[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,78,106,137,161],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100633195","phase-1-biomarker-guided-dual-target-car-t-cells-for-advanced-solid-tumors-100633195",false,"NCT07523529","Biomarker-Guided Dual-Target CAR-T Cells for Advanced Solid Tumors","A Phase 1\u002F2, Open-Label, Biomarker-Guided Master Protocol Evaluating Autologous Dual-Target CAR-T Cells Selected From a Predefined Target Library in Adults With Advanced Solid Tumors","SELECT-2CAR","Inclusion Criteria:\n\n* Age 18-75 years at consent\n* Histologically or cytologically confirmed advanced unresectable, metastatic, or recurrent solid malignancy (including recurrent high-grade glioma for CNSspecific pairs) for which standard curative therapy does not exist, is not tolerated, or has failed.\n* At least one predefined dual-target pair qualifies on central biomarker review. Recommended working thresholds: primary antigen \\>= 2+ intensity in \\>= 50% of viable tumor cells (or pair-specific equivalent) AND secondary antigen detectable in \\>= 25% of viable tumor cells, with acceptable normal-tissue risk after pathology review\n* At least 1 measurable lesion by RECIST 1.1, or measurable \u002F evaluable disease by RANO for CNS cohorts.\n* ECOG performance status 0-1 (CNS cohort may allow Karnofsky \\>= 70 or ECOG 0-2 if justified).\n* Adequate organ function: ANC \\>= 1.0 x 10\\^9\u002FL, platelets \\>= 75 x 10\\^9\u002FL, hemoglobin \\>= 8 g\u002FdL, creatinine clearance \\>= 50 mL\u002Fmin, AST \u002F ALT \\\u003C= 3 x ULN (\\\u003C= 5 x ULN if liver involvement), total bilirubin \\\u003C= 1.5 x ULN unless Gilbert syndrome, LVEF \\>= 45%, oxygen saturation \\>= 92% on room air.\n* Recovered to Grade \\\u003C= 1 from acute toxicities of prior anticancer therapy (except alopecia, stable endocrinopathies, or other protocol-allowed residual toxicities).\n* Adequate venous access and ability to undergo leukapheresis; successful manufacture of a release-qualified autologous dual-target CAR-T product.\n* Life expectancy \\>= 12 weeks.\n* Negative pregnancy test for persons of childbearing potential and agreement to use highly effective contraception per protocol.\n* Ability to understand and sign informed consent and comply with study follow-up, including long-term gene-modified cell monitoring.\n\nExclusion Criteria:\n\n* No qualifying target pair after central review, or target pair considered unsafe because of unacceptable predicted ontarget \u002F off-tumor risk.\n* Prior gene-modified cellular therapy directed against the same target pair within 6 months, or persistent clinically significant toxicity from prior cell \u002F gene therapy.\n* Active uncontrolled infection, including uncontrolled bacterial, fungal, or viral infection; active tuberculosis; uncontrolled HIV; active hepatitis B or C with detectable \u002F unsafe viral burden.\n* Need for systemic corticosteroids \\> 10 mg prednisone equivalent daily or other systemic immunosuppressive therapy within 7 days before lymphodepletion, unless specifically allowed for physiologic replacement or CNS edema management per cohort rules.\n* Active autoimmune disease requiring systemic immunosuppression within the past 2 years, except protocol-allowed stable conditions.\n* Clinically significant cardiovascular disease (for example uncontrolled arrhythmia, recent myocardial infarction, unstable angina, decompensated heart failure), severe pulmonary compromise, or other major comorbidity making cell therapy unsafe.\n* Active symptomatic CNS hemorrhage, uncontrolled seizures, or uncontrolled intracranial hypertension; leptomeningeal disease requiring urgent intervention unless explicitly allowed in a CNS-specific cohort.\n* Pregnancy or breastfeeding.\n* Concurrent second malignancy requiring active systemic treatment, except certain low-risk or definitively treated cancers allowed by protocol.\n* Any condition that, in the investigator's judgment, would interfere with safe participation, product manufacture, infusion, or interpretation of results.","ALL","18 Years","75 Years",{"count":21,"type":22},72,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This is a multicenter, open-label, Phase 1\u002F2 master protocol evaluating autologous dual-target CAR-T cell therapy in adults with advanced solid cancers. After central biomarker screening, each participant is assigned the best-matched dual-target construct from a predefined target-pair library. The trial is designed to test whether biomarkerguided dual targeting can improve tumor control, reduce antigenescape risk, and preserve safety in solid tumors.",[29,30],"Advanced Unresectable","Metastatic",[32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64],"antigen co-expression","B7-H3","bi-specific CAR-T","biomarkerguided","CD133","CD44","CD56","CD70","CLDN18.2","dual-target CAR-T","EGFR","EGFRvIII","GD2","gastric cancer","glioblastoma","GPC3","HER2","hepatocellular carcinoma","IL13Ralpha2","Mesothelin","MUC1","NKG2D","NSCLC","ovarian cancer","pancreatic cancer","PD-L1","prostate cancer","PSMA","solid tumors","tandem CAR-T","TRAIL-R2","triple-negative breast cancer","VEGFR1","RECRUITING","2026-04-05",{"date":68,"type":69},"2026-04-13","ACTUAL",{"date":71,"type":69},"2026-03-02",{"date":73,"type":22},"2028-03-17",{"name":75,"class":76},"Beijing Biotech","INDUSTRY",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":105},"100388125","phase-1-a-dose-finding-phase-1-of-sarilumab-plus-capecitabine-in-her2neu-negative-metastatic-breast-cancer-and-a-single-arm-historically-controlled-phase-2-study-of-sarilumab-plus-capecitabine-in-stage-i-iii-triple-negative-breast-cancer-with-high-risk-residual-disease-empower-100388125","NCT04333706","A Dose Finding Phase 1 of Sarilumab Plus Capecitabine in HER2\u002FNeu-Negative Metastatic Breast Cancer and a Single-arm, Historically-controlled Phase 2 Study of Sarilumab Plus Capecitabine in Stage I-III Triple Negative Breast Cancer With High-Risk Residual Disease (EMPOWER)","EMPOWER","Inclusion Criteria:\n\n* A. Written informed consent obtained from the subject and the ability for the subject to comply with all the study-related procedures.\n* B. Both males and females ≥ eighteen years of age\n* C. A clinical diagnosis of metastatic triple negative or hormone resistant, Her2\u002Fneu-negative breast cancer that has been confirmed histologically at one point during the course of the disease. TNBC is defined as ER\u002FPR IHC positivity rate of \\\u003C10% and Her2Neu-negative (Phase I only)\n* D. A life expectancy of at least 6 months. (Phase I only)\n* E. Any previous cytotoxic chemotherapy must have been a minimum of 3 weeks prior to study drug administration. There is no limit on the number of prior therapies. For ER\u002FPR-positive tumors, endocrine therapy must have been included in at least one of those prior regimens. Prior capecitabine is allowed only if not given in the treatment regimen immediately prior to the enrollment in this study. (Phase I only)\n* F. A diagnosis of TNBC confirmed histologically and defined as ER\u002FPR IHC positivity rate of \\\u003C10% and Her2\u002Fneu-negative. (Phase II and Parallel Baseline Arm only)\n* G. A pathologic confirmation of stage I, or II, or III breast cancer with less than a complete pCR, defined as the absence of residual invasive cancer in resected breast specimen and sampled lymph nodes with residual noninvasive cancer or in situ disease allowed. (Phase II and Parallel Baseline Arm only)\n* H. Must not have received prior systemic treatment for breast cancer except for those included in the neoadjuvant regimen and the neoadjuvant regimen must not have included capecitabine nor sarilumab. (Phase II and Parallel Baseline Arm only)\n* I. An ECOG Performance Status ≤2.\n* J. Adequate organ function defined as:\n\n  1. Absolute neutrophil count (ANC) \\> 1500\u002Fmcl (use of G-CSF is allowed)\n  2. Platelets ≥ 100,000\u002Fmcl\n  3. Hemoglobin ≥ 9 (pRBC +\u002F- ESA are allowed)\n  4. ALT ≤ 5 x ULN\n  5. AST ≤ 5 x ULN\n  6. Bilirubin ≤ 3 x ULN\n  7. GFR ≥ 30 ml\u002Fmin\n* K. Women of childbearing potential (WOCBP) must be using a highly effective method of contraception to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug to minimize the risk of pregnancy. Prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.\n* L. Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 24 weeks following the last dose of study drug.\n\nExclusion Criteria:\n\n* A. Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 24 weeks after the last dose of study drug.\n* B. Females who are pregnant or breastfeeding.\n* C. History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.\n* D. Hepatitis B infection except for prior vaccination. (Phase I and Phase II only).\n* E. Known history of tuberculosis injection. (Phase I and Phase II only).\n* F. A history of diverticulitis. (Phase I and Phase II only).\n* G. Use of live vaccines within 30 days prior to study treatment due to the risk of infection. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella (MMR), varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated vaccines and are not allowed. (Phase I and Phase II only)\n* H. History of other malignancy that in the primary oncologist's estimation has at the time of study participation a higher risk of recurrence or death than the study-related cancer.\n* I. Prisoners or subjects who are involuntarily incarcerated.\n* J. Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.\n* K. Subjects demonstrating an inability to comply with the study and\u002For follow-up procedures.","99 Years",{"count":87,"type":22},65,[25,26],"This study looks to advance a novel and potent strategy to eliminate minimal residual disease (MRD) in triple negative breast cancer (TNBC) present even after multimodal treatment, thereby improving survival and increasing cure rate in this aggressive cancer. Patients with locally advanced TNBC are at high risk of developing lethal metastatic disease within 2 years of diagnosis, especially for those without a pathologic complete response (pCR) after neoadjuvant chemotherapy. The high risk occurs despite surgical excision of the primary tumor and axillary lymph nodes to eliminate residual disease.",[91,30,92,93,94],"Breast","Triple Negative","Cancer","Disseminated Tumor Cell","2026-03-06",{"date":97,"type":69},"2026-03-10",{"date":99,"type":69},"2020-09-26",{"date":101,"type":22},"2027-05-03",{"name":103,"class":104},"University of Southern California","OTHER",3,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":113,"minAge":18,"maxAge":19,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":77},"100620877","phase-2-a-phase-ii-study-of-utidelone-with-toripalimab-in-advanced-cervical-cancer-100620877","NCT07363330","A Phase II Study of Utidelone With Toripalimab in Advanced Cervical Cancer","Utidelone Combined With Toripalimab in Patients With Pretreated Recurrent or Metastatic Cervical Cancers: a Single-Arm, Phase II Study","Inclusion Criteria:\n\n1. Informed Consent: Patients must voluntarily sign an informed consent form prior to any study-related procedures.\n2. Age: Aged ≥18 years and ≤75 years.\n3. Diagnosis: Histologically or cytologically confirmed recurrent or metastatic cervical carcinoma.\n4. Performance Status: With an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n5. Measurable Disease: With at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n6. Prior Therapy:\n\n   * Patients must have received at least one line of standard systemic chemotherapy for recurrent\u002Fmetastatic disease, OR\n   * Patients with rapid disease progression (occurring within 6 months) during or after prior neoadjuvant or concurrent chemoradiotherapy.\n7. Treatment-Related Toxicity: Recovery from all toxicities related to prior anti-cancer therapies to ≤ Grade 1 (according to CTCAE v5.0). Patients with alopecia of any grade are eligible.\n8. Adequate Hematological Function (within 1 week prior to enrollment, per local laboratory reference ranges):\n\n   * White blood cell count (WBC) ≥ 2.5 × 10⁹\u002FL.\n   * Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL.\n   * Platelet count (PLT) ≥ 100 × 10⁹\u002FL.\n   * Hemoglobin (Hb) ≥ 9.0 g\u002FdL (transfusion or erythropoietin use is permitted to meet this criterion).\n9. Adequate Liver and Kidney Functions (within 1 week prior to enrollment, per local laboratory reference ranges):\n\n   * Total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN).\n   * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases).\n   * Calculated creatinine clearance (Ccr) ≥ 60 mL\u002Fmin.\n10. Contraception: Patients of childbearing potential must agree to use highly effective contraception during the study and for at least 90 days after the last dose of study treatment. A negative serum or urine pregnancy test is required for female patients of childbearing potential within 7 days prior to enrollment.\n11. Life Expectancy: Anticipated life expectancy of at least 12 weeks.\n12. Compliance: Patients must be able and willing to comply with the study protocol for treatment and follow-up.\n\nExclusion Criteria:\n\n1. Concurrent Malignancy: History of other active malignancies within the past 5 years, except for adequately treated basal cell carcinoma of the skin.\n2. Recent Anti-cancer Therapy: Any anti-cancer therapy (including chemotherapy, radical radiotherapy, hormonal therapy, biological therapy, or anti-cancer Chinese herbal medicine) within 4 weeks prior to the initiation of study treatment.\n3. Recent Major Surgery\u002FTrauma: Major surgical procedure (excluding diagnostic biopsy) or significant traumatic injury within 4 weeks prior to the first dose of study drug, or anticipation of the need for major surgery during the study period.\n4. Prior Neurotoxicity: History of ≥ Grade 3 neurological adverse reactions attributed to prior anti-microtubule therapy.\n5. Symptomatic CNS Metastases: Patients with symptomatic central nervous system (CNS) metastases.\n6. Pregnancy\u002FLactation: Women who are pregnant or breastfeeding.\n7. Hypersensitivity: Known or suspected hypersensitivity to any component of the study drugs or their excipients.\n8. Severe Comorbidities: Any uncontrolled or severe concurrent medical condition that, in the investigator's judgment, would preclude participation, including but not limited to:\n\n   * Severe cardiovascular or cerebrovascular disease.\n   * Uncontrolled diabetes mellitus or hypertension.\n   * Active severe infection.\n   * Active peptic ulcer disease.\n   * Uncontrolled psychiatric illness\u002Fdisorder.\n9. General Exclusion: Any other condition or circumstance that, in the opinion of the investigator, would compromise the patient's safety or compliance, or make the patient unsuitable for study participation.\n10. Contraindication to Steroids: Conditions for which corticosteroid use is contraindicated.","FEMALE",{"count":115,"type":22},32,[26],"This is a Phase II clinical trial to evaluate the safety and efficacy of Utidelone, a genetically engineered epothilone derivative, combined with Toripalimab, a PD-1 inhibitor, in patients with recurrent or metastatic cervical cancer who have progressed after standard treatments. The study will also assess the safety profile of this combination therapy. The primary objectives of this study include: (1) to determine the objective response rate (ORR), meaning whether the treatment can reduce the size of tumors or make them disappear, according to the RECIST 1.1 criteria; (2) to evaluate the safety of the treatment and document the side effects experienced by participants. This study is for individuals who: (1) are between 18 and 75 years old; (2) have a confirmed diagnosis of recurrent or metastatic cervical cancer; (3) have previously received at least one standard chemotherapy regimen that is no longer controlling the cancer; (4) are in generally good health, as determined by the study investigators. In this single-arm study, all participants will receive the same treatment: Utidelone will be administered by intravenous (IV) infusion over 1.5 hours, once a day for 5 consecutive days, in each 21-day treatment cycle; Toripalimab will be administered by IV infusion over 1.5 hours, once on Day 6 of each 21-day cycle. Participants may continue receiving the study drugs as long as they are benefiting from the treatment and side effects are manageable. Doctors will assess tumor size using imaging scans (like CT or MRI) every 6 weeks to monitor how the cancer responds to treatment. The study will take place at Zhongnan Hospital of Wuhan University and plans to include approximately 32 participants.",[119,120,30],"Cervical Cancer","Recurrent",[122,123,124,125,126],"cervical cancer","recurrent \u002F metastatic","Utidelone","Toripalimab","phase Ⅱ trial","NOT_YET_RECRUITING","2026-01-22",{"date":130,"type":69},"2026-01-26",{"date":132,"type":22},"2026-02-01",{"date":134,"type":22},"2028-12-31",{"name":136,"class":104},"Zhongnan Hospital",{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":23,"phases":147,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":77},"100475593","phase-2-surufatinib-and-sintilimab-in-combination-with-capecitabine-for-metastatic-adenocarcinoma-of-small-intestine-or-appendix-carcinoma-100475593","NCT05472948","Surufatinib and Sintilimab in Combination With Capecitabine for Metastatic Adenocarcinoma of Small Intestine or Appendix Carcinoma","Surufatinib and Sintilimab in Combination With Capecitabine for Previously Treated Metastatic Small Bowel Adenocarcinoma and Appendiceal Carcinoma: A Single-arm, Multi-center, Phase Ib\u002FII Trial","Inclusion Criteria:\n\n1. Histological or cytological documentation of adenocarcinoma of Small Intestine or Appendix Carcinoma. All other histological types are excluded.\n2. Subjects with metastatic adenocarcinoma of Small Intestine or Appendix Carcinoma.\n3. Subjects must have failed at least one line of prior treatment.\n4. Progression during or within 3 months following the last administration of approved standard therapies . 4.1 Subjects an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy. 4.2 Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease will also be allowed into the study. 4.3 Subjects may have received prior treatment with Avastin (bevacizumab)\n5. Subjects must have measurable or non measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1.\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 1.\n7. Life expectancy of at least 3 months.\n8. Adequate bone marrow, liver and renal function as assessed by the laboratory required by protocol.\n\nExclusion Criteria:\n\n1. Prior treatment with Surufatinib\n2. Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody, anti-cytotoxic T lymphocyte-associated antigen 4 (cytotoxic T- lymphocyte-associated Protein 4, CTLA-4) antibody or other drug\u002Fantibody that acts on T cell costimulation or checkpoint pathways.\n3. Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors \\[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)\\].\n4. Cardiological disease including Congestive heart failure, Unstable angina, Myocardial infarction, Cardiac arrhythmias requiring anti-arrhythmic therapy.\n5. Uncontrolled hypertension. (Systolic blood pressure 150 mmHg or diastolic pressure 90 mmHg despite optimal medical management).\n6. Pleural effusion or ascites that causes respiratory compromise. Arterial or venous thrombotic or embolic events.\n7. Any history of or currently known brain metastases.\n8. Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.\n9. Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 week.","70 Years",{"count":146,"type":22},36,[26],"To explore the safety and efficacy of Surufatinib and Sintilimab in Combination With Capecitabine in Patients With Previously Treated Metastatic Adenocarcinoma of Small Intestine or Appendix Carcinoma : a Single-arm, a Single-center , Phase 2 Trial. Meanwhile, Exploring the maximum tolerant dose or recommended II research dose of Surufatinib combined with a fixed dose of Sintilimab and Capecitabine using 3 + 3 dose climbing experiment.",[150,151,30],"Adenocarcinoma of Small Intestine","Appendix Carcinoma","2025-12-09",{"date":154,"type":69},"2025-12-17",{"date":156,"type":69},"2023-02-01",{"date":158,"type":22},"2027-12-30",{"name":160,"class":104},"Sun Yat-sen University",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":23,"phases":171,"briefSummary":172,"conditions":173,"keywords":194,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":238},"100505964","phase-1-pre-i-spy-phase-iib-oncology-platform-program-100505964","NCT05868226","PRE-I-SPY Phase I\u002FIb Oncology Platform Program","PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I\u002FIb Platform Trial","PRE-I-SPY-PI","General Inclusion Criteria (GIC):\n\n* GIC1: The participant must have ability to understand and willingness to provide signed written informed consent prior to any study related assessments and procedures and for collection of archival FFPE blocks (freshly cut 14 unstained tumor slides would be acceptable).\n* GIC2: Age ≥ 18 years at the time of signing the informed consent\n* GIC3: Gender: Male or female (premenopausal and postmenopausal)\n* GIC4: ECOG performance status Grade 0-2\n* GIC5: Estimated life expectancy \\> 12 weeks at the start of investigational medicinal product (IMP) treatment.\n* GIC6: Adequate organ function, evidenced by the following laboratory results within 30 days of the start of IMP:\n\n  * Absolute neutrophil count ≥ 1,500\u002Fmm3\n  * Platelet count ≥ 100,000\u002Fmm3\n  * Hemoglobin ≥ 9.0 g\u002FdL with no blood transfusion in the past 28 days\n  * Total bilirubin ≤ 1.5 x the upper limit of normal (ULN)\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN\n  * Estimated Creatinine clearance (using Cockcroft-Gault formula) ≥ 60 mL\u002Fmin for small molecules and \\>30 mL\u002Fmin for monoclonal antibodies unless otherwise specified in the Arm Specific Eligibility.\n\nThese cut-off values may be modified with supporting data for specific drug regimens.\n\n* GIC7: Non-Pregnant: Serum or urine pregnancy test must be negative within 14 days of IMP treatment start in women of childbearing potential. Pregnancy testing does not need to be pursued in patients who are judged as postmenopausal before enrollment, or who have undergone bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation. If male, they must agree to refrain from donating sperm during treatment.\n* GIC8: Contraception: Women of childbearing potential and men must be willing to use adequate contraception for the duration of protocol treatment. Additional information regarding contraception for the specific treatment arm will be added to the drug arm description. Adequate contraception is defined as one highly effective form (i.e., abstinence, (fe)male sterilization) OR two effective forms (e.g., non-hormonal IUD and condom \u002F occlusive cap with spermicidal foam \u002F gel \u002F film \u002F cream \u002F suppository).\n* GIC9: Prior therapy effects: Resolution of all acute toxic effects of prior therapy, including radiotherapy, to grade ≤1 and neuropathy to grade ≤2 (except toxicities not considered a safety risk for the patient) and recovery from surgical procedures.\n* GIC10: Participant compliance: Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n* Additional arm specific inclusion criteria as needed by drug arm regimen\n\nGeneral Exclusion Criteria (GEC):\n\n* GEC1: Wash out periods: No other anticancer therapy within the following periods:\n\n  * chemotherapy or investigational agents, 3 weeks\n  * mitomycin C and nitrosoureas, 6 weeks\n  * radiotherapy, 3 weeks\n  * targeted therapy, 2 weeks\n  * MAbs, ADCs, and immunotherapy, 3 weeks\n  * endocrine therapy, no washout needed\n* GEC2: Concurrent therapy with other Investigational Products.\n* GEC3: Prior history of drug\u002Fregimen hypersensitivity: History of infusion-related reactions and\u002For hypersensitivity to IMP or excipients of the study drug\u002Fdrugs which led to permanent discontinuation of the treatment.\n* GEC4: Uncontrolled intercurrent illness including (active infection, diabetes, pulmonary embolism in the past 6 months, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements).\n* GEC5: Cardiovascular disease: History (within 6 months prior to start IMP) of clinically significant cardiovascular disease such as unstable angina, congestive heart failure (CHF), myocardial infarction, uncontrolled hypertension, cardiac arrhythmia requiring medication, or baseline corrected QT by Fridericia's formula (QTcF) length \\> 470 msec for men and women. The QTcF cut-off value may be modified with supporting data for specific drug regimens.\n* GEC6: CNS tumoral spread: Active uncontrolled\u002Fsymptomatic central nervous system cancer\u002Fspinal cord compression. Previously treated and clinically stable lesions, as per Investigator's judgment, are permitted. Newly discovered asymptomatic lesions that are not life threatening and do not require urgent local treatment to ensure patient safety, after consultation with study regimen chaperones, may be permitted.\n* GEC7: Liver disease: Patients with clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, or cirrhosis.\n* GEC8: Recent major surgery within 4 weeks prior to start IMP treatment\n* GEC9: Pregnancy or breastfeeding\n* GEC10: Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.\n* GEC11: Other conditions, which in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to complete the study.\n* GEC12: Concomitant malignancies: A diagnosis of a malignancy in the 2 years prior to starting study treatment other than the disease under study. Exceptions include indolent or definitively treated malignancy not expected to require treatment during the study, affect the safety of subjects, or affect the endpoints of the trial.\n* Additional arm specific exclusion criteria as needed by drug arm regimen",{"count":170,"type":22},124,[25],"I-SPY Phase I\u002FIb (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and\u002For other oncology-based trials in a timely manner.",[174,175,176,30,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193],"HER2-positive Breast Cancer","Metastatic Cancer","Metastatic Breast Cancer","HER2-positive Metastatic Breast Cancer","HER2 Mutation-Related Tumors","HER-2 Protein Overexpression","HER2-negative Breast Cancer","Triple Negative Breast Cancer","HR Positive","Hormone Receptor-positive Breast Cancer","Estrogen Receptor Positive Tumor","Progesterone Receptor-positive Breast Cancer","Hormone Receptor Negative Breast Carcinoma","Solid Tumor","Solid Tumor, Adult","Solid Carcinoma","HER2 Low Breast Cancer","HER2 Low Breast Carcinoma","ER Positive Breast Cancer","PR-positive Breast Cancer",[195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223,224,225,226,227,228],"I-SPY Trials","Quantum Leap Healthcare Collaborative","QLHC","I-SPY","I-SPY2","I-SPY1","PRE-ISPY","PRE-I-SPY","I-SPY Phase 1","I-SPY Phase 1b","I-SPY-P1","ISPY","ISPYP1","I-SPY Phase 1 Platform","ISPY2","ISPY1","Phase 1 Platform","Phase 1 Oncology Platform","T-DXd naive","PRE1","PRE2","PRE3","PRE","PRE-I-SPY Phase 1","PRE-I-SPY Phase 1b","ALX148","T-DXd","Enhertu","Zanidatamab","Tucatinib","Ziihera","Tukysa","Evorpacept","QL","2025-04-01",{"date":231,"type":69},"2025-04-04",{"date":233,"type":69},"2023-02-15",{"date":235,"type":22},"2029-12-30",{"name":237,"class":104},"QuantumLeap Healthcare Collaborative",7]