Biopsy",{"date":534,"type":39},{"date":573,"type":39},"2025-04-14",{"date":575,"type":21},"2038-04",{"name":564,"class":46},{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":583,"eligibilityCriteria":584,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":585,"targetDuration":4,"studyType":22,"phases":586,"briefSummary":587,"conditions":588,"keywords":589,"overallStatus":412,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":339},"100641208","bright-light-therapy-in-patients-with-melanoma-or-non-small-cell-lung-cancer-nsclc-who-are-receiving-first-line-immune-checkpoint-blockade-100641208","NCT07661966","Bright Light Therapy in Patients With Melanoma or Non-small Cell Lung Cancer (NSCLC) Who Are Receiving First-Line Immune Checkpoint Blockade","A Pilot Trial of Bright Light Therapy in Patients Receiving First Line Immune Checkpoint Blockade","IIT BLT","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Histologically confirmed diagnosis of advanced, unresectable melanoma or NSCLC.\n3. Presence of measurable tumor burden.\n4. Scheduled to receive first-line cancer-directed therapy with an immune checkpoint blockade-containing regimen, as monotherapy or combination (e.g. pembrolizumab, ipilimumab + nivolumab, ICB + chemotherapy).\n5. ECOG performance status 0-2.\n6. Able to provide informed consent.\n7. Access to reliable internet connection via WiFi or personal hotspot\n\nExclusion Criteria:\n\n1. Previous exposure to immune checkpoint blockade.\n2. Pregnant or breastfeeding.\n3. Use of melatonin or pharmacologic sleep aids (e.g., zolpidem, trazodone, benzodiazepines) within 14 days prior to enrollment.\n4. Diagnosis of bipolar disorder or history of mania or hypomania.\n5. Active psychosis, suicidal ideation, or recent psychiatric hospitalization (\\\u003C3 months).\n6. Poorly controlled seizures.\n7. Chronotype classified as extremely early or extremely late, based on the Munich Chronotype Questionnaire (MSFsc \\\u003C 2:00 or \\> 5:00).\n8. Night shift work within the past 30 days or expected during the intervention.\n9. Travel across ≥2 time zones within the past 14 days.\n10. Diagnosed or suspected untreated moderate to severe obstructive sleep apnea.\n11. Migraine with photophobia.\n12. Presence of ocular or photosensitivity conditions affecting vision (i.e. advanced bilateral cataracts not yet operated, advanced glaucoma with substantial visual field loss, optic nerve disease, ocular surgery within the past 3 months with unresolved visual symptoms, color blindness).",{"count":122,"type":21},[383],"This study is being done to test whether bright light therapy can be used to synchronize patients' circadian rhythms and allow ICB (immune-checkpoint blockade) therapy to be administered at a time in the circadian rhythm that optimizes clinical outcomes. This trial will test the feasibility of delivering bright light therapy (BLT) to patients undergoing ICB therapy.\n\nThis trial asks participants to spend 60 minutes every morning receiving daily bright light therapy for at least 7 days prior to starting Immune Checkpoint blockade-containing regimens (e.g. anti-PD-1 and\u002For anti-CTLA-4 alone or in combination with chemotherapy). The bright light therapy will be delivered via the Circadian OS iPad application.\n\nThere is evidence that a person's circadian rhythm can affect the response to immunotherapy. The circadian rhythm is a natural, internal process that regulates the sleep-wake cycle. Many patients with cancer have disrupted circadian rhythms and it's possible that disrupted circadian rhythms decrease the likelihood of responding to immunotherapy.\n\nThe idea is to use bright light therapy, delivered via the Circadian OS iPad application, for an hour in the morning to synchronize your circadian rhythm for a week before your planned immunotherapy. The investigators hope that this will increase the likelihood of a response to immunotherapy, however in this study, the investigators are mainly concerned with whether the bright light therapy is tolerable to patients.",[386,33],[583,590,591,592],"Bright Light Therapy","Circadian","Circadian Rhythm","2026-06-23",{"date":595,"type":39},"2026-06-26",{"date":597,"type":21},"2026-06",{"date":599,"type":21},"2027-12",{"name":601,"class":312},"Weill Medical College of Cornell University",{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":607,"acronym":4,"eligibilityCriteria":608,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":609,"targetDuration":4,"studyType":22,"phases":611,"briefSummary":612,"conditions":613,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":618,"lastUpdatePostDateStruct":619,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":625,"locationsCount":627},"100557993","phase-1-study-of-xb010-in-subjects-with-solid-tumors-100557993","NCT06545331","Study of XB010 in Subjects With Solid Tumors","A Dose-Escalation and Expansion Study of XB010 as a Single Agent and Combination Therapy in Subjects With Locally Advanced or Metastatic Solid Tumors","* Age 18 years or older on the day of consent.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.\n* Adequate organ and marrow function.\n* Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent.\n\n  * The Cohort Expansion stage will enroll subjects with multiple tumor types (non-small cell lung cancer, hormone-receptor-positive breast cancer, head and neck cancer, esophageal squamous cell, triple-negative breast cancer).\n* Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.",{"count":610,"type":21},396,[24],"This is a FIH study is to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of XB010 as a single agent and in combination with pembrolizumab in subjects with locally advanced or metastatic solid tumors for whom alternative therapies do not exist or available therapies are intolerable or no longer effective.",[614,615,507,33,616,617],"Locally Advanced or Metastatic Solid Tumors","Esophageal Squamous Cell Cancer","Hormone-receptor-positive Breast Cancer","Triple Negative Breast Cancer (TNBC)","2026-06-17",{"date":620,"type":39},"2026-06-22",{"date":622,"type":39},"2024-08-06",{"date":624,"type":21},"2027-10-20",{"name":626,"class":46},"Exelixis",20,{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":633,"acronym":4,"eligibilityCriteria":634,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":635,"targetDuration":4,"studyType":22,"phases":637,"briefSummary":638,"conditions":639,"keywords":642,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":661,"lastUpdatePostDateStruct":662,"startDateStruct":664,"completionDateStruct":666,"leadSponsor":668,"locationsCount":122},"100580305","phase-1-a-study-to-learn-about-study-medicine-alta3263-in-adults-with-advanced-solid-tumors-with-kras-mutations-100580305","NCT06835569","A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations","A Phase 1\u002F1b Multiple Cohort Trial of ALTA3263 in Patients With Advanced Solid Tumors With KRAS Mutations","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of a solid tumor malignancy harboring a KRAS mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic test.\n* Unresectable or metastatic disease.\n* Progressed on, intolerant to, or declined prior standard-of-care therapy (including targeted therapy, if applicable) appropriate to tumor type and stage\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ function\n\nExclusion Criteria:\n\n* Prior treatment with a KRAS inhibitor, certain exceptions are described in the full study protocol\n* Known condition that prohibits the ability to swallow or absorb an oral medication.\n\nOther inclusion\u002Fexclusion criteria may apply.",{"count":636,"type":21},448,[24],"The purpose of this study is to characterize the safety and tolerability of ALTA3263 in adults with advanced solid tumors with KRAS mutations.",[555,640,33,641,27],"PDAC - Pancreatic Ductal Adenocarcinoma","CRC (Colorectal Cancer)",[643,176,400,644,645,646,647,648,649,357,650,651,652,244,240,243,653,654,655,656,657,658,659,660],"KRAS mutation","Colorectal cancer","Pancreatic ductal adenocarcinoma","Colorectal carcinoma","Pancreatic cancer","Pancreatic carcinoma","Solid tumors","Mutation","Metastatic","Advanced unresectable","Non-small cell lung carcinoma","Non-small cell lung neoplasm","Pancreatic neoplasm","Lung neoplasm","Colorectal neoplasm","Colon neoplasm","Mutant KRAS","KRAS amplification","2026-06-08",{"date":663,"type":39},"2026-06-10",{"date":665,"type":39},"2025-03-05",{"date":667,"type":21},"2029-08",{"name":669,"class":46},"Alterome Therapeutics, Inc.",{"id":671,"slug":672,"hasResults":12,"nctId":673,"briefTitle":674,"officialTitle":675,"acronym":4,"eligibilityCriteria":676,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":677,"targetDuration":4,"studyType":22,"phases":679,"briefSummary":680,"conditions":681,"keywords":693,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":705,"lastUpdatePostDateStruct":706,"startDateStruct":708,"completionDateStruct":710,"leadSponsor":712,"locationsCount":5},"100535595","phase-1-a-phase-11b-study-of-iam1363-in-her2-cancers-100535595","NCT06253871","A Phase 1\u002F1b Study of IAM1363 in HER2 Cancers","A Phase 1\u002F1b Study of IAM1363 in Participants With Advanced Cancers Harboring HER2 Alterations","Key Inclusion Criteria:\n\n* Age ≥ 18 years\n* Have relapsed\u002Frefractory HER2-altered malignancy; for selected cohorts, prospective confirmation of HER2 alteration by central testing is required\n* Have progression of disease after the last systemic therapy, or be intolerant of last systemic therapy\n* Have radiographically measurable disease by RECIST v1.1 and\u002For RANO-BM\n* Eastern Cooperative Oncology Group (ECOG) performance score 0-1\n* Have adequate baseline hematologic, liver and renal function\n* Have left ventricular ejection fraction (LVEF) ≥ 50%\n* Able to swallow oral medication\n\nKey Exclusion Criteria:\n\n* Clinically significant cardiac disease\n* Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: Participants with well-controlled HIV (e.g., CD4 \\>350\u002Fmm3 and undetectable viral load) are eligible\n* Current active liver disease including hepatitis A, hepatitis B , or hepatitis C\n* Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption\n* Uncontrolled diabetes\n* History of solid organ transplantation\n* History of Grade ≥2 CNS hemorrhage, or any CNS hemorrhage within 28 days before C1D1\n* Prior history of non-infectious interstitial lung disease (ILD). (Exceptions: participants with prior grade 1 ILD that has completely resolved are eligible)\n* Participants requiring immediate local therapy for brain metastases",{"count":678,"type":21},383,[24],"This is a Phase 1\u002F1b open-label, multi-center dose escalation and dose optimization study designed to evaluate the safety and preliminary efficacy of IAM1363 in participants with advanced cancers that harbor HER2 alterations.",[682,683,184,684,685,686,687,688,33,689,690,691,692],"HER2 Mutation-Related Tumors","HER2","HER2 + Breast Cancer","Brain Metastases From Solid Tumors","Brain Metastases From HER2 and Breast Cancer","CNS Metastases","HER2-Positive Solid Tumors","HER2-positive Bladder Cancer","HER2-positive Colorectal Cancer","HER2 + Gastric Cancer","HER2-positive Gastroesophageal Cancer",[694,695,696,697,698,699,700,701,702,703,683,704],"ERBB2 protein, human","Molecular Targeted Therapy","Genes, erbB-2","Receptor, ErbB-2 \u002F antagonists & inhibitors","Neoplasms \u002F drug therapy","HER2 positive","HER2 overexpressing","HER2 altered","Human epidermal growth factor receptor","ErbB Receptors","brain metastases","2026-06-02",{"date":707,"type":39},"2026-06-04",{"date":709,"type":39},"2024-03-25",{"date":711,"type":21},"2028-12",{"name":713,"class":46},"Iambic Therapeutics, Inc",{"id":715,"slug":716,"hasResults":12,"nctId":717,"briefTitle":718,"officialTitle":719,"acronym":4,"eligibilityCriteria":720,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":721,"targetDuration":4,"studyType":22,"phases":723,"briefSummary":724,"conditions":725,"keywords":728,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":742,"startDateStruct":743,"completionDateStruct":745,"leadSponsor":747,"locationsCount":749},"100497019","phase-1-dose-finding-and-dose-expansion-study-of-ose-279-in-subjects-with-advanced-solid-tumors-or-lymphomas-100497019","NCT05751798","Dose-finding and Dose Expansion Study of OSE-279 in Subjects With Advanced Solid Tumors or Lymphomas","A Multicenter, Phase 1\u002F2, Dose-finding and Dose Expansion Study of OSE-279, a PD-1 Blocking Monoclonal Antibody, in Subjects With Advanced Solid Tumors or Lymphomas","Parts B and C - INCLUSION CRITERIA\n\n1. Male or female, aged ≥ 18 years\n2. Signed and dated informed consent form (ICF) prior to any trialspecific procedures.\n3. ECOG performance status 0-1\n4. Patients must be affiliated to a social security system or an equivalent system, if applicable as per local regulations.\n5. Patients expressing HLA-A2 phenotype on blood sample performed by an experienced laboratory using a validated test (PCR or NGS). Additional patients HLA-A2 negative will be included in PART C.\n6. Tumor type: a) Histologically or cytologically documented Stage IV squamous or non-squamous NSCLC not eligible for definite surgery or radiation, without EGFR sensitizing mutation or ALK and ROS1 gene alterations eligible for targeted therapy or other mutations for which an approved therapy exists in 1st line metastatic (see protocol); b) PD-L1 expression by TPS ≥ 50% (local)\n7. Patients with NO prior systemic therapy including immunotherapy in the first-line metastatic setting. In case of neoadjuvant\u002Fadjuvant therapy, therapy was completed at least 6 months prior to the diagnosis of metastatic disease.\n8. Patients with at least one measurable lesion according to RECIST v1.1.\n9. Adequate organ function:\n\n   1. Bone marrow: neutrophils ≥ 1.5 x 109\u002FL, hemoglobin ≥ 90 g\u002FL, platelets ≥ 100 x 109\u002FL\n   2. Renal function: serum creatinine ≤ 1.5 ULN or CKDEPI creatinine clearance ≥ 30 mL\u002Fmin\n   3. Liver function: AST and ALT ≤ 3 ULN, bilirubin ≤ 1.5 ULN. In case of liver metastasis: AST and ALT ≤ 5 ULN. For patients with Gilbert's syndrome total bilirubin ≤ 3 ULN or direct bilirubin ≤ 1.5 ULN.\n\nParts B and C - NON-INCLUSION CRITERIA\n\n1. Patient eligible to surgical resection or another approved therapeutic regimen known to provide clinical benefit; Known hypersensitivity to the active substances or to any of the excipients of OSE2101 or docetaxel.\n2. Patient previously treated with approved\u002Finvestigational anti-PD-1\u002FPD-L1\n3. Patient with active autoimmune disease or a documented history of autoimmune disease requiring systemic treatment (i.e., corticosteroids or immunosuppressive drugs); see exceptions in protocol\n4. Patient participating in another clinical trial with a medicinal product\n5. Patients who have not recovered from AEs (i.e. \\> G1 according to CTCAE v5.0) due to prior treatment with anti-cancer agents with exception of G2 neuropathy or any Grade alopecia. (see protocol)\n6. Patients with known additional malignancy progressing or requiring active treatment. Basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer are not non-inclusion criteria\n7. Patients with known active central nervous system metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to C1D1 and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids (at doses \\> 10 mg\u002Fday methylprednisolone or equivalent) for 4 weeks prior C1D1\n8. Patients with active or history of non-infectious pneumonitis requiring steroids, or interstitial lung disease\n9. Patients with a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the duration of the study\n10. Patients with a history of uncontrolled or symptomatic, clinically significant cardiovascular disease: stroke, myocardial infarction, angina pectoris, arrhythmias, congestive heart failure (NYHA Class \\>2), or myocarditis within 6 months prior to first study drug administration",{"count":722,"type":21},41,[24,58],"This is a phase 1\u002F2, multicenter, dose-finding and dose expansion study of OSE-279, a PD-1 blocking monoclonal antibody, in subjects with advanced solid tumors or lymphomas.",[726,727,33],"Solid Advanced Tumor","Lymphoma",[729,727,730,731,732,438,733,734,735,736,737,738,739,740,741],"Solid advanced tumor","Rare tumor","PD-L1 positive tumor","PD-1 blocking monoclonal antibody","Cancer vaccine","Immune check point inhibitor","TEDOPI","OSE2101","OSE-2101","OSE 2101","OSE-279","OSE 279","HLA-A2",{"date":707,"type":39},{"date":744,"type":39},"2022-12-20",{"date":746,"type":21},"2029-12",{"name":748,"class":46},"OSE Immunotherapeutics",11,{"id":751,"slug":752,"hasResults":12,"nctId":753,"briefTitle":754,"officialTitle":755,"acronym":4,"eligibilityCriteria":756,"healthyVolunteers":12,"sex":17,"minAge":757,"maxAge":4,"enrollmentInfo":758,"targetDuration":4,"studyType":22,"phases":760,"briefSummary":761,"conditions":762,"keywords":763,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":767,"lastUpdatePostDateStruct":768,"startDateStruct":770,"completionDateStruct":771,"leadSponsor":773,"locationsCount":339},"100637853","phase-2-serplulimab-monotherapy-in-elderly-patients-with-nsclc-and-pd-l1-tps--50-100637853","NCT07596121","Serplulimab Monotherapy in Elderly Patients With NSCLC and PD-L1 TPS ≥ 50%","Multicenter, Single-arm, Phase II Exploratory Study of Serplulimab Monotherapy in Elderly Patients With NSCLC and PD-L1 TPS ≥ 50%","Inclusion Criteria:\n\n* 1.Voluntary participation and informed consent: Subjects must voluntarily join the study, sign the written informed consent form (ICF), and demonstrate good compliance.\n\n  2.Age and Gender: Aged ≥65 years at the time of signing the ICF, regardless of gender.\n\n  3.Diagnosis and Staging: Histologically or cytologically confirmed Stage IIIB (ineligible for definitive chemoradiotherapy), Stage IIIC, or Stage IV NSCLC according to the AJCC 8th edition staging system.\n\n  4.PD-L1 Expression: Tumor tissue confirmed as PD-L1 TPS≥50% by a central laboratory or a validated local laboratory, using SP263 or 22C3 assays (a formal test report must be provided).\n\n  5.Driver Gene Status: Known absence of actionable driver mutations, including but not limited to EGFR sensitive mutations, ALK fusions, and ROS1 fusions.\n\n  6.Measurable Disease: At least one measurable target lesion per RECIST v1.1 criteria (lesions must not have received prior radiotherapy).\n\n  7.Prior Treatment History: No prior systemic therapy for advanced or metastatic disease. For patients who received adjuvant or neoadjuvant chemotherapy, inclusion is permitted if disease recurrence occurred ≥6 months after the completion of the last dose.\n\n  8.Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2.\n\n  9.Adequate organ and bone marrow function (no blood transfusions or hematopoietic stimulating factor therapy within 14 days prior to the first dose):\n  * Absolute Neutrophil Count (ANC)≥1.5 x 10\\^9\u002F\u002FL\n  * Platelet Count (PLT)≥100 x 10\\^9\u002F\u002FL\n  * Hemoglobin (Hb)≥90 g\u002FL\n  * Serum Creatinine (Cr) ≤ 1.5 x Limit of Normal (ULN) or Creatinine Clearance ≥ 50mL\u002Fmin\n  * Total Bilirubin (TBIL) ≤ 1.5 x ULN\n  * Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT)≤ 2.5 x ULN(≤ 5 x ULN for patients with liver metastases)\n\nExclusion Criteria:\n\n* 1\\. Hypersensitivity: Known hypersensitivity to serplulimab or any of its excipients.\n\n  2\\. Prior Immunotherapy: Prior treatment with any anti-PD-1, anti-PD-L1, anti-CTLA-4, or other immune checkpoint inhibitors (ICIs).\n\n  3\\. Autoimmune Disease: Active autoimmune disease requiring systemic treatment (e.g., corticosteroids or immunosuppressants) within the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is permitted.\n\n  4\\. Lung Disease\u002FPneumonitis: Active interstitial lung disease (ILD) or pneumonitis, or a history of (non-infectious) pneumonitis requiring steroid treatment.\n\n  5\\. Infections: Active infection requiring systemic therapy. 6. CNS Metastases: Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. However, patients with treated (via surgery or radiotherapy) and stable brain metastases are eligible, provided they are radiographically stable for at least 4 weeks prior to the first dose, have no evidence of new or enlarged brain lesions, and have discontinued glucocorticoids for at least 14 days.\n\n  7\\. Pregnancy and Breastfeeding: Pregnant or breastfeeding women. 8. Investigator Discretion: Any other condition that, in the investigator's opinion, may interfere with the evaluation of the study drug, jeopardize subject safety, or confound the interpretation of study results.","65 Years",{"count":759,"type":21},60,[58],"This prospective clinical study aims to evaluate and observe the efficacy and safety of Serplulimab Monotherapy in Elderly Patients with NSCLC and PD-L1 TPS ≥ 50% using a multicenter, single-arm, phase II design.\n\nThe study is planned to be conducted in Shaanxi Province, China, with an initial target enrollment of 60 patients. The study commenced in May 2026, and recruitment is expected to conclude around May 2026, with the trial anticipated to end by May 2027.\n\nAssuming no occurrences such as withdrawal of informed consent by subjects, intolerable adverse drug reactions, or investigator-assessed unsuitability for further participation, each participant's estimated duration of study treatment will continue until radiographically confirmed tumor progression.",[33],[176,764,765,766],"Serplulimab","PD-L1 TPS≥50%","Monotherapy","2026-05-13",{"date":769,"type":39},"2026-05-19",{"date":767,"type":39},{"date":772,"type":21},"2027-05-31",{"name":774,"class":312},"Tang-Du Hospital",{"id":776,"slug":777,"hasResults":12,"nctId":778,"briefTitle":779,"officialTitle":780,"acronym":4,"eligibilityCriteria":781,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":782,"targetDuration":4,"studyType":22,"phases":783,"briefSummary":784,"conditions":785,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":786,"lastUpdatePostDateStruct":787,"startDateStruct":789,"completionDateStruct":791,"leadSponsor":793,"locationsCount":339},"100633560","phase-2-microwave-ablation-plus-tislelizumab-and-docetaxel-in-advanced-nsclc-after-first-line-immunotherapy-failure-100633560","NCT07528274","Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure","Microwave Ablation in Combination With Tislelizumab and Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer After Progression Following First-Line Immunotherapy Plus Chemotherapy: A Prospective, Single-Arm, Phase II Study","Inclusion Criteria:\n\n* Patients with cytologically or histologically confirmed non-small cell lung cancer (NSCLC), classified as stage IIIB, IIIC, or IV (AJCC 9th edition) and not eligible for curative treatment.\n* Male or female patients aged ≥18 years who have provided written informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, with an expected survival of more than 6 months, and deemed suitable for microwave ablation by the investigator.\n* Patients must have previously received first-line treatment with tislelizumab in combination with chemotherapy and have documented disease progression based on imaging assessments prior to enrollment. Disease progression must occur ≥6 months after initiation of first-line tislelizumab plus chemotherapy, with or without concomitant anti-angiogenic therapy.\n* Adequate organ and bone marrow function, defined as follows:\n\nAbsolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL Platelet count ≥100 × 10⁹\u002FL Hemoglobin ≥90 g\u002FL White blood cell count ≥3.0 × 10⁹\u002FL\n\nHepatic function:\n\nTotal bilirubin \\\u003C1.5 × the upper limit of normal (ULN) Aspartate aminotransferase (AST\u002FSGOT), alanine aminotransferase (ALT\u002FSGPT), and alkaline phosphatase (ALP) ≤2.5 × ULN In patients with liver metastases: AST and ALT ≤5.0 × ULN In patients with liver and\u002For bone metastases: ALP ≤5.0 × ULN\n\nRenal function:\n\nSerum creatinine ≤1.5 × ULN Urine protein \\\u003C2+ on urinalysis; if baseline urine protein is ≥2+, a 24-hour urine protein ≤1.0 g is required\n\nCoagulation function:\n\nInternational normalized ratio (INR) ≤1.5 Activated partial thromboplastin time (aPTT) ≤1.5 × ULN\n\n* Cardiac function defined as left ventricular ejection fraction (LVEF) ≥50%.\n* Ability to communicate effectively with the investigator and to comply with study-related visits, treatment, laboratory tests, and other study requirements.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded from the study:\n\n* Diagnosis of small cell lung cancer (SCLC), including mixed small cell and non-small cell lung cancer.\n* Presence of symptomatic brain metastases at the start of treatment.\n* Concurrent participation in another interventional clinical trial for cancer treatment.\n* History of tracheoesophageal fistula, gastrointestinal perforation, gastrointestinal fistula, or intra-abdominal abscess within 6 months prior to treatment initiation.\n* Presence of severe cardiovascular or cerebrovascular disease, including but not limited to:\n\nCerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction, or significant vascular disease (including but not limited to aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to randomization; Unstable angina; Heart failure classified as New York Heart Association (NYHA) class ≥ II; Mean resting corrected QT interval (QTc) \\>470 ms; Any clinically significant resting electrocardiogram (ECG) rhythm, conduction, or morphological abnormalities, such as complete left bundle branch block, third-degree atrioventricular (AV) block, second-degree AV block, or PR interval \\>250 ms; Any factors that increase the risk of QTc prolongation or arrhythmic events, including heart failure, electrolyte abnormalities (serum\u002Fplasma potassium \\\u003C LLN; magnesium \\\u003C LLN; calcium \\\u003C LLN), congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death of a first-degree relative before the age of 40, or concomitant use of medications known to prolong the QT interval and induce torsades de pointes.\n\n* Major surgical procedures performed within 4 weeks prior to enrollment or planned during the study period.\n* Bleeding tendency, high risk of bleeding, or coagulation disorders, including thrombotic events within 6 months prior to randomization and\u002For history of hemoptysis within 3 months prior to randomization (defined as ≥2.5 mL per episode).\n* Presence of unhealed wounds, active gastrointestinal ulcers, or fractures (excluding healed historical fractures).\n* Known or suspected hypersensitivity to tislelizumab and\u002For any of its excipients.\n* Pregnant or breastfeeding women.\n* Women of childbearing potential or male participants who are unwilling to use effective contraception during the study and for 6 months after the last dose of study treatment.\n* Any other condition that, in the opinion of the investigator, would render the participant unsuitable for enrollment in this study.",{"count":627,"type":21},[58],"The purpose of this clinical trial is to evaluate progression-free survival (PFS) of microwave ablation in combination with tislelizumab and docetaxel in patients with advanced non-small cell lung cancer (NSCLC) who have progressed following first-line immunotherapy combined with chemotherapy.\n\nParticipants with advanced NSCLC who experienced disease progression after first-line immunotherapy plus chemotherapy will receive the following treatments:\n\n1. Tislelizumab: 200 mg administered intravenously every 3 weeks (Q3W)\n2. Docetaxel: 75 mg\u002Fm² administered intravenously every 3 weeks (Q3W) for 4-6 cycles\n3. Microwave ablation, administered per protocol",[33,354],"2026-04-07",{"date":788,"type":39},"2026-04-14",{"date":790,"type":21},"2026-05-01",{"date":792,"type":21},"2028-12-31",{"name":794,"class":312},"Tianjin Medical University Cancer Institute and Hospital",{"id":796,"slug":797,"hasResults":12,"nctId":798,"briefTitle":799,"officialTitle":800,"acronym":801,"eligibilityCriteria":802,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":529,"enrollmentInfo":803,"targetDuration":4,"studyType":22,"phases":804,"briefSummary":805,"conditions":806,"keywords":807,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":812,"startDateStruct":814,"completionDateStruct":816,"leadSponsor":818,"locationsCount":339},"100620164","phase-1-neoadjuvant-therapy-with-ensartinib-combined-with-chemotherapy-for-alk-positive-non---small-cell-lung-cancer-nsclc-100620164","NCT07354061","Neoadjuvant Therapy With Ensartinib Combined With Chemotherapy for ALK-positive Non - Small Cell Lung Cancer (NSCLC)","A Single-arm, Multicenter Clinical Study of Ensartinib Combined With Chemotherapy as Neoadjuvant Therapy for ALK-positive Non-small Cell Lung Cancer (NSCLC) (TD-ENSEMBLE Study)","TD-ENSEMBLE","Inclusion Criteria:\n\n1. Provide informed consent prior to any study-specific procedures.\n2. Aged between 18 and 75 years old (inclusive).\n3. Histologically or cytologically confirmed lung adenocarcinoma via biopsy performed within 60 days prior to study enrollment.\n4. Surgically resectable Stage II-IIIB (N2) lung adenocarcinoma (AJCC 8th Edition TNM Staging).\n5. Confirmed ALK fusion mutation by detection methods recommended by NCCN guidelines.\n6. Presence of at least one accurately measurable lesion, with the longest diameter ≥10 mm on baseline computed tomography (CT) scan (or lymph nodes with a short axis ≥15 mm) and suitable for accurate repeated measurements.\n7. ECOG performance status of 0-1.\n8. Adequate hematological, biochemical, and organ function:\n\n   1. Hemoglobin ≥90 g\u002FL (can be maintained or exceeded via transfusion);\n   2. Absolute neutrophil count ≥1.5×10⁹\u002FL;\n   3. Platelet count ≥90×10⁹\u002FL;\n   4. Total bilirubin ≤2× upper limit of normal (ULN);\n   5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× ULN;\n   6. Creatinine ≤1.5× ULN; and creatinine clearance ≥60 mL\u002Fmin.\n9. Adequate cardiopulmonary function suitable for surgical treatment (assessed by ECG, echocardiography, pulmonary function tests, or blood gas analysis).\n10. For female subjects of childbearing potential: Must use highly effective contraception for at least 2 weeks prior to initiation of study drug, have a negative pregnancy test, and not be breastfeeding at the start of dosing. Alternatively, must meet one of the following criteria at screening to demonstrate non-childbearing potential:\n\n    1. Postmenopausal, defined as over 50 years old with amenorrhea for at least 12 months following cessation of all exogenous hormonal therapy.\n    2. Women under 50 years old may be considered postmenopausal if they have amenorrhea for 12 months or more following cessation of exogenous hormone therapy and have luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels within the postmenopausal range.\n    3. Documented irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not including tubal ligation.\n11. For male subjects with partners of childbearing potential: Must agree to use effective contraceptive methods during the study period and for 3 months after the last dose of study drug\n\nExclusion Criteria:\n\n1. Presence of squamous cell carcinoma, large cell neuroendocrine carcinoma, or small cell carcinoma components.\n2. Prior exposure to other anti-tumor therapies before enrollment.\n3. Patient is pregnant or breastfeeding.\n4. Current use of (or inability to discontinue use at least 3 weeks prior to receiving the first dose of study treatment) drugs or herbal supplements known to be strong inducers of CYP3A4. All patients must try to avoid concomitant use or ingestion of any drugs, herbal supplements, and\u002For foods known to have CYP3A4 induction effects.\n5. Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension and active bleeding, which in the investigator's opinion would compromise the patient's participation in the study or protocol compliance, or active infections including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.\n6. Prior history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any current evidence of active ILD.\n7. History of hypersensitivity to active or inactive excipients of Ensartinib or drugs with similar chemical structures or classes to Ensartinib, as well as uncontrollable nausea and vomiting, chronic gastrointestinal diseases, inability to swallow formulated medication, or prior extensive bowel resection that would preclude adequate absorption of Ensartinib.\n8. Intolerance to chemotherapy or refusal of chemotherapy.\n9. Any of the following cardiac criteria:\n\n   1. Mean resting corrected QT interval (QTc) \\> 470 msec obtained from three ECGs using the screening ECG machine's QTc value.\n   2. Any clinically significant abnormalities in rhythm, conduction, or morphology of resting ECG, such as left bundle branch block, third-degree heart block, or second-degree heart block.\n   3. Any factors that increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death under 40 years of age in first-degree relatives, or any concomitant medication known to prolong the QT interval.\n10. History of definite neurological or psychiatric disorders, including epilepsy or dementia.\n11. Any other conditions deemed by the investigator as unsuitable for enrollment.",{"count":627,"type":21},[24,58],"The goal of this clinical trial is to learn if Ensartinib combined with chemotherapy works as a neoadjuvant treatment for patients with stage II-IIIB (N2) ALK-positive non-small cell lung cancer (NSCLC). It will also learn about the safety of this combination therapy. The main questions it aims to answer are:\n\n* Does Ensartinib combined with chemotherapy lead to a pathological complete response (pCR) in surgically removed tumor tissue after neoadjuvant treatment?\n* What medical problems do participants have when taking Ensartinib combined with chemotherapy? This is a single-arm study, meaning all participants will receive the investigational treatment. There is no placebo or active comparator group. The study will be conducted in two stages; the second stage will proceed only if no special, unexpected, or serious adverse events related to Ensartinib occur during the first stage involving 5 participants.\n\nParticipants will:\n\n* Receive neoadjuvant treatment with Ensartinib (taken orally once daily) plus Pemetrexed and Carboplatin (administered intravenously every 3 weeks) for 9 weeks (3 cycles).\n* Undergo surgical resection within 4 weeks after completing neoadjuvant therapy.\n* Attend regular clinic visits for check-ups, blood tests, and imaging scans (CT, MRI) according to a detailed schedule during the neoadjuvant, surgical, and long-term follow-up periods (up to 10 years).\n* Be monitored for adverse events and survival outcomes.",[33],[808,809,810,811],"Ensartinib","neoadjuvant","ALK - positive","Resectable",{"date":813,"type":39},"2026-04-01",{"date":815,"type":39},"2026-03-25",{"date":817,"type":21},"2030-12-30",{"name":774,"class":312},{"id":820,"slug":821,"hasResults":12,"nctId":822,"briefTitle":823,"officialTitle":824,"acronym":825,"eligibilityCriteria":826,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":827,"targetDuration":4,"studyType":22,"phases":829,"briefSummary":830,"conditions":831,"keywords":836,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":854,"lastUpdatePostDateStruct":855,"startDateStruct":857,"completionDateStruct":859,"leadSponsor":860,"locationsCount":862},"100607539","phase-1-177lu-betabart-in-patients-with-relapsedrefractory-locally-advanced-inoperable-or-metastatic-solid-tumors-100607539","NCT07189871","177Lu-BetaBart in Patients With Relapsed\u002FRefractory, Locally Advanced Inoperable, or Metastatic Solid Tumors","A Phase 1\u002F2a Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients With Relapsed\u002FRefractory, Locally Advanced Inoperable, or Metastatic Solid Tumors","BetaBart","Inclusion Criteria:\n\n1. Willing and able to provide informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.\n2. Participants ≥ 18 years of age.\n3. Participants with a documented history of histopathologically confirmed CRPC\\*, CRC, NSCLC, SCLC, HNSCC, ovarian cancer, cervical cancer, endometrial cancer, TNBC, or ESCC. (Note: inclusion or exclusion criteria below marked with \\* refer to CRPC only, criteria without \\* refer to all tumor indications including CRPC)\n\n   a. \\*Progressive CRPC defined as castrate levels of testosterone and progressing by at least one of the following criteria: i. Serum PSA progression consisting of two consecutive increases in PSA measured at least 1 week apart. The minimal baseline value is 2.0 ng\u002FmL.\n\n   ii. Soft tissue progression defined as a ≥20% increase in the sum of the diameter (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest sum of the diameter since the previous treatment was started or the appearance of one or more new lesions by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI).\n\n   iii. Progression of bone disease defined by Prostate Cancer Working Group 3 (PCWG3) as evaluable disease or new bone lesions by bone scan.\n\n   iv. Identification of new soft tissue or bone lesions on prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging.\n\n   b. \\*Metastatic disease defined as either or both of the following: i. Documented M1 disease on conventional imaging (CT\u002FMRI of the chest\u002Fabdomen\u002Fpelvis and\u002For Technetium 99m \\[99mTc\\] whole-body bone scan) ii. Identification of bone lesion(s), extra-pelvic soft tissue lesion(s), or visceral metastases on PSMA PET imaging with an FDA-approved imaging agent (e.g., 68Ga-PSMA-11, 18F-DCFPyL, or 18F-rhPSMA-7.3) c. \\*Progression following treatment with ADT and at least one ARSI (e.g., enzalutamide, apalutamide, darolutamide, and\u002For abiraterone acetate). If a participant is currently on ADT, they should continue ADT for the duration of their participation in the study but will not be permitted to start a new therapy or ADT regimen. If a participant has progressed on an ARSI, they will have the option to remain on the same ARSI or discontinue therapy. If they discontinue the ARSI, a 28-day washout period will be required prior to initiating study intervention.\n\n   d. Prior definitive and palliative external beam radiation therapy and stereotactic body radiation therapy is allowed.\n\n   Note: Participants with extended external beam radiation therapy to the axial skeleton, which in the opinion of the Investigator may pose a risk for increased myelotoxicity, will be discussed with the Sponsor to determine eligibility.\n\n   e. Participants with liver metastases are eligible if they meet the following criteria: i. ≤3 lesions i. All lesions must be ≤2 cm in the short axis ii. SUVmean ≥2 x that of liver parenchyma f. \\*Prior treatment with one taxane-based chemotherapy is allowed but not required. A taxane-based chemotherapy is defined as a minimum exposure of two cycles of a taxane chemotherapy.\n4. Participants must have documented disease progression during or after their most recent line of anticancer therapy. Participants must be refractory to or intolerant of standard of care therapy or have no standard of care therapy available that is likely to provide clinical benefit. Any number of prior treatment lines are allowed.\n5. Must have at least 1 measurable target lesion according to RECIST v1.1. (Note: this does not apply for CRPC)\n6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n7. Participants must have a life expectancy of ≥ 4 months in the opinion of the Investigator.\n8. Participants of child-bearing potential (CBP) must have a negative β-hCG test and must not be breastfeeding. Participants of CBP are defined as those who are not surgically sterile or post-menopausal. Participants will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. Participants \\\u003C 50 years of age who meet the criteria for post-menopausal status without previous surgical sterilization should be considered for further investigation with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels to confirm serological post-menopausal status.\n9. Participants of CBP must agree to use a highly effective method of contraception during the study and for 6 months after the last dose of 177Lu-BetaBart, as described in Appendix 4.\n10. Male participants who are able to father a child must agree to avoid impregnating a partner and to adhere to a highly effective method of contraception during the study and for 6 months after the last dose of 177Lu-BetaBart, as described in Appendix 4. All male participants must agree to not donate sperm during the study and for 6 months after the last dose of 177Lu-BetaBart.\n11. Participants who have received prior radiation therapy \\>28 days before the first dose of 177Lu-BetaBart are permitted. Documentation of the dates the radiotherapy was received, the cumulative dose, and the absorbed dose to critical organs, if available, should be provided.\n12. Participants with previously treated brain metastases are eligible to participate if:\n\n    * they are neurologically and radiologically stable (no evidence of progression by imaging; same imaging modality \\[MRI or CT scan\\] must be used for each assessment) for at least 28 days prior to the first dose of 177Lu-BetaBart; and\n    * do not require corticosteroids to treat associated neurological symptoms or if required, are on a stable dose of corticosteroids not exceeding 10 mg\u002Fday of prednisone (or equivalent), and\n    * have no history of leptomeningeal disease or spinal cord compression.\n\nExclusion Criteria:\n\n1. History of prior organ transplant.\n2. Any other known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer. Participants with a history of malignancies of low recurrence potential who have received curative-intent therapy may be approved on a case-by-case basis in discussion with the Sponsor, if it is determined not to put the participant at an increased risk of adverse drug effects and\u002For interfere with the integrity of the study outcome.\n3. Have any medical condition that would, in the Investigator's judgment, prevent the participant's full participation in the clinical study due to safety concerns or compliance with clinical study procedures such as participants with severe claustrophobia who are unresponsive to oral anxiolytics, participants with low back pain who cannot lie comfortably on an imaging table, participants who are hyperactive or hyperkinetic such that they cannot tolerate lying still for multiple time point imaging procedures, etc.\n4. Residual toxicity ≥ Grade 2 from prior anti-cancer therapy (except alopecia and peripheral sensory neuropathy).\n5. History of uncontrolled allergic reactions and\u002For known or expected hypersensitivity to protein therapeutics, 177Lu-BetaBart, or any of its excipients.\n6. Inadequate organ functions as reflected in laboratory parameters:\n\n   * Estimated glomerular filtration rate (eGFR) \\\u003C 50 mL\u002Fmin adjusted for participant's body surface area using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI 2021) formula\n   * Platelet count of \\\u003C 100 x 109\u002FL\n   * Absolute neutrophil count (ANC) \\\u003C 1.5 x 109\u002FL\n   * Hemoglobin \\\u003C 9 g\u002FdL\n   * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 x upper limit of normal (ULN), or \\> 5 x ULN for participants with known liver metastases\n   * Total bilirubin \\> 1.5 x ULN, except for participants with documented Gilbert's syndrome who are eligible if total bilirubin ≤ 3 x ULN\n   * For participants not taking warfarin or other anticoagulants: INR ≤1.5 or PT ≤1.5 x ULN; and either PTT or aPTT ≤1.5 x ULN. Participants taking warfarin must be on a stable dose that results in a stable INR \\\u003C3.5. Among participants receiving other anticoagulant therapy, PT or aPTT must be within the intended therapeutic range of the anticoagulant.\n7. Participants requiring blood product transfusion within 2 weeks of first dose of 177Lu-BetaBart are not eligible to participate.\n8. \\*Participants with CRPC who have received prior Lu-177-PSMA radioligand therapy.\n9. Clinically significant cardiovascular disease including but not limited to:\n\n   * Unstable angina\n   * Acute myocardial infarction within 6 months prior to screening\n   * New York Heart Association (NYHA) Class II or greater congestive heart failure\n   * Clinically significant abnormalities in rhythm, conduction or morphology on resting ECG (e.g., complete left bundle branch block, third degree heart block)\n   * Known left ventricular ejection fraction \\\u003C 50%\n   * QTcF \\> 480 msec on screening electrocardiogram (ECG), or congenital long QT syndrome.\n10. Participation in any other interventional investigational trial for treatment of underlying malignancy at the time of informed consent signature.\n11. Participants who are pregnant or breastfeeding.\n12. Major surgery within 4 weeks prior to first dose of 177Lu-BetaBart.\n13. Received anti-cancer therapy, including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy or investigational device, ≤ 28 days (or 5 half-lives for biologic\u002Fnon-cytotoxic agents, whichever is shorter), prior to the first dose of 177Lu-BetaBart.\n14. Known active hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or known active hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection.\n\n    * Active viral (any etiology) hepatitis participants are excluded.\n    * Participants with serologic evidence of chronic hepatitis B virus (HBV) infection (defined by a positive hepatitis B surface antigen test and a positive anti hepatitis core antigen antibody test) who have a viral load below the limit quantification (HBV DNA titer \\\u003C 1000 cps\u002FmL or 200 IU\u002FmL) and are not currently on viral suppressive therapy may be eligible and should be discussed with the Sponsor's Medical Monitor (or designee).\n    * Note, participants with a history of HCV infection should have completed curative antiviral treatment and have a viral load below the limit of quantification to be eligible to enroll into the study.\n    * No testing for HBV or HCV is required unless mandated by local health authority.\n15. Any uncontrolled intercurrent illness or clinically significant uncontrolled condition(s), including but not limited to active bacterial, fungal, or viral infections requiring systemic therapy.\n16. Untreated moderate to severe hydronephrosis. If hydronephrosis is corrected via stent or nephrostomy, hydronephrosis will be considered resolved.\n17. \\*Prescence of a superscan by nuclear medicine\u002F99mTc bone scan.\n18. Active autoimmune disease that has required systemic treatment within 90 days (i.e., with the use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid \\[stable \u002F low doses of ≤10 mg\u002Fday prednisone or equivalent dose\\]) for adrenal or pituitary insufficiency is allowed.\n19. Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, or any other condition, which in the judgment of the investigator could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the subject to safety risks.",{"count":828,"type":21},61,[24,58],"A Phase 1\u002F2a Dose Escalation and Expansion Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients with Relapsed\u002FRefractory, Locally Advanced Inoperable, or Metastatic Solid Tumors",[832,167,33,164,268,165,556,833,834,835],"Castration-Resistant Prostate Cancer (CRPC)","Small Cell Lung Cancer (SCLC )","Head &Amp; Neck Squamous Cell Carcinoma (HNSCC)","Esophageal Squamous Cell Carcinoma (ESCC)",[837,838,839,840,841,842,843,844,845,846,847,848,849,850,851,852,853],"Castration-resistant prostate cancer (CRPC)","colorectal cancer (CRC)","non-small-cell lung cancer (NSCLC)","small-cell lung cancer (SCLC)","head and neck squamous cell carcinoma (HNSCC)","ovarian cancer","cervical cancer","endometrial cancer","triple negative breast cancer (TNBC)","esophageal squamous cell carcinoma (ESCC)","B7-H3","177Lu","radiotheranostics","radioligand therapy","radioimmunotherapy","monoclonal antibody","metastatic solid tumors","2026-03-24",{"date":856,"type":39},"2026-03-27",{"date":858,"type":39},"2026-02-23",{"date":599,"type":21},{"name":861,"class":46},"Radiopharm Theranostics, Ltd",4,{"id":864,"slug":865,"hasResults":12,"nctId":866,"briefTitle":867,"officialTitle":868,"acronym":869,"eligibilityCriteria":870,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":529,"enrollmentInfo":871,"targetDuration":4,"studyType":22,"phases":873,"briefSummary":874,"conditions":875,"keywords":876,"overallStatus":412,"whyStopped":4,"lastUpdateSubmitDate":877,"lastUpdatePostDateStruct":878,"startDateStruct":879,"completionDateStruct":881,"leadSponsor":883,"locationsCount":4},"100626666","phase-2-study-of-sacituzumab-tirumotecan-combined-with-toripalimab-for-resectable-stage-ii-iiib-nsclc-100626666","NCT07438600","Study of Sacituzumab Tirumotecan Combined With Toripalimab for Resectable Stage II-IIIB NSCLC","A Single-center, Phase II Clinical Study of Sacituzumab Tirumotecan Combined With Toripalimab as Neoadjuvant Therapy for Resectable Stage II-IIIB NSCLC","TianjinCIH","Inclusion Criteria:\n\n1. Age ≥18 years at the time of informed consent signing, either sex;\n2. ECOG performance status score of 0-1 within 7 days prior to dosing;\n3. Histologically or cytologically confirmed NSCLC;\n4. Negative for EGFR sensitive mutations (no exon 19 deletion or exon 21 L858R substitution mutation) and negative for ALK fusion gene;\n5. No prior local treatment (surgery or radiotherapy) for NSCLC and no prior systemic antineoplastic therapy, including cytotoxic therapy, targeted therapy (including tyrosine kinase inhibitors or monoclonal antibodies), cellular therapy, immunotherapy, traditional Chinese medicine therapy, and any other investigational drug therapy;\n6. Patients with resectable stage II-IIIB NSCLC as assessed by MDT (according to UICC\u002FAJCC 8th edition TNM staging);\n7. At least one measurable lesion (according to RECIST 1.1 criteria);\n8. Patients who agree to undergo radical surgical treatment;\n9. Surgical evaluation confirms operability with no contraindications to surgery;\n10. Adequate organ and bone marrow function (no transfusion, recombinant human thrombopoietin, or colony-stimulating factor treatment within 2 weeks prior to first dosing), defined as follows:\n\n    1. Hematology: Absolute neutrophil count (NEUT#) ≥ 1.5×10⁹\u002FL; Platelets (PLT) ≥ 100×10⁹\u002FL; Hemoglobin ≥ 90 g\u002FdL;\n    2. Hepatic function: Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP) ≤ 2.5×upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5×ULN;\n    3. Renal function: Creatinine clearance (Ccr) ≥ 60 ml\u002Fmin (Cockcroft-Gault formula, see Appendix);\n    4. Coagulation function: International normalized ratio (INR), Activated partial thromboplastin time (APTT), and Prothrombin time (PT) ≤ 1.5×ULN;\n    5. Cardiac function: Echocardiography (ECHO) or Multiple gated acquisition (MUGA) scan showing left ventricular ejection fraction (LVEF) ≥ 50%;\n11. For female subjects of childbearing potential and male subjects with partners of childbearing potential, must agree to use effective medical contraception from the time of informed consent signing until 6 months after the last dose (see Appendix 2 for details);\n12. Subjects voluntarily participate in this study, sign informed consent, and are able to comply with protocol-specified visits and related procedures.\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed combined small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components;\n2. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or any other antibodies or drugs specifically targeting T-cell co-stimulation or checkpoint pathways;\n3. Prior treatment with TROP2-targeted therapy and\u002For topoisomerase I inhibitors;\n4. Requirement for strong inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4) within 2 weeks prior to first dosing and during the study (strong CYP3A4 inhibitors or inducers are not permitted in this study; Appendix 6 lists representative drugs of strong CYP3A4 inhibitors or inducers); all subjects must avoid concomitant use of any drugs, herbal supplements, and\u002For foods known to induce CYP3A4.\n5. Other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma, or cutaneous squamous cell carcinoma;\n6. Known history of hypersensitivity to study drugs and their components, history of immunodeficiency, or history of organ transplantation;\n7. History of interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment (non-infectious), current ILD or non-infectious pneumonitis, or suspected ILD or non-infectious pneumonitis that cannot be excluded by imaging at screening; clinically significant pulmonary impairment due to pulmonary comorbidities, including but not limited to any underlying pulmonary disease (such as pulmonary embolism within 3 months prior to dosing, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory disease that may involve the lungs (i.e., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or prior pneumonectomy;\n8. Active autoimmune disease requiring systemic treatment within the past 2 years (hormone replacement therapy is not considered systemic treatment, such as type 1 diabetes, hypothyroidism requiring only thyroid hormone replacement therapy, adrenal or pituitary insufficiency requiring only physiologic doses of glucocorticoid replacement therapy);\n9. Active infection requiring systemic treatment within 2 weeks prior to first dosing;\n10. Active hepatitis B \\[hepatitis B surface antigen (HBsAg) positive, HBV-DNA testing required; HBV-DNA ≥ 500 IU\u002FmL or above the lower limit of detection, whichever is higher\\] or hepatitis C (hepatitis C antibody positive, and HCV-RNA above the lower limit of detection). Note: For HBsAg-positive subjects, anti-hepatitis B virus treatment is required during study treatment;\n11. Positive human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection;\n12. Severe concomitant diseases that endanger patient safety or affect study completion, as judged by the investigator, including but not limited to uncontrolled hypertension with medication, severe diabetes, active infection, etc.;\n13. Documented severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or history of corneal disease that prevents delayed corneal healing;\n14. Pregnant or lactating women;\n15. Any condition that interferes with the evaluation of study drugs, subject safety, or interpretation of study results, or any other condition deemed by the investigator as unsuitable for participation in this study.",{"count":872,"type":21},38,[58],"This is a prospective, open, single-center, single-arm phase II clinical study in non-small cell lung cancer (NSCLC) without common EGFR-sensitive mutations (Ex19del and L858R) or ALK fusion variants identified in the central laboratory. To evaluate the efficacy and safety of neoadjuvant therapy of sacituzumab tirumotecan combined with toripalimab.",[33],[176],"2026-03-23",{"date":856,"type":39},{"date":880,"type":21},"2026-02-24",{"date":882,"type":21},"2028-02-28",{"name":794,"class":312}]