[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tnbc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tnbc":49},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,99,128,159,185,211,230,257,278,300,350,383,405,433,455],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":57,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":98},"100407463","phase-1-the-evaluation-of-pc14586-in-patients-with-advanced-solid-tumors-harboring-a-tp53-y220c-mutation-pynnacle-100407463",false,"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","ALL","12 Years",{"count":19,"type":20},300,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","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.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56],"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","NSCLC (Non-small Cell Lung Cancer)","SCLC","Non-Small Cell Lung Carcinoma","Triple Negative Breast Cancer","TNBC","HER2+ Breast Cancer","Non-Small Cell Lung Cancer","ER\u002FPR Positive Breast Cancer","HER2- Breast Cancer","HER2-positive Breast Cancer","HER2-negative Breast Cancer","ER\u002FPR(+), Her2(-) Breast Cancer",[58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85],"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","RECRUITING","2026-06-24",{"date":89,"type":90},"2026-06-26","ACTUAL",{"date":92,"type":90},"2020-10-29",{"date":94,"type":20},"2027-12-31",{"name":96,"class":97},"PMV Pharmaceuticals, Inc","INDUSTRY",77,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":21,"phases":108,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":127},"100635399","phase-2-phase-ii-trial-of-pembrolizumabchemotherapy-with-live-biotherapeutic-product-mo-03-in-patients-with-early-stage-triple-negative-breast-cancer-100635399","NCT07552181","Phase II Trial of Pembrolizumab\u002FChemotherapy With Live Biotherapeutic Product MO-03 in Patients With Early Stage Triple Negative Breast Cancer","Inclusion Criteria:\n\n* Female or male age ≥ 18 years of age.\n* Patients with high-risk early stage triple negative breast cancer. Triple negative status will be defined as ER≤10%, PR≤10%, HER2 negative (by FISH) per ASCO-CAP guidelines.\n* Clinically staging T1c any N M0 or any T N1-3 M0.\n* Willing to provide FFPE from baseline standard of care biopsy and post-treatment residual tumor at the time of surgery.\n* ECOG 0-1\n* Patients must have adequate organ function as defined in the following. Specimens must be collected within 28 days prior to the start of study treatment.\n* For patients who will receive regimen 1 only: Participants must have adequate cardiac function. Participants must have left ventricular ejection fraction ≥ 50% as assessed by either ECHO or MUGA within 28 days prior to the start of treatment. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and must be class 2B or better.\n* Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test within 28 days of the start of treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Male participants: A male participant must agree to use a contraception as detailed in Appendix B of this protocol during the treatment period and for at least 120 days after the last dose of MO-03 and refrain from donating sperm during this period.\n* Female participants: A female participant is eligible to participate if she is not pregnant (see Appendix B), not breastfeeding, and at least one of the following conditions applies:\n\n  i. Not a woman of childbearing potential (WOCBP) as defined in Appendix B OR ii. Females of child-bearing potential must be willing to use effective contraception during study and for 120 days after the last dose of MO-03.\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Participants with known human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration.\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated.\n\nNote: No testing for Hepatitis B is required unless mandated by local health authority.\n\n* Participant must not have uncontrolled diabetes or hypertension in the opinion of treating investigator.\n* Participant must not have had a major surgery within 14 days prior to screening.\n* Participant must not have severe infection within 14 days prior to enrollment.\n* Prohibited Treatments and\u002For Therapies:\n\n  * Any prior chemotherapy, biological therapy, immunotherapy for the current breast cancer diagnosis prior to start of study intervention\n  * Prior use of immune checkpoint inhibitor is prohibited\n  * Prior breast surgery or radiation therapy for current invasive breast cancer\n  * Participants must not have a diagnosis of immunodeficiency and be receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to enrollment.\n  * Participants must not have active autoimmune disease that has required systemic treatment in 2 years prior to enrollment (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroidreplacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.\n  * Participants must not have a history of (non-infectious) pneumonitis that required steroids or has current (non-infectious) pneumonitis.\n  * Any live vaccine within 30 days prior to the first dose of study drug and for 3 months after chemo-immunotherapy. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, 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 (eg, FluMist®) are live attenuated vaccines and are not allowed.\n  * Participants on any dose of warfarin. Use of low molecular weight heparin, antithrombin agents, anti-platelet agents or factor Xa inhibitors is allowed\n  * Participants may not use any other live biotherapeutic products (LBP) or supplementary use of probiotics in pill form during their participation in the study (e.g., Ferring's Rebyota, Vowst)\n* Participants may not be currently participating in or participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n* Known allergy to any of the components within the study agents and\u002For their excipients (i.e., corn starch, lactose, microcrystalline cellulose, croscarmellose sodium or magnesium stearate).\n* Medical history and concurrent diseases:\n\n  * Any prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least five years\n  * Known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (Note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention\n  * History of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n  * Known history of active TB (Mycobacterium tuberculosis)\n* Intercurrent or historic medical condition that increases subject risk in the opinion of the Investigator. Eligibility may be revisited for intercurrent medical conditions once resolution\u002Frecovery is deemed adequate by the investigator (e.g., recovery from major surgery, completion of treatment for severe infection).\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Has had an allogenic tissue\u002Fsolid organ transplant.","18 Years",{"count":107,"type":20},50,[24],"This is a single-arm and single site phase II trial combination of chemotherapy and pembrolizumab with LBP MO-03 in 50 trial participants with early triple negative breast cancer. MO-03 will be given at a dose of 4 x 10e9 CFU per capsule, 1 capsule taken orally twice daily. Patients will receive standard of care pembrolizumab 200 mg every 3 weeks in concurrent with a regimen of chemotherapy. Please refer to Table 2 for a summary of the chemo-immunotherapy with pembrolizumab containing regimens. Patients will continue to take MO-03 up until the day prior to surgery (lumpectomy or mastectomy). Post-surgery, patients will come in for a 2-week follow-up and then enter survival follow-up annually for 5 years.",[111,49,112],"TNBC - Triple-Negative Breast Cancer","Early Stage Triple-Negative Breast Carcinoma",[114,115,49,116],"Pembrolizumab","Neoadjuvant Chemo-Immunotherapy","High-risk early stage TNBC","NOT_YET_RECRUITING","2026-06-19",{"date":87,"type":90},{"date":121,"type":20},"2026-09",{"date":123,"type":20},"2035-09",{"name":125,"class":126},"Yuan Yuan","OTHER",3,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":21,"phases":137,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":158},"100483897","phase-1-a-study-to-evaluate-the-safety-pharmacokinetics-and-activity-of-enzelkitug-as-a-single-agent-and-in-combination-with-checkpoint-inhibitor-in-participants-with-locally-advanced-or-metastatic-solid-tumors-100483897","NCT05581004","A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors","A Phase Ia\u002FIb, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Life expectancy of at least 12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)\n* Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy\n* Tumor specimen availability\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding or intention of becoming pregnant during the study or within 4 months after the final dose of enzelkitug, or 4 months after the final dose of pembrolizumab, or 5 months after the final dose of atezolizumab\n* Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and\u002For radiotherapy, within 3 weeks prior to initiation of study treatment\n* Active hepatitis B (HBV) or hepatitis C (HCV) or tuberculosis\n* Positive test for human immunodeficiency virus (HIV) infection\n* Acute or chronic active Epstein-Barr virus (EBV) infection at screening\n* Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first enzelkitug infusion\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases\n* Active or history of autoimmune disease\n* Prior allogeneic stem cell or organ transplantation",{"count":136,"type":20},450,[23],"This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of enzelkitug when administered as a single agent and in combination with atezolizumab or pembrolizumab in adult participants with locally advanced or metastatic solid tumors, including non small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, colorectal cancer (CRC), urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.",[140,44,141,142,49,143,144,145,35,146,147,148],"Locally Advanced or Metastatic Solid Tumors","HNSCC","Melanoma","Esophageal Cancer","Gastric Cancer","Cervical Cancer","Urothelial Carcinoma","Clear Cell RCC","HCC","2026-06-05",{"date":151,"type":90},"2026-06-09",{"date":153,"type":90},"2022-10-20",{"date":155,"type":20},"2028-07-31",{"name":157,"class":97},"Genentech, Inc.",41,{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":165,"enrollmentInfo":166,"targetDuration":4,"studyType":21,"phases":168,"briefSummary":170,"conditions":171,"keywords":174,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":180,"leadSponsor":182,"locationsCount":184},"100638471","a-prospective-multicenter-phase-ii-clinical-study-of-postoperative-chemotherapy-combined-with-ql1706-for-high-risk-triple-negative-breast-cancer-100638471","NCT07622836","A Prospective, Multicenter, Phase II Clinical Study of Postoperative Chemotherapy Combined With QL1706 for High-risk Triple-negative Breast Cancer.","Inclusion Criteria:\n\n1. The participant voluntarily joins this study and signs the informed consent form.\n2. Female breast cancer participants aged ≥18 and ≤75 years, with a histologically or cytologically confirmed diagnosis of TNBC (IHC 0, IHC 1+, or IHC 2+\u002FISH-) based on the most recent biopsy or other pathological specimen, according to the latest ASCO\u002FCAP guidelines. Patients with low ER or PR expression (1%-10%) may also be included in this study.\n3. Patients with high-risk TNBC (defined as lymph node-positive).\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Agree to provide intraoperatively obtained tumor histopathological specimens (FFPE, at least 5 sections) for biomarker testing.\n6. Expected survival ≥3 months.\n7. Function of vital organs meets the following requirements (use of any blood components or cell growth factors within 14 days before the first dose is not allowed):\n\n   * Absolute neutrophil count ≥1.5×10⁹\u002FL;\n   * Platelet count ≥100×10⁹\u002FL;\n   * Hemoglobin ≥90 g\u002FL;\n   * Serum albumin ≥30 g\u002FL;\n   * Thyroid-stimulating hormone (TSH) ≤1×ULN (if abnormal, FT3 and FT4 levels should also be assessed; if FT3 and FT4 are within normal range, the patient may be enrolled);\n   * Serum total bilirubin ≤1.5×ULN;\n   * ALT and AST ≤2.5×ULN; in the presence of liver metastases, ALT and AST ≤5×ULN;\n   * ALP ≤2.5×ULN (in patients with liver or bone metastases, ALP ≤5×ULN);\n   * Serum creatinine ≤1.5×ULN;\n   * International normalized ratio (INR) ≤1.5×ULN (not receiving anticoagulation therapy).\n8. Female participants who are not surgically sterilized or are of childbearing potential must use a medically approved contraceptive method (such as an intrauterine device, contraceptive pill, or condom) during the study treatment period and for 3 months after the end of the study treatment. Female participants of childbearing potential who are not surgically sterilized must have a negative serum or urine HCG test within 7 days before the first dose and must not be lactating.\n\nExclusion Criteria:\n\n1. Presence of any active autoimmune disease or history of autoimmune disease (e.g., including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism); however, participants with the following conditions are allowed to enroll: vitiligo, psoriasis, alopecia not requiring systemic treatment; well-controlled type I diabetes mellitus; hypothyroidism stable on hormone replacement; childhood asthma that has completely resolved and requires no intervention in adulthood; asthma requiring bronchodilators for medical intervention is excluded.\n2. Current use of immunosuppressants or systemic corticosteroid therapy for immunosuppressive purposes (dose \\>10 mg\u002Fday prednisone or equivalent) within 2 weeks prior to enrollment.\n3. History of severe hypersensitivity reaction to other monoclonal antibodies.\n4. Prior discontinuation of anti-PD-1\u002FPD-L1 antibody therapy due to related toxicity.\n5. Known history or evidence of interstitial lung disease or active non-infectious pneumonitis.\n6. History of CNS metastases or current central nervous system (CNS) metastases. Baseline imaging to rule out brain metastases is not mandatory. Patients with unknown CNS metastasis status but with any clinical signs suggestive of CNS metastases are eligible only if CT and\u002For MRI scans rule out CNS metastases.\n7. Previous history of other malignancies (except for patients with non-melanoma skin cancer or carcinoma in situ of the cervix, who are eligible; patients with other prior malignancies must have been disease-free for at least 3 years).\n8. Hypertension poorly controlled with antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg); achieving the above parameters with antihypertensive treatment is allowed. History of hypertensive crisis or hypertensive encephalopathy.\n9. Within 6 months before first dose, known history of unstable angina, myocardial infarction (MI), or chronic heart failure (CHF), or known history of clinically significant arrhythmia requiring antiarrhythmic therapy (except stable atrial fibrillation), or left ventricular ejection fraction \\\u003C50%.\n10. Current thrombolytic or anticoagulant therapy; prophylactic use of low-dose aspirin or low-molecular-weight heparin is permitted.\n11. Presence of pleural effusion, ascites, or pericardial effusion requiring drainage; patients may be enrolled if clinically stable after drainage as assessed by the investigator.\n12. Arterial\u002Fvenous thrombotic events occurring within 6 months before enrollment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.\n13. Major vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months before start of study treatment.\n14. Major surgery (excluding diagnostic procedures) within 4 weeks before start of study treatment, or anticipated need for major surgery during the study.\n15. Urinalysis showing urine protein ≥++ and confirmed 24-hour urine protein \\>1.0 g.\n16. Prior radiotherapy (except palliative radiotherapy for bone lesions), chemotherapy, or surgery (except biopsy) with completion (last dose) less than 4 weeks before the first study dose; last dose of antibody therapy less than 4 weeks before first study dose; molecular targeted therapy (including oral targeted drugs from other clinical trials) less than 5 half-lives before first study dose, or adverse reactions from prior treatment (excluding alopecia) not recovered to ≤CTCAE grade 1.\n17. Active infection, unexplained fever ≥38.5°C within 7 days before dosing, or baseline white blood cell count \\>15×10⁹\u002FL.\n18. Congenital or acquired immunodeficiency (e.g., HIV infection); hepatitis B surface antigen (HBsAg) positive with HBV DNA ≥2000 IU\u002FmL; or hepatitis C virus antibody positive.\n19. Prior treatment with immune checkpoint inhibitors such as anti-PD-1, PD-L1, or anti-CTLA-4.\n20. Receipt of live vaccine within 4 weeks before first study dose or possible vaccination during the study period.\n21. As judged by the investigator, any other condition that may affect the study results or cause forced premature termination of the study, such as alcoholism, drug abuse, other serious diseases (including psychiatric illness) requiring concomitant treatment, severe laboratory abnormalities, or family\u002Fsocial factors that may affect patient safety.\n22. Women who are pregnant or breastfeeding.","75 Years",{"count":167,"type":20},59,[169],"NA","This study is a prospective, multicenter, phase II clinical trial designed to evaluate the efficacy and safety of postoperative chemotherapy combined with QL1706 in patients with high-risk triple-negative breast cancer.\n\nAfter enrollment, participants will receive 8 cycles of chemotherapy combined with QL1706. The standard chemotherapy regimen is the AC-T regimen (4 cycles of epirubicin plus cyclophosphamide, followed by 4 cycles of a taxane) - a Category I recommendation in the 2025 CSCO guidelines. The final choice of chemotherapy regimen is at the investigator's discretion. Starting from cycle 9, participants will receive QL1706 monotherapy as maintenance treatment. Dosing will continue until protocol-defined treatment discontinuation criteria are met, the participant experiences intolerable toxicity, or the participant withdraws informed consent. The maximum number of QL1706 dosing cycles is 17.\n\nAfter completing treatment, participants will continue to undergo post-treatment safety follow-up and survival follow-up. For participants who discontinue treatment for reasons other than disease progression or death, tumor progression follow-up will also be conducted after treatment ends.\n\nAfter enrollment, safety assessments will be performed every 3 weeks, and imaging evaluations will be performed every 12 weeks (±7 days) until confirmed disease progression per RECIST v1.1, initiation of another new anti-cancer therapy, withdrawal of informed consent, or death, whichever occurs first.",[49,172,173],"Adjuvant Therapy","Lymph Node Positive",[49,175],"QL1706","2026-06-02",{"date":178,"type":90},"2026-06-03",{"date":149,"type":20},{"date":181,"type":20},"2030-12-31",{"name":183,"class":126},"The First Affiliated Hospital with Nanjing Medical University",1,{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":21,"phases":194,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":184},"100640060","phase-2-sac-tmt-combined-with-bevacizumab-in-tnbc-with-brain-metastases-100640060","NCT07623577","Sac-TMT Combined With Bevacizumab in TNBC With Brain Metastases","An Open-label, Single-arm, Multi-center Phase II Study of Sacituzumab Tirumotecan (Sac-TMT) Combined With Bevacizumab in Triple-negative Breast Cancer Patients With Brain Metastases","Inclusion Criteria:\n\n1. Age ≥ 18 years old, regardless of gender;\n2. ECOG Performance Status of 0-2;\n3. Histologically or cytologically confirmed HR-negative and HER2-negative breast cancer; there is evidence of metastasis; not suitable with curative surgery or radiation therapy; HR negative is defined as: ER-negative and PR-negative, the proportion of positively stained tumor cells in all tumor cells is \\\u003C 10%; HER2- negative is defined as: histologically confirmed to be HER2 IHC (0) or HER2 IHC(1+) or HER2 IHC (2+) and FISH(-);\n4. MRI confirmed brain metastases, at least one intracranial parenchymal metastatic lesion with a longest diameter ≥ 1.0 cm without prior radiotherapy; For lesions with prior radiotherapy, progressive disease post radiotherapy must be confirmed by MRI\n5. Any conditions deemed by the investigator to make the patient unnecessary for local therapy;\n6. Life-expectancy ≥ 3 months;\n7. Intraventricular catheter shunt to reduce intracranial pressure or treatment with mannitol, hormones, and anticonvulsants was permitted prior to the first dose, but the dose of medication was stable for at least one week without increment and neurological symptoms were stable for ≥1 week;\n8. Adequate function of major organs meets the following requirements:\n\n(1)Blood routine: ANC≥1.5×109\u002FL; PLT≥75×109\u002FL; Hb ≥90 g\u002FL(Allows blood transfusion or the use of medication to ensure that the content of hemoglobin) ; (2)Coagulation: INR≤1.5; APTT≤1.5×ULN ; (3)Blood biochemistry：TBIL≤1.5 × ULN; ALT and AST≤3 × ULN (liver metastasis≤5.0 × ULN); Urea nitrogen ≤1.5 × ULN; Cr≤1.5 × ULN or creatinine clearance ≥50 mL \u002F min (Cockcroft-Gault formula) ; (4)Cardiac ultrasound: LVEF≥50%; (5)12-lead ECG: females QTcF interval \\\u003C 470 ms and males \\\u003C 450 ms; 9. Willing to join the study, sign informed consent, have good compliance and can cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Pial metastases confirmed by MRI or lumbar puncture;\n2. Presence of third interstitial fluid that cannot be controlled by drainage or other methods (e.g., a large amount of pleural effusion and ascites);\n3. Whole brain radiotherapy, chemotherapy, biological targeted therapy, immunotherapy, surgery or endocrine therapy within 2 weeks prior to enrolment;\n4. Prior use of bevacizumab or other anti-angiogenic agents is prohibited, except for the following scenarios:a)No disease progression occurred during bevacizumab treatment, no confirmed drug resistance was identified, and the investigator deems continued use beneficial for the participant;b)Short-course bevacizumab was administered solely for the management of cerebral edema\n5. Has received prior therapy with topoisomerase I inhibitors and ADC drugs regardless of targeting any target;\n6. Participation in any other clinical trials 2 weeks before enrollment;\n7. Strong inhibitors or inducers of CYP3A4 are not permitted during the study, which includes the 4-week period prior to the first administration.\n8. Concurrent use of any other Anti-cancer drugs;\n9. Bleeding tendency such as acute gastrointestinal bleeding, persistent bleeding disease or coagulation dysfunction;\n10. Other malignancies within 5 years, except cured in-situ of uterine cervix carcinoma , skin basal cell carcinoma and squamous-cell carcinoma;\n11. History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid treatment, a current ILD or non-infectious pneumonia, or a suspected ILD or non-infectious pneumonia that could not be ruled out by imaging at the time of screening; Clinically severe lung impairment due to co-occurring lung disease, including but not limited to any underlying lung disease (pulmonary embolism, 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 , or prior total pulmonary resection;\n12. History of severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or corneal disease that interferes with delayed corneal healing;\n13. Severe infection within 4 weeks prior to initial dosing, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; Active infections requiring systemic anti-infective therapy were present within 2 weeks prior to initial administration;\n14. History of heart disease:\n\n    1. Arrhythmias requiring medical treatment or of clinical significance;\n    2. Myocardial infarction;\n    3. Heart failure;\n    4. Any heart diseases that investigator believes not suitable for this study;\n15. History of allergy or hypersensitivity to any of the study drugs or study drug components;\n16. History of immunodeficiency including HIV-positive, active hepatitis B\u002FC, other acquired, congenital immunodeficiency disease or history of organ transplantation;\n17. A clear history of neurological or mental disorders, including epilepsy or dementia;\n18. According to the investigators' judgment, there is a concomitant disease that seriously endangers the safety of subjects or affects the completion of the study (including but not limited to severe hypertension, severe diabetes, active infection, thyroid disease that cannot be controlled by drugs);\n19. Pregnant or breastfeeding women. Women of childbearing potential who have a positive pregnancy test or unwilling to use adequate contraception prior to enrollment and for the duration of study participation;\n20. Any condition which in the investigators' opinion makes the subjects unsuitable for the study participation.",{"count":193,"type":20},24,[24],"This is a single-arm, multi-center phase II study to evaluate the safety and efficacy Sacituzumab Tirumotecan (Sac-TMT) plus bevacizumab in triple-negative breast cancer patients with brain metastases. Twenty-four participants are planned to be enrolled. The eligible patients should have histologically or cytologically confirmed TNBC with BM.",[49,197],"Brain Metastasis",[199,200,201,49,202],"trop2","Bevacizumab","Sacituzumab Tirumotecan","brain metastasis","2026-05-28",{"date":178,"type":90},{"date":206,"type":90},"2026-01-01",{"date":208,"type":20},"2027-12",{"name":210,"class":126},"Fudan University",{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":217,"phases":4,"briefSummary":218,"conditions":219,"keywords":221,"overallStatus":224,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":228,"locationsCount":184},"100634217","an-open-label-multicenter-non-randomized-expanded-access-protocol-eap-designed-to-provide-leronlimab-to-patients-with-locally-advanced-or-metastatic-triple-negative-breast-cancer-mtnbc-100634217","NCT07536815","An Open-Label, Multicenter, Non-Randomized Expanded Access Protocol (EAP) Designed to Provide Leronlimab to Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer (mTNBC)","Inclusion Criteria:\n\n* Adult participants \\> 18 years of age.\n* Histologically confirmed HR-\u002FHER2- metastatic TNBC using ASCO\u002FCAP criteria, Stage IIIB-IV.\n* Must have experienced disease progression on prior standard of care (SoC) therapy, be ineligible for SoC due to intolerance or contraindications, or have no remaining SoC treatment options available.\n* Be willing to provide tissue from a newly obtained core or excisional biopsy of an accessible tumor lesion if archival tissue is not available.\n* Must not be eligible for or able to enroll in any trials investigating leronlimab that are currently recruiting.\n* Participant must have adequate organ and bone marrow function within 14 days prior to enrollment as determined by the investigator.\n* ECOG performance status 0-2.\n* Participants of childbearing potential (POCBP) and males must agree to use two medically accepted methods of contraception with hormonal or barrier method of birth control, or abstinence, prior to study entry, for the duration of study participation and 4 months after the last dose of study drug.\n* Willingness and ability to comply with protocol requirements and attend follow-up visits.\n* Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study.\n\nExclusion Criteria:\n\n* Participants who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (PRO 140) are not eligible.\n* Have known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Note: Subjects with previously treated\u002Fstable brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline) and have no evidence of new or enlarging brain metastases. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.\n* Any uncontrolled concurrent illness (e.g., infection, heart failure) that, in the investigator's judgment, would interfere with the patient's ability to safely receive treatment. Note: Patients must complete any treatment with antibiotics prior to registration.\n* Concurrent participation in another interventional clinical trial.\n* Pregnant or breastfeeding women.\n* Any condition that, in the investigator's judgment, would interfere with the patient's ability to safely receive treatment.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.","EXPANDED_ACCESS","This Expanded Access Program provides investigational access to leronlimab (PRO 140) for patients with advanced or metastatic triple-negative breast cancer (TNBC) who lack satisfactory treatment options and are unable to participate in a clinical trial.",[49,111,220],"TNBC, Triple Negative Breast Cancer",[222,223],"leronlimab","PRO 140","AVAILABLE","2026-04-23",{"date":227,"type":90},"2026-04-27",{"name":229,"class":97},"CytoDyn, Inc.",{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":21,"phases":239,"briefSummary":240,"conditions":241,"keywords":242,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":256},"100594302","phase-2-phase-ii-trial-of-ivonescimab-in-combination-with-carboplatin--docetaxel-in-patients-with-early-stage-triple-negative-breast-cancer-100594302","NCT07017673","Phase II Trial of Ivonescimab in Combination With Carboplatin + Docetaxel in Patients With Early-Stage Triple Negative Breast Cancer","Phase II Trial of Ivonescimab in Combination With Carboplatin + Docetaxel in Patients With Early Stage Triple Negative Breast Cancer","Inclusion Criteria\n\n* Age ≥ 18 years of age\n* ECOG ≤ 1\n* High-risk early stage triple negative breast cancer (TNBC), defined by ER≤10%, PR≤10% and HER2 negative (by IHC or FISH), per ASCO\u002FCAP guidelines\n* Clinically ≥T1cN0, or any T, N1-2\n* Plan to receive neoadjuvant chemotherapy and immune checkpoint inhibitor before surgery as standard-of-care treatment\n* Adequate organ function as defined in the following. Specimens must be collected within 14 days prior to the start of study treatment.\n\n  * ANC ≥ 1,500\u002Fmm3\n  * Platelets ≥ 100,000\u002Fmm3\n  * Hemoglobin ≥ 9.0 g\u002FdL.\n  * Total serum bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 x ULN\n  * AST \\\u003C 3 x ULN\n  * ALT \\\u003C 3 x ULN\n  * Creatinine clearance ≥ 30 mL\u002Fmin\n  * INR or PT, aPTT \\\u003C 1.5 x ULN\n* Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test within 14 days of start of study treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Note: If egg harvesting was completed prior to enrollment, the pregnancy test may be falsely positive and the PI will assess and determine eligibility for these cases.\n* Female participants: A female participant is eligible to participate if she is not pregnant (see Appendix B), not breastfeeding, and at least one of the following conditions applies:\n\n  \\-- Not a woman of childbearing potential (WOCBP) as defined in Appendix B OR Females of child-bearing potential must be willing to use effective contraception during study and for 120 days after the last dose.\n* Male participants: A male participant must agree to use a contraception as detailed in Appendix B of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria\n\n* Evidence of metastatic disease.\n* Is currently participating in or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.\n* History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to start of study treatment, including but not limited to:\n\n  * Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots) Note: transient hemoptysis associated with diagnostic bronchoscopy is allowed.\n  * Nasal bleeding\u002Fepistaxis (bloody nasal discharge is allowed)\n  * Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable, in the opinion of the treating investigator, prior to start of study treatment is not allowed. The use of full-dose anticoagulants is permitted as long as the INR or activated partial thromboplastin time (aPTT) is within therapeutic limits according to the medical standard of the enrolling institution.\n* Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy\n* Women who are or are planning to become pregnant or breastfeed\n* Known allergy to any of the components within the study agents and\u002For their excipients\n* Medical history and concurrent diseases\n\n  * Autoimmune diseases\n  * Any prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least three years\n  * History of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n  * Active infection requiring systemic therapy\n  * Known history of Human Immunodeficiency Virus (HIV) infection\n  * Known history of 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. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority\n  * Known history of active TB (Mycobacterium tuberculosis)\n  * History of unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ grade 2) or unstable vascular disease (eg, aortic aneurysm at risk of rupture, Moyamoya disease) that required hospitalization within 12 months prior to randomization, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia)\n  * Prolongation of QTc interval \\>480 msec\n  * Prior allogeneic bone marrow transplantation or prior solid organ transplantation\n  * History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months prior to start of study treatment\n  * History of any grade arterial thromboembolic event, Grade 3 and above venous thromboembolic event, as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to start of study treatment\n  * Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before start of study treatment\n  * History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to start of study treatment\n* Prohibited Treatments and\u002For Therapies\n\n  * Other non-protocol specified anti-cancer therapy: systemic radiotherapy, immunotherapy, biologic, or hormonal therapy. tretinoin therapy, nitrosourea, mitomycin C, small molecule tyrosine kinase inhibitor therapy\n\n    \\--- Concomitant use of hormones for non-tumor-related conditions (e.g., insulin and hormone replacement therapy for diabetes mellitus) is acceptable\n  * Any live vaccine within 30 days prior to the first dose of study drug and up to 120 days after the last dose. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, 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 (eg, FluMist®) are live attenuated vaccines and are not allowed\n  * Prior systemic therapy or radiation therapy with curative intent for the current breast cancer\n  * A previous definitive ipsilateral breast surgery for the current breast cancer\n  * 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 (e.g. CTLA-4, OX-40, CD137).\n  * Immunosuppressive drugs, including, but not limited to, prednisone or equivalent, methotrexate, azathioprine, and TNF-α antagonists at doses exceeding 10 mg per day. The following exceptions are allowed:\n\n    * The use of immunosuppressive drugs for the treatment of study drug-associated AEs or the use of immunosuppressive drugs in subjects with contrast allergy is acceptable.\n    * The use of inhaled, topical, and intranasal glucocorticoids is permitted.\n    * Corticosteroids are allowed as a prophylactic drug for hypersensitivity reactions (eg, before CT or MRI).\n    * Corticosteroids are allowed as antiphylactic and therapeutic agents for chemotherapy-induced vomiting.\n    * Short-term use of glucocorticoids for underlying or intercurrent conditions may be permitted after discussion with the PI.\n* Major surgery within 28 days prior to start of study treatment and within 4 weeks after first dose. Participants must have fully recovered from the effects of prior major surgery in the opinion of the treating investigator.\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.",{"count":238,"type":20},34,[24],"This is a single arm phase II trial combination of ivonescimab and carbo-docetaxel every 3 weeks for 6 cycles in patients with early-stage triple negative breast cancer. The trial is designed to test the safety and efficacy of adding ivonescimab in patients with early TNBC undergoing neoadjuvant chemotherapy with carboplatin and docetaxel. Patients will receive ivonescimab 20 mg\u002Fkg IV on Day 1 of each cycle, and carboplatin AUC6 and docetaxel 75 mg\u002Fm2 on Day 1 of each cycle for 6 cycles. Cycles will be 21 days for a total of 6 cycles. Curative intent surgery will be performed within 6 weeks (maximum 12 weeks) time frame upon completion of last dose of chemoimmunotherapy. The surgical pathology information will be used for assessment of pathological response, which serve as the primary endpoint of this study. Patients will undergo assessment at baseline, C1D1 of each cycle and end of treatment visit for collection of treatment-emergent adverse events, evaluated by CTCAE v5.0. Patient reported outcomes will be collected at cycles 1, 4, and 6, and at EOT. All study patients will be followed for at least 5 years for EFS and OS follow up. Research biopsies, peripheral blood and stool samples will be collected at the following time points: baseline, C4D1 (+\u002F-14 days), and surgery (+\u002F-14 days). Baseline and EOT breast MRI will be performed as standard of care for assessment of clinical response. Mid treatment breast ultrasound (C4D1 +\u002F-14 days) will be repeated as standard of care to assess clinical response to treatment. Mid-treatment C4D1 tumor biopsy may be omitted if the primary tumor is no longer visible or the tumor deemed too small for biopsy by radiologist.",[49,111,112],[243,244,245,246,49,116],"Ivonescimab","Carboplatin","Docetaxel","Neoadjuvant chemotherapy","2026-04-01",{"date":249,"type":90},"2026-04-02",{"date":251,"type":90},"2025-07-25",{"date":253,"type":20},"2032-11",{"name":255,"class":126},"Cedars-Sinai Medical Center",4,{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":263,"minAge":105,"maxAge":165,"enrollmentInfo":264,"targetDuration":4,"studyType":21,"phases":266,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":4},"100630757","a-single-arm-single-center-phase-ii-clinical-study-of-camrelizumab-combined-with-radiochemotherapy-as-neoadjuvant-therapy-for-early-stage-triple-negative-breast-cancer-100630757","NCT07491822","A Single-Arm, Single-Center, Phase II Clinical Study of Camrelizumab Combined With Radiochemotherapy as Neoadjuvant Therapy for Early-Stage Triple-Negative Breast Cancer","Inclusion Criteria:\n\n* Female patients aged ≥18 years and ≤75 years with treatment-naive breast cancer;\n* Histopathologically confirmed early-stage triple-negative invasive breast cancer as defined by the latest ASCO\u002FCAP guidelines, meeting all of the following criteria: Pathological subtype must be triple-negative, specifically: ER-negative: IHC \\\u003C1%, PR-negative: IHC \\\u003C1%, HER2-negative: IHC 0\u002F1+ or IHC 2+ but ISH-negative;\n* Primary triple-negative breast cancer patients with clinical staging cT1c-T4d and any cN status;\n* Center-assessed Ki67 and sTIL values;\n* Expected survival ≥ 3 months;\n* At least one measurable lesion present per RECIST 1.1 criteria;\n* Organ function levels must meet the following requirements: 1) Complete blood count (CBC) neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL (no hematopoietic growth factor use within 14 days prior to first study dose); White blood cell count (WBC) ≥3.0×10⁹\u002FL and ≤15×10⁹\u002FL; lymphocyte count (LC) ≥0.5×10⁹\u002FL; platelet count (PLT) ≥100×10⁹\u002FL (no blood transfusion within 14 days prior to first study dose) Hemoglobin (Hb) ≥90 g\u002FL; 2) Blood Biochemistry: TBIL ≤1.5×ULN; ALT and AST ≤2.5×ULN; ALP ≤2.5×ULN; BUN and Cr ≤1.5×ULN with creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault formula); INR and APTT ≤ 1.5×ULN (without anticoagulant therapy); Thyroid-stimulating hormone (TSH) ≤ upper limit of normal (ULN); if abnormal, assess T3 and T4 levels; inclusion permitted if T3 and T4 levels are normal; 3) Cardiac function: Echocardiogram: LVEF ≥ 50%; Lead ECG: QT interval, females \\\u003C 470 ms.\n* Contraception: Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to first dosing and agree to use a medically approved highly effective contraceptive method during the study and for 90 days after the last study drug administration. The investigator or designated personnel will select an appropriate contraceptive method for the subject and her partner from the options below after consultation, confirming the subject understands how to use it correctly and consistently. At the timepoints listed in the protocol, the investigator will notify the subject of the need for continuous, correct contraception. Additionally, the subject must be aware that they must immediately notify the investigator if they discontinue the selected contraceptive method or if they suspect or confirm pregnancy. A highly effective contraceptive method is one that, when used correctly and consistently alone or in combination with other methods, has an annual failure rate of less than 1%. These include the following: 1) Correct placement of an intrauterine device (IUD). 2) Condoms used in combination with a spermicide (i.e., foam, gel, film, cream, or suppository). 3) Bilateral tubal ligation\u002Fbilateral salpingectomy or bilateral tubal occlusion surgery (occlusion confirmed effective by relevant instrumentation). 4) Male vasectomy.\n* Voluntarily enrolled in this study, signed informed consent, demonstrated good compliance, and agreed to participate in follow-up visits.\n\nExclusion Criteria:\n\n* Tumor-Related Symptoms and Treatments\n\n  1. Patients with metastatic breast cancer or bilateral breast cancer;\n  2. Patients with inflammatory breast cancer;\n  3. Received any antitumor therapy within 12 months prior to signing the informed consent form, including chemotherapy, targeted therapy, radiotherapy, endocrine therapy, immunotherapy, biological therapy, or tumor embolization;\n  4. Previous treatment with PD-1\u002FPD-L1 antibodies, CTLA-4 antibodies, or other PD-1\u002FPD-L1 inhibitors;\n* Concurrent Diseases\u002FMedical History\n\n  1. Active malignancies within 5 years prior to or concurrent with informed consent. Patients with cured localized tumors such as basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, or cervical carcinoma in situ may be eligible.\n  2. Major non-breast cancer-related surgical procedures within 4 weeks prior to enrollment, or patients not yet fully recovered from such procedures (tissue biopsies for diagnostic purposes and peripheral intravenous catheter placement for central venous access \\[PICC\\] are permitted);\n  3. Subjects with any known or suspected autoimmune disease, except:\n\nHypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy; Subjects with stable, well-controlled type 1 diabetes mellitus; 4) Presence of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic disease (e.g., diabetes mellitus, pulmonary fibrosis, acute pneumonia); 5) History of live attenuated vaccine administration within 28 days prior to first study dose or anticipated live attenuated vaccine administration during the study period; 6) Human Immunodeficiency Virus (HIV) infection or known Acquired Immunodeficiency Syndrome (AIDS); Hepatitis B Virus Surface Antigen (HBsAg) positive, or Hepatitis B Core Antibody (HBcAb) positive followed by positive HBV-DNA test (HBV-DNA testing only for HBsAg negative and HBcAb positive patients) ; positive HCV-RNA test following positive HCV antibody test (HCV-RNA testing only performed in HCV antibody-positive patients); autoimmune hepatitis; 7) Severe infection within 4 weeks prior to first dosing, including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc.; or active infection of CTCAE ≥ Grade 2 requiring systemic antibiotic treatment within 2 weeks prior to first dosing; or unexplained fever \\>38.5°C during screening\u002Fprior to first dosing (fever attributable to tumor may be acceptable for enrollment at investigator's discretion) ; evidence of active tuberculosis infection within 1 year prior to dosing; 8) Subjects with a history of or scheduled for allogeneic bone marrow transplantation or solid organ transplantation; 9) Peripheral neuropathy ≥ Grade 2; 10) Severe cardiac disease or discomfort, including but not limited to: History of heart failure or systolic dysfunction (LVEF \\\u003C 50%); high-risk uncontrolled arrhythmias such as atrial tachycardia; resting heart rate \\>100 bpm; significant ventricular arrhythmias (e.g., ventricular tachycardia) or higher-degree atrioventricular block (i.e., Mobitz II second-degree AV block or third-degree AV block); coronary artery disease requiring antianginal medication; clinically significant valvular heart disease; ECG evidence of transmural myocardial infarction; poorly controlled hypertension (systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg);\n\n* Treatment-Related Exclusions\n\n  ① Subjects who received systemic immunostimulatory agents (including but not limited to interferon or interleukin-2, including investigational immunostimulants) within 4 weeks prior to the first dose;\n\n  ② Subjects who received systemic immunosuppressive therapy (including but not limited to glucocorticoids, azathioprine, methotrexate, thalidomide, anti-tumor necrosis factor agents) within 2 weeks prior to the first dose. Excludes intranasal or inhaled corticosteroids or physiologically dosed systemic steroids (i.e., physiologically dosed corticosteroids not exceeding 10 mg\u002Fday of prednisone or equivalent);\n\n  ③ Known allergy to the study drug or any of its excipients; or history of severe allergic reactions to other monoclonal antibodies;\n* Pregnant or lactating women; women of childbearing potential with a positive baseline pregnancy test; or women of childbearing potential unwilling to use effective contraception throughout the study period.\n* History of established neurological or psychiatric disorders, including epilepsy or dementia; subjects with known history of psychiatric drug abuse, alcoholism, or substance abuse;\n* Any other condition deemed by the investigator to make the patient unsuitable for participation in this study.","FEMALE",{"count":265,"type":20},43,[169],"Camrelizumab + Chemoradiotherapy for Early TNBC Sponsor\u002FLeading Center: Tianjin Medical University Cancer Institute and Hospital Study Type: Single-arm, single-center, Phase Ⅱ clinical study Planned Enrollment: 43 patients Eligible Population 18-75-year-old female patients with newly diagnosed, untreated early invasive triple-negative breast cancer (TNBC) (ER-\u002FPR-\u002FHER2- per ASCO\u002FCAP guidelines), clinical stage cT1c-T4d (any cN); central assessment of Ki67 and sTIL values, at least one measurable lesion (RECIST 1.1), normal major organ function, expected survival ≥3 months; negative pregnancy test (women of childbearing potential) with agreement to effective contraception; signed informed consent and good compliance.\n\nExclusion: Metastatic\u002Fbilateral\u002Finflammatory TNBC; prior anti-tumor\u002FPD-1\u002FPD-L1 treatment within 12 months; active other malignancies, autoimmune diseases, interstitial lung disease, uncontrolled severe infections\u002Fheart disease; pregnancy\u002Flactation; allergy to study drugs.\n\nStudy Design Treatment Regimen (Neoadjuvant + Individualized Follow-up)\n\nAll patients receive the same combined therapy, followed by surgery (with extended treatment for non-responders):\n\n12-week core neoadjuvant treatment: Camrelizumab (200mg IV, Q3W) + nab-paclitaxel (100mg\u002Fm² IV, weekly) + carboplatin (AUC=1 IV, weekly) + SBRT (10Gy × 2 sessions, on the 3rd day after chemotherapy in Week 3 and 6).\n\nPost-12-week evaluation \\& treatment:\n\nClinical responders: Undergo surgery within 3 weeks. Clinical non-responders: Continue with 12-week EC regimen (epirubicin 80mg\u002Fm² + cyclophosphamide 600mg\u002Fm², IV Q3W, 4 cycles) + camrelizumab, then surgery within 3 weeks.\n\nStudy Procedures Screening (≤28 days): Complete imaging, laboratory and physical examinations to confirm eligibility.\n\nTreatment period: Scheduled combined therapy with regular efficacy assessments (breast imaging every 2 cycles) and safety monitoring.\n\nFollow-up: Mandatory surgery after treatment; 90-day safety follow-up post-last dose, and long-term survival follow-up (q3m for Year 1, q6m thereafter) for 5 years.\n\nPrimary Outcome Pathological complete response (pCR, defined as ypT0\u002FTis ypN0: no residual invasive cancer in resected breast and sampled lymph nodes).",[49],"2026-03-19",{"date":271,"type":90},"2026-03-24",{"date":273,"type":20},"2026-03-25",{"date":275,"type":20},"2031-03-15",{"name":277,"class":126},"Tianjin Medical University Cancer Institute and Hospital",{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":11,"sex":263,"minAge":105,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":21,"phases":286,"briefSummary":287,"conditions":288,"keywords":289,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":4},"100626890","phase-2-a-phase-ii-single-arm-study-to-evaluate-the-efficacy-and-safety-of-inavolisib-in-combination-with-eribulin-in-pretreated-advanced-triple-negative-breast-cancer-harboring-a-pik3ca-mutation-100626890","NCT07441512","A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Eribulin in Pretreated Advanced Triple-negative Breast Cancer Harboring a PIK3CA Mutation","Inclusion Criteria:\n\n* Patients must meet the following criteria for study entry:\n\n  * Signed Informed Consent Form\n  * Female participants who are at least 18 years of age on the day of signing informed consent\n  * Evaluable or measurable disease per RECIST v1.1\n  * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n  * Life expectancy of \\> 12 weeks\n  * Adequate hematologic and organ function within 14 days prior to initiation of study treatment, defined by the following:\n\n    * Absolute neutrophil count ≥ 1500\u002FμL\n    * Hemoglobin ≥ 9 g\u002FdL\n    * Platelet count ≥ 100,000\u002FμL\n    * Fasting glucose \\\u003C 126 mg\u002FdL or \\\u003C 7 mmol\u002FL and glycosylated hemoglobin (HbA1C) \\\u003C 6.5% or \\\u003C 48 mmol\u002Fmol\n    * Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (\\\u003C 3 × ULN if Gilbert's disease)\n    * Serum albumin ≥ 2.5 g\u002FdL or 25 g\u002FL\n    * AST and ALT ≤ 2.5 × ULN with the following exception:\n* Patients with documented liver metastases: AST and ALT ≤ 5.0 × ULN\n\n  o ALP ≤ 2.5 × ULN with the following exception:\n* Participants with documented liver or bone metastases: ALP ≤ 5.0 × ULN\n\n  o INR \\\u003C 1.5 × ULN and aPTT \\\u003C 1.5 × ULN\n* For participants requiring anticoagulation therapy with warfarin or similar agents (such as Vitamin K antagonists), a stable INR between 2 and 3 is required. If anticoagulation is required for a prosthetic heart valve, then stable INR between 2.5 and 3.5 is permitted.\n\n  * Creatinine clearance ≥ 60 mL\u002Fmin on the basis of the Cockcroft-Gault glomerular filtration rate estimation.\n\n    • Participants with controlled HBV infection are allowed if they have:\n  * Normal ALT levels\n  * Positive hepatitis B surface antigen (HbsAg) and negative total hepatitis B core antibody (HbcAb) or positive HbcAb and\n  * HBV DNA ≤ 2000 UI\u002FmL\n* They are under antiviral treatment following local guidelines. Prophylactic treatment and follow-up must be done by a specialized physician per local SoC. The overall potential benefits associated with study treatment should be deemed to exceed the overall risks by the investigator\n\n  * Negative hepatitis C virus (HCV) antibody test at screening, or a positive HCV antibody test followed by a negative HCV RNA test at screening\n  * Histologically or cytologically documented adenocarcinoma of the breast that is locally advanced or metastatic, not amenable to surgical or radiation therapy with curative intent\n\n    * Documented HR-negative tumor in accordance with American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines31, defined as \\\u003C 1% of tumor cells staining positive for estrogen receptor (ER) and progesterone receptor (PgR), as per the most recently available local assessment.\n    * Documented HER2-negative tumor in accordance with ASCO\u002FCAP guidelines, defined as a HER2 immunohistochemistry (IHC) score of 0 or 1+ , or an IHC score of 2+ accompanied by a negative fluorescence, chromogenic, or silver in situ hybridization test indicating absence of HER2 gene amplification, or a HER2\u002FCEP17 ratio of \\\u003C 2.0, based on the most recently available local assessment.\n  * Have progressed after at least one line of systemic therapy in advanced setting.\n\n    o Patients who received chemotherapy or antibody-drug conjugate (ADC), either with or without a checkpoint inhibitor treatment, in advanced setting are eligible for enrollment\n  * Consent to provide fresh (preferred) or archival tumor tissue specimen, and freshly collected pretreatment blood sample. It is preferred that the specimen be from the most recently collected and available tumor tissue, and whenever possible, from a metastatic site of disease. Archival tumor tissue is defined as tumor tissue that was collected prior to the participant being (pre)screened for the study, and it can be from either the metastatic disease (preferred) or the primary tumor. See Section 8.2.8 for specimen requirements.\n  * Confirmation of biomarker eligibility: valid results from central testing of tumor tissue documenting the presence of a study-eligible PIK3CA mutation. Eligible PIK3CA mutations are defined as follows (71 PIK3CA mutations): H1047D\u002FI\u002FL\u002FN\u002FP\u002FQ\u002FR\u002FT\u002FY G1049A\u002FC\u002FD\u002FR\u002FS E545A\u002FD\u002FG\u002FK\u002FL\u002FQ\u002FR\u002FV E453A\u002FD\u002FG\u002FK\u002FQ\u002FV E542A\u002FD\u002FG\u002FK\u002FQ\u002FR\u002FV K111E\u002FN\u002FR Q546E\u002FH\u002FK\u002FL\u002FP\u002FR G106A\u002FD\u002FR\u002FS\u002FV N345D\u002FH\u002FI\u002FK\u002FS\u002FT\u002FY G118D C420R R88Q M1043I\u002FT\u002FV N1044H\u002FI\u002FK\u002FS\u002FT\u002FY T1025A\u002FI\u002FS The central test for identification of eligible PIK3CA mutations is the whole exome sequencing performed at Sponsor-designated central testing laboratory.\n  * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a highly effective form of contraceptive method (non-hormonal) with a failure rate of \\\u003C 1% per year in combination with use of male condom with spermicide (for male partners), unless male sterilization has been confirmed. Agreement to refrain from donating eggs during the treatment period and for at least 60 days after the last dose of inavolisib and at least 3 months after the last dose of eribulin.\n\nA woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state ( ≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus).\n\nThe reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n\nExclusion Criteria:\n\n* Patients who meet any of the following criteria will be excluded from study entry:\n\n  * Pregnancy, lactation, or intention to become pregnant during the study\n\n    o Women of childbearing potential (including those who have had a tubal ligation) must have a negative pregnancy test result within 14 days prior to initiation of study treatment.\n  * Metaplastic breast cancer\n  * Radiotherapy within 4 weeks before Cycle 1 Day 1\n  * Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes\n  * Malabsorption syndrome or other condition that would interfere with enteral absorption\n  * Inability or unwillingness to swallow pills\n  * Any history of leptomeningeal disease or carcinomatous meningitis\n  * Known and untreated, or active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible, provided they meet all of the following criteria:\n\n    * Measurable or evaluable disease (per RECIST v1.1) outside the CNS\n    * No ongoing requirement for corticosteroids as therapy for CNS metastases, with corticosteroids discontinued for ≥ 2 weeks prior to enrollment and no ongoing symptoms attributed to CNS metastases\n    * Radiographic demonstration of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study\n    * The screening CNS radiographic study is ≥ 4 weeks since completion of radiotherapy\n    * No history of intracranial hemorrhage or spinal cord hemorrhage\n  * Pleural effusion, pericardial effusion, or ascites requiring drainage procedures every 14 days or more frequently\n\n    o Indwelling pleural or abdominal catheters may be allowed, provided the patient has adequately recovered from the procedure, is hemodynamically stable and symptomatically improved.\n  * Symptomatic hypercalcemia requiring continued use of bisphosphonate or denosumab therapy\n\n    o Bisphosphonate and denosumab therapy for bone metastases or osteopenia\u002Fosteoporosis is allowed.\n  * Any active infection that, in the opinion of the investigator, could impact patient safety; or serious infection requiring intravenous (IV) antibiotics within 7 days prior to Day 1 of Cycle 1\n  * Active inflammatory (e.g., uveitis or vitritis) or infectious (e.g., conjunctivitis, keratitis, scleritis, or endophthalmitis) conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye\n  * Requirement for daily supplemental oxygen\n  * Symptomatic active lung disease that is not specifically due to underlying breast cancer, including pneumonitis\n  * Active tuberculosis\n  * History of or active inflammatory disease (e.g., Crohn's disease or ulcerative colitis), or any active bowel inflammation (including diverticulitis)\n\n    o Patients currently receiving immunosuppressants (e.g., sulfasalazines) are considered to have active disease and are thus ineligible.\n  * Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study\n  * Prior hematopoietic stem cell or bone marrow transplantation, or radiation therapy encompassing \\> 30% of marrow\n  * Unresolved toxicity \\> Grade 1 from prior cancer therapy, except for:\n\n    * Hot flashes and alopecia (may be any grade)\n    * Peripheral neuropathy (may be up to Grade 1)\n  * Significant traumatic injury or major surgical procedure within 4 weeks prior to initiation of study treatment, or planned surgery during the study\n  * Positive HIV test at screening\n  * Clinically significant history of liver disease, including severe liver impairment (ChildPugh Class B\u002FC), active viral or other hepatitis, current alcohol abuse, or cirrhosis\n\n    o Patients with active HBV infection defined as: positive HbsAg, positive HbcAb, HBV DNA \\> 2000 UI\u002FmL, and\u002For elevated ALT levels\n  * History of malignancy within 5 years prior to consent, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer\n  * History or presence of an abnormal ECG that is deemed clinically significant, (e.g., complete left bundle branch block, second- or third-degree atrioventricular heart block) or evidence of prior myocardial infarction\n  * History of or active clinically significant cardiovascular dysfunction, including the following:\n\n    * History of stroke or transient ischemic attack within 6 months prior to first dose of study treatment\n    * History of myocardial infarction within 6 months prior to first dose of study treatment\n    * New York Heart Association Class III or IV cardiac disease or congestive heart failure requiring medication\n    * Uncontrolled arrhythmias, history of or active ventricular arrhythmia requiring medication\n    * Coronary heart disease that is symptomatic or unstable angina\n    * Congenital long QT syndrome or QT interval corrected with Fridericia's formula (QTcF) \\> 470 ms demonstrated by at least two ECGs \\> 30 minutes apart, history of long or short QT syndrome, Brugada syndrome or known history of corrected QT interval prolongation, or torsades de pointes.\n  * Known allergy or hypersensitivity to any of the study drugs or any of their excipients\n  * Patients with any of the following prior treatment histories are excluded:\n\n    * Prior treatment with PARP inhibitors for advanced TNBC\n    * Progressed solely on endocrine therapy or HER2-targeted therapy without prior chemotherapy for advanced TNBC\n    * Treatment with investigational therapy within 28 days prior to initiation of study treatment\n    * Prior treatment with any of the PI3K, AKT, or mTOR inhibitor or with eribulin",{"count":285,"type":20},26,[24],"This is an open-label, Simon's optimal two-stage design, single-arm, Phase II study with first 6 patients in the safety run-in portion. PIK3CAmut advanced triple-negative breast cancer(TNBC) patients who have progressed on at least one prior line of systemic therapy in advanced setting will be enrolled to receive inavolisib plus eribulin treatment. The study is carried out in two stages. In Stage One, 10 patients are accrued. If there are 4 or more responses among these 10 patients and positive recommendation by the safety review meeting based on the evaluation of first 6 safety run-in patients' data, additional 16 patients will be accrued in Stage Two, resulting in a total patient number of 26. Otherwise, the study will be terminated and a report will be prepared outlining the observed data and the rationale for termination.",[111,49],[290,49],"ML46206","2026-02-27",{"date":293,"type":90},"2026-03-02",{"date":295,"type":20},"2026-03-15",{"date":297,"type":20},"2028-03-15",{"name":299,"class":126},"Hu Hai",{"id":301,"slug":302,"hasResults":11,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":306,"eligibilityCriteria":307,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":4,"enrollmentInfo":308,"targetDuration":4,"studyType":21,"phases":310,"briefSummary":311,"conditions":312,"keywords":324,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":349},"100568558","phase-1-a-study-to-evaluate-the-safety-and-efficacy-of-a2b395-an-allogeneic-logic-gated-car-t-in-participants-with-solid-tumors-that-express-egfr-and-have-lost-hla-a02-expression-100568558","NCT06682793","A Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated CAR T, in Participants With Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression","A Seamless Phase 1\u002F2 Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated Tmod™ CAR T, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression","DENALI-1","Inclusion Criteria:\n\nKey Inclusion Criteria:\n\n1. Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A\\*02 by NGS (whenever possible from the primary site).\n2. Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, HNSCC, TNBC, RCC, or other solid tumors with EGFR expression. Measurable disease is required with lesions of ≥1.0 cm by CT.\n3. Received previous required therapy for the appropriate solid tumor disease as described in the protocol\n4. Has adequate organ function as described in the protocol\n5. ECOG performance status of 0 to 1\n6. Life expectancy of ≥3 months\n7. Willing to comply with study schedule of assessments including long-term safety follow-up\n\nKey Exclusion Criteria:\n\n1. Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative\n2. Prior allogeneic stem cell transplant\n3. Prior solid organ transplant\n4. Cancer therapy within 3 weeks or 3 half lives of A2B395 infusion\n5. Radiotherapy within 28 days of A2B395 infusion\n6. Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months\n7. Any new symptomatic pulmonary embolism (PE) or a deep vein thrombosis (DVT) within 3 months of enrollment. Therapeutic dosing of anticoagulants is allowed for history of PE or DVT if greater than 3 months from time of enrollment, and adequately treated\n8. History of interstitial lung disease including drug-induced interstitial lung disease and radiation pneumonitis that requires treatment with prolonged steroids or other immune suppressive agents within 1 year\n9. Requires supplemental home oxygen\n10. Females of childbearing potential who are pregnant or breastfeeding\n11. Subjects, both male and female, of childbearing potential who are not willing to practice birth control from the time of consent through 6 months post infusion of A2B395",{"count":309,"type":20},240,[23,24],"The goal of this study is to test A2B395, an allogeneic logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC) and other solid tumors that express EGFR and have lost HLA-A\\*02 expression.\n\nThe main questions this study aims to answer are:\n\n* Phase 1: What is the recommended dose of A2B395 that is safe for patients\n* Phase 2: Does the recommended dose of A2B395 kill the solid tumor cells and protect the patient's healthy cells\n\nParticipants will be required to perform study procedures and assessments, and will also receive the following study treatments:\n\n* Enrollment in BASECAMP-1 (NCT04981119)\n* Preconditioning lymphodepletion (PCLD) regimen\n* A2B395 Tmod CAR T cells at the assigned dose",[313,35,314,45,315,316,317,31,318,319,141,320,321,322,48,49,323],"Solid Tumor, Adult","Non-Small Cell Lung","Cancer","Colon Cancer","Rectal Cancer","CRC","Head and Neck Squamous Cell Cancer","Renal Cell Carcinoma","RCC","Kidney Cancer","Colorectal Adenocarcinoma",[325,326,327,328,329,330,331,318,332,333,334,335,315,44,336,31,337,321,322,338,339,49],"CAR T Cell","Solid Tumors","Allogeneic","T Cell","EGFR","HLA-A2","Solid tumors expressing EGFR","Colorectal","Cell Therapy","Gene Therapy","Blocker","Non small Cell Lung Cancer","renal cell carcinoma","Renal cell cancer","Triple negative breast cancer","2025-09-03",{"date":342,"type":90},"2025-09-09",{"date":344,"type":90},"2025-05-22",{"date":346,"type":20},"2030-03-31",{"name":348,"class":97},"A2 Biotherapeutics Inc.",10,{"id":351,"slug":352,"hasResults":11,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":356,"eligibilityCriteria":357,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":21,"phases":360,"briefSummary":361,"conditions":362,"keywords":368,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":184},"100575218","phase-1-hs-10502-combination-treatment-in-patients-with-advanced-solid-tumors-100575218","NCT06769425","HS-10502 Combination Treatment in Patients With Advanced Solid Tumors","A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10502 Combination Treatment in Subjects With Advanced Solid Tumors","HS-10502","Inclusion Criteria:\n\n* Males or females aged 18 years or older (≥18 years).\n* Patients diagnosed with pathologically confirmed advanced solid tumors.\n* Subjects have at least one target lesion as assessed per the RECIST 1.1.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1 and no deterioration within 2 weeks before the first dose.\n* Have a life expectancy of at least 12 weeks.\n* Female subjects of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed from signing the informed consent until 6 months after the last dose; male subjects must agree to use barrier contraception (i.e. condoms) from signing the informed consent to 6 months after the last dose.\n* Female subjects must have a negative pregnancy test within 7 days prior to the first dose (for subjects with tumor related abnormal elevation of human chorionic gonadotropin \\[HCG\\], an ultrasound of uterus and appendages should be performed within 7 days prior to the first dose to rule out pregnancy), or demonstrate no risk for pregnancy.\n* Subject must be voluntarily enrolled in this clinical trial, be able to understand the study procedures and to sign written informed consent.\n\nExclusion Criteria:\n\n* Have received or is currently receiving the following treatment: PARPi\u002FB7-H4\u002FB7-H3-targeted therapies;\n* Have received or is currently receiving the following treatment: PARPi\u002FB7-H4\u002FB7-H3-targeted therapies;\n* Have received any of cytotoxic chemotherapy drugs, investigational drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within 14 days prior to the first dose of study drug; or need to continue these drugs during the study.\n* Presence of Grade ≥ 2 toxicities as per Common Terminology Criteria for Adverse Events due to prior anti-tumor therapy.\n* Presence of pleural\u002Fabdominal effusion requiring clinical intervention.\n* Known history of other primary malignancy.\n* Evidence of brain metastasis and\u002For cancerous meningitis\n* Inadequate bone marrow reserve or hepatic\u002Frenal functions.\n* Cardiological examination abnormality.\n* Severe, uncontrolled or active cardiovascular disorders.\n* Serious or poorly controlled diabetes.\n* Serious or poorly controlled hypertension.\n* Clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose of study treatment.\n* Serious infections within 4 weeks prior to the first dose.\n* Have received systemic glucocorticoid therapy for more than 7 days within 28 days prior to the first dose study treatment, or require chronic (≥ 7 days) use of systemic glucocorticoids during the study, or have other acquired, congenital immunodeficiency disorders, or a history of organ transplantation.\n* Presence of active infectious diseases such as hepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiency virus infection, etc.\n* Current hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Class B or more severe cirrhosis.\n* Any moderate or severe lung diseases that may interfere with the detection and treatment of drug-related pulmonary toxicity or may seriously affect respiratory function.\n* History of severe neurological or psychiatric disorder.\n* Pregnant or breast-feeding women or women who intend to become pregnant during the study.\n* Attenuated live vaccination within 4 weeks prior to the first dose.\n* Subjects with autoimmune disease that is active or is likely to recur.\n* Subjects with gastrointestinal fistula, visceral fistula, gastrointestinal perforation, or abdominal abscess, or with symptoms\u002Fsigns of intestinal obstruction within 6 months prior to the first dose of study drug.\n* Subjects unlikely to comply with study procedures, restrictions and requirement as determined by the investigator.\n* Subjects with any condition that jeopardizes the safety of the patient or interferes with the assessment of the study, as judged by the investigator.",{"count":359,"type":20},157,[23],"HS-10502 is a PARP1-specific selective inhibitor. The purpose if this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10502 Combination Treatment in subjects with advanced solid tumors.",[363,364,365,49,366,367],"Recurrent Ovarian Cancer","HER2-negative","Advanced Breast Cancer","Advanced Prostate Cancer","Advanced Gastric Cancer",[369,356,370,371,49,372,373],"Poly(ADP-ribose) polymerase-1 inhibitor","ovarian cancer","breast cancer","prostate cancer","gastric cancer","2025-06-18",{"date":376,"type":90},"2025-06-24",{"date":378,"type":90},"2025-05-07",{"date":380,"type":20},"2026-08-31",{"name":382,"class":97},"Jiangsu Hansoh Pharmaceutical Co., Ltd.",{"id":384,"slug":385,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":263,"minAge":105,"maxAge":390,"enrollmentInfo":391,"targetDuration":4,"studyType":21,"phases":393,"briefSummary":395,"conditions":396,"keywords":4,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":4},"100594577","phase-3-comparing-utd2-combined-with-capecitabine-to-capecitabine-as-adjuvant-therapy-for-non-pcr-tnbc-patients-100594577","NCT07021261","Comparing UTD2 Combined With Capecitabine to Capecitabine as Adjuvant Therapy for Non-pCR TNBC Patients","A Multicenter, Open-Label, Randomized, Phase III Study Comparing UTD2 Combined With Capecitabine to Capecitabine Monotherapy as Adjuvant Therapy for Triple-Negative Breast Cancer Patients Who Did Not Achieve Pathological Complete Response","Inclusion Criteria:\n\n1. Informed Consent and Compliance The patient has fully understood this study and voluntarily signed the informed consent form, demonstrating the ability and willingness to comply with the study protocol-defined visits, treatment plans, laboratory tests, and other study procedures.\n2. Age and Gender Female patients aged 18 to 70 years old (inclusive) on the day of signing the informed consent.\n3. Prior Neoadjuvant Chemotherapy without pCR Received prior neoadjuvant chemotherapy containing anthracycline or taxane agents without achieving pathological complete response (pCR).\n\n   Neoadjuvant chemotherapy requirement: At least 4 completed cycles. Non-pCR definition: Residual invasive carcinoma confirmed by pathology after primary tumor resection.\n4. Surgical Resection Underwent complete surgical resection (R0) with pathologically confirmed negative margins.\n5. Triple-Negative Breast Cancer Confirmation\n\n   Post-resection tumor tissue confirmed as ER-negative, PR-negative, and HER2-negative breast cancer by immunohistochemistry (IHC):\n\n   ER-negative: \\\u003C1% expression by IHC. PR-negative: \\\u003C1% expression by IHC. HER2-negative: IHC score of 0 or 1+, or 2+ with negative in situ hybridization (ISH) results.\n6. Postoperative Treatment No prior systemic anticancer therapy (excluding radiotherapy) after breast cancer surgery.\n7. Performance Status ECOG performance status of 0 to 1.\n8. Hematological Criteria (within 1 week prior to enrollment)\n\n   Blood tests meet the following criteria (CTCAE v5.0 ≤ Grade 1, based on institutional laboratory standards):\n\n   White blood cell (WBC) count ≥ 3.0 × 10\\^9\u002FL. Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL. Platelet (PLT) count ≥ 100 × 10\\^9\u002FL. Hemoglobin ≥ 9.0 g\u002FdL. No administration of recombinant human granulocyte colony-stimulating factor (rhG-CSF), blood products, or erythropoietin (EPO) within 14 days prior to enrollment.\n9. Biochemical Criteria (within 1 week prior to enrollment)\n\nNormal blood biochemistry (CTCAE v5.0 ≤ Grade 1, based on institutional laboratory standards):\n\nTotal bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN). Alanine aminotransferase (ALT) ≤ 1.5 × ULN. Aspartate aminotransferase (AST) ≤ 1.5 × ULN. Alkaline phosphatase (ALP) ≤ 2.5 × ULN. Creatinine clearance (Ccr) ≥ 50 mL\u002Fmin. Contraception Requirements Fertile patients must agree to use highly effective contraception (hormonal, barrier methods, or abstinence) with their partners during the trial and for at least 6 months after the last dose. Premenopausal female patients must have a negative blood or urine pregnancy test before enrollment.\n\nExclusion Criteria:\n\n1. Stage IV metastatic breast cancer.\n2. Bilateral breast cancer.\n3. History of other malignancies within the past 5 years, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, or papillary thyroid carcinoma.\n4. Radiotherapy within 2 weeks prior to the first dose of the study drug.\n5. Surgery within 2 weeks prior to the first dose of the study drug.\n6. Prior treatment with utidelone or capecitabine, known hypersensitivity to utidelone, capecitabine, or fluoropyrimidines, or confirmed dihydropyrimidine dehydrogenase (DPD) deficiency.\n7. Prior adverse reactions to anticancer therapy have not recovered to CTCAE v5.0 Grade ≤1 (excluding toxicities deemed non-risky by the investigator, such as alopecia).\n8. Gastrointestinal disorders (e.g., esophageal obstruction, pyloric obstruction, intestinal obstruction), post-gastrointestinal resection, or other factors causing dysphagia that may interfere with oral drug absorption.\n9. Severe comorbidities, including significant cardiac\u002Fcerebrovascular disease, uncontrolled diabetes\u002Fhypertension, active infections, or active peptic ulcer.\n10. Active hepatitis B virus (HBV) infection.\n11. History of immunodeficiency (e.g., HIV-positive status, congenital\u002Facquired immunodeficiency disorders) or organ transplantation.\n12. Psychiatric disorders or poor compliance.\n13. Pregnancy (positive pregnancy test) or lactation.\n14. Concurrent participation in another interventional clinical study or receiving other investigational therapies.\n15. Concomitant use of potent CYP3A4 inhibitors\u002Finducers or QT-prolonging drugs within 14 days prior to the first dose or during the study.\n16. Other conditions deemed unsuitable for study participation by the investigator.","70 Years",{"count":392,"type":20},440,[394],"PHASE3","Evaluate the IDFS rate, overall survival (OS) rate, and safety profile of UTD2 combined with capecitabine versus capecitabine monotherapy as adjuvant therapy for triple-negative early breast cancer patients who did not achieve pathological complete response (pCR) after neoadjuvant therapy.",[36,49],"2025-06-06",{"date":399,"type":90},"2025-06-13",{"date":401,"type":20},"2025-06-16",{"date":403,"type":20},"2032-06-16",{"name":210,"class":126},{"id":406,"slug":407,"hasResults":11,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":11,"sex":263,"minAge":105,"maxAge":165,"enrollmentInfo":412,"targetDuration":4,"studyType":414,"phases":4,"briefSummary":415,"conditions":416,"keywords":417,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":184},"100592312","sacituzumab-govitecan--toripalimab-as-first---line-therapy-for-advanced-triple---negative-breast-cancer-and-biomarker-exploration-100592312","NCT06991790","Sacituzumab Govitecan + Toripalimab as First - Line Therapy for Advanced Triple - Negative Breast Cancer and Biomarker Exploration","A Prospective, Single-arm, Multicenter Phase II Clinical Study of Sacituzumab Govitecan in Combination With Toripalimab as First-line Treatment for Advanced Triple-negative Breast Cancer and an Exploratory Study of Biomarkers for Predicting Efficacy","Inclusion Criteria:\n\n1. Female breast cancer patients aged 18 to 75 years old;\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score: 0 to 1;\n3. Patients with histologically or cytologically confirmed advanced triple-negative breast cancer;\n4. Patients who have not received systemic treatment (including chemotherapy, targeted therapy and immunotherapy) for advanced triple-negative breast cancer;\n5. According to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard, having at least one measurable lesion;\n6. Deciding to receive anti-tumor treatment with the combination of sacituzumab govitecan and toripalimab.\n\nExclusion Criteria:\n\n1. Patients with symptomatic brain metastases (such as increased intracranial pressure, epilepsy, etc.) who require emergency radiotherapy or surgical intervention;\n2. Patients who have previously received HER2-targeted therapy or Trop-2-targeted therapy;\n3. Patients who have previously used or are currently using PD-(L)1 inhibitors and\u002For ADC drugs containing topoisomerase inhibitors, such as sacituzumab govitecan, Dato-DXd, etc., as well as topoisomerase inhibitors;\n4. Patients who are considered by the investigator to be unsuitable for participating in this study.",{"count":413,"type":20},51,"OBSERVATIONAL","The goal of this study is to explore the efficacy and safety of sacituzumab govitecan in combination with toripalimab as first - line treatment in patients with advanced triple - negative breast cancer.\n\nThe main questions it aims to answer are:\n\n1. To investigate the efficacy and safety of sacituzumab govitecan in combination with toripalimab as first - line treatment for advanced triple - negative breast cancer.\n2. To explore the biomarkers that can predict the efficacy of sacituzumab govitecan in combination with toripalimab as first - line treatment for advanced triple - negative breast cancer.\n\nParticipants will:\n\nHave their progression - free survival (PFS) observed and evaluated. Have all adverse events and immune - related adverse events monitored to assess safety.\n\nHave their objective response rate measured as a secondary outcome. Have their survival period tracked as a secondary outcome. Have biomarkers associated with efficacy observed and explored as a secondary outcome.",[49],[418,419,420,421,422,423],"sacituzumab govetican","toripalimab","ADC","triple-negative breast cancer","first-line therapy","immune-checkpoint inhibitor","2025-05-18",{"date":426,"type":90},"2025-05-28",{"date":428,"type":90},"2025-05-01",{"date":430,"type":20},"2028-05-01",{"name":432,"class":126},"Peking University Cancer Hospital & Institute",{"id":434,"slug":435,"hasResults":11,"nctId":436,"briefTitle":437,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":21,"phases":441,"briefSummary":442,"conditions":443,"keywords":444,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":4},"100573483","phase-2-a-phase-ii-clinical-study-to-evaluate-the-safety-pharmacokinetic-profile-and-preliminary-efficacy-of-imm2510-in-combination-with-chemotherapy-as-first-line-treatment-in-subjects-with-non-small-cell-lung-cancer-or-triple-negative-breast-cancer-100573483","NCT06746870","A Phase II Clinical Study to Evaluate the Safety, Pharmacokinetic Profile, and Preliminary Efficacy of IMM2510 in Combination with Chemotherapy As First-line Treatment in Subjects with Non-small Cell Lung Cancer or Triple-negative Breast Cancer","Inclusion Criteria:\n\n1. Fully understand and voluntarily sign the ICF for this study ;\n2. Aged ≥ 18 years old;\n3. Cohort 1: NSCLC; EGFR wild-type and negative for ALK or ROS1 fusion genes. Cohort 1a: Non-squamous NSCLC (NSQ-NSCLC); Cohort 1b: Squamous NSCLC (SQ-NSCLC); Cohort 2: Breast cancer, negative for ER, PR, and HER-2. Definition of negative for ER and PR: IHC ER \\\u003C 1%, IHC PR \\\u003C 1%. Definition of negative for HER-2: IHC HER-2 (-) or (1+); for HER-2 (2+), FISH testing must be performed and the result must be negative;\n4. Cohort 1: Previous systemic treatment for advanced NSCLC has not been received. If neoadjuvant and\u002For adjuvant treatment was previously received, the time from the completion of neoadjuvant and\u002For adjuvant treatment to the occurrence of recurrence\u002Fmetastasis must be ≥ 12 months; Patients enrolled in the safety run-in period have previously failed at least first-line systemic treatment, are intolerant to, or not suitable for first-line systemic treatment for NSCLC; Cohort 2: Previous systemic treatment for advanced TNBC has not been received. If neoadjuvant and\u002For adjuvant treatment included taxane-based anti-tumor treatment, the time from the completion of taxane-based neoadjuvant and\u002For adjuvant treatment to the occurrence of recurrence\u002Fmetastasis must be ≥ 12 months; Patients enrolled in the safety run-in period have previously failed at least first-line systemic treatment, are intolerant to, or not suitable for first-line systemic treatment for TNBC;\n5. ECOG score of 0 or 1;\n6. Have measurable lesions (according to RECIST 1.1).\n7. Expected survival ≥ 12 weeks;\n8. Provide archival tumor tissue samples or newly obtained needle biopsy or surgical resection samples of tumor lesions (previously unirradiated) for central PD-L1 and other biomarker tests. Formalin-fixed, paraffin-embedded (FFPE) tissue blocks are preferred over slides. Newly obtained biopsy samples are preferred over archival samples. Formalin-fixed samples are preferred after the subject is diagnosed with metastatic disease. If a recent biopsy is not feasible, biopsy samples obtained prior to adjuvant\u002Fneoadjuvant chemotherapy are acceptable.\n9. Upon signing the ICF, females of childbearing potential and males must agree to practice effective contraception during the study and for 6 months after the last dose, and females of childbearing potential must have a negative result for pregnancy test within 3 days pre-dose;\n\nExclusion Criteria:\n\n1. Received approved or investigational anti-tumor treatments within 4 weeks prior to the start of study treatment\n2. Received nonspecific immunomodulatory treatments within 2 weeks prior to the start of study treatment;\n3. Previously received any antibody or inhibitor targeting PD-1\u002FPD-L1 or VEGF;\n4. Laboratory abnormalities\n5. History of pulmonary fibrosis or current presence of severe pulmonary functional impairment\n6. Uncontrolled chronic disease\n7. Unresolved toxicity\n8. Uncontrolled brain metastases\n9. Active infection\n10. Bleeding Risk",{"count":440,"type":20},148,[24],"This is a single-arm, multicenter, open-label Phase II clinical study evaluating the efficacy and safety of IMM2510 in combination with chemotherapy as first-line treatment in patients with stage IV metastatic or recurrent NSCLC or unresectable locally advanced or metastatic TNBC.\n\nThe target population includes: Cohort 1: Patients with histologically or cytologically confirmed stage IV metastatic or recurrent NSCLC who are EGFR wild-type and negative for ALK or ROS1 fusion genes, and who have not received prior systemic treatment for NSCLC; Cohort 2: Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic TNBC who are negative for estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor-2 (HER-2), and who have not received prior systemic treatment for TNBC; This study is divided into two phases. Phase I is the safety run-in period, which will preliminarily explore the safety and PK profile of IMM2510 in combination with chemotherapy in patients with NSCLC or TNBC who have previously failed at least first-line systemic treatment, are intolerant to, or not suitable for first-line systemic treatment, to determine the dose for the combination treatment. Phase II is the expanded enrollment period, which will enroll NSCLC patients (Cohort 1; where Cohort 1a is for NSQ-NSCLC and Cohort 1b is for SQ-NSCLC), or TNBC patients (Cohort 2), according to the dose for the combination treatment determined in Phase I, to further explore the preliminary clinical efficacy, safety, and PK profile of IMM2510 in combination with chemotherapy as first-line treatment in patients with NSCLC or TNBC.",[44,49],[44,49,445],"IMM2510","2024-12-18",{"date":448,"type":90},"2024-12-24",{"date":450,"type":20},"2024-12",{"date":452,"type":20},"2026-12",{"name":454,"class":126},"ImmuneOnco Biopharmaceuticals (Shanghai) Inc.",{"id":456,"slug":457,"hasResults":11,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":21,"phases":463,"briefSummary":464,"conditions":465,"keywords":4,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":184},"100532256","phase-2-shr-a1921-combined-with-bevacizumab-in-triple-negative-breast-cancer-with-brain-metastases-100532256","NCT06210438","SHR-A1921 Combined With Bevacizumab in Triple-negative Breast Cancer With Brain Metastases","SHR-A1921 Combined With Bevacizumab in Triple-negative Breast Cancer With Brain Metastases：a Prospective, Single-arm, Single-center Phase II Clinical Study","Inclusion Criteria:\n\n1. Age ≥ 18 years old, both genders\n2. ECOG Performance Status of 0-2\n3. Pathological tests confirm HR-negative\u002FHER2-negative breast cancer；there is evidence of local recurrence or metastasis；not suitable with curative surgery or radiation therapy；HR negative is defined as: ER-negative and PR-negative, the proportion of positively stained tumor cells in all tumor cells is \\<10%；HER2- negative is defined as: histologically confirmed to be HER2 IHC (0) or HER2 IHC(1+) or HER2 IHC (2+) and FISH(-)\n4. Must have life-expectancy of ≥ 3 months\n5. MRI confirmed brain metastases, at least one intracranial parenchymal metastatic lesion with a longest diameter ≥ 1.0 cm without prior radiotherapy；\n6. Intraventricular catheter shunting or mannitol、steroid hormone、anticonvulsant drug is allowed before enrollment, but the dose of drug should be stable for at least one week and the neurological symptoms are stable for ≥1 week\n7. Adequate function of major organs meets the following requirements (1)Blood routine\n\n   * ANC≥1.5×109\u002FL；\n   * PLT≥75×109\u002FL；\n   * Hb≥90 g\u002FL(Allows blood transfusion or the use of medication to ensure that the content of hemoglobin) (2)Coagulation\n   * INR≤1.5，APTT≤1.5×ULN (3)Blood biochemistry\n   * TBIL≤1.5 × ULN;\n   * ALT and AST≤3 × ULN (liver metastasis≤5.0 × ULN);\n   * Urea nitrogen ≤ 1.5 × ULN; Cr≤1.5 × ULN or creatinine clearance ≥50 mL \u002F min (Cockcroft-Gault formula) (4)Cardiac ultrasound\n   * LVEF≥50%; (5)12-lead ECG:\n   * females QTcF interval \\<470msec and males \\<450ms;\n8. Willing to join the study, sign informed consent, have good compliance and cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Leptomeningeal or cystic metastases confirmed by MRI or lumbar puncture\n2. Presence of third interstitial fluid that cannot be controlled by drainage or other methods (e.g., a large amount of pleural effusion and ascites);\n3. Whole brain radiotherapy, chemotherapy, biological targeted therapy, immunotherapy, surgery or endocrine therapy within 2 weeks prior to enrolment\n4. Has received prior therapy with bevacizumab and TROP-2 ADC drugs\n5. Participation in any other clinical trials within 2 weeks of enrollment\n6. Concurrent use of any other Anti-cancer drugs\n7. Other malignancies within 5 years, except cured in-situ of uterine cervix carcinoma , skin basal cell carcinoma and squamous-cell carcinoma\n8. History of heart disease: (1) Arrhythmias requiring medical treatment or clinical significance, (2) Myocardial infarction, (3) Heart failure, (4)Any heart diseases that investigator believes not suitable for this study\n9. History of allergy or hypersensitivity to any of the study drugs or study drug components\n10. History of immunodeficiency including HIV-positive, active hepatitis B\u002FC, other acquired, congenital immunodeficiency disease or history of organ transplantation\n11. A clear history of neurological or mental disorders, including epilepsy or dementia\n12. Pregnant or breastfeeding women. Women of childbearing potential who have a positive pregnancy test or unwilling to use adequate contraception prior to enrollment and for the duration of study participation\n13. According to the investigator\\'s judgment, there is a concomitant disease that seriously endangers the safety of subjects or affects the completion of the study (including but not limited to severe hypertension, severe diabetes, active infection, thyroid disease that cannot be controlled by drugs)\n14. Any condition which in the investigator\\'s opinion makes the subjects unsuitable for the study participation",{"count":193,"type":20},[24],"This is a phaseⅡ, single-arm study evaluating the efficacy and safety of SHR-A1921 Combined with Bevacizumab in Triple-negative Breast Cancer with Brain Metastases",[49,197],"2024-01-17",{"date":468,"type":90},"2024-01-18",{"date":470,"type":20},"2024-02-01",{"date":472,"type":20},"2026-06-30",{"name":210,"class":126}]