[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"triple-negative-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:triple-negative-breast-cancer":183},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,176,0,25,[9,41,86,112,143,171,200,221,250,273,296,370,393,416,455,504,530,558,584,615,639,660,688,708,733],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100546318","phase-3-sacituzumab-tirumotecan-mk-2870-plus-pembrolizumab-versus-tpc-in-tnbc-who-did-not-achieve-pcr-mk-2870-012-100546318",false,"NCT06393374","Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)","A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) at Surgery","Inclusion Criteria:\n\n* Has centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) guidelines\n* Has no evidence of locoregional or distant relapse, as assessed by the treating physician\n* Had neoadjuvant treatment based on the KEYNOTE-522 regimen (pembrolizumab with carboplatin\u002Ftaxanes and pembrolizumab with anthracycline-based chemotherapy) followed by surgery according to National Comprehensive Cancer Network (NCCN) treatment guidelines for TNBC\n* Had adequate excision and surgical removal of all clinically evident disease in the breast and\u002For lymph nodes and have adequately recovered from surgery\n* Has non-pathologic complete response at surgery\n* Is able to continue on adjuvant pembrolizumab\n* Randomization must be conducted within 16 weeks from surgical resection\n* Completed adjuvant radiation therapy (if indicated) and recovered before randomization\n* Has provided tissue from the surgical resection for central laboratory determination of trophoblast cell surface antigen 2 (TROP2) status\n* If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention (120 days for sacituzumab tirumotecan and 95 days for capecitabine \\[no restriction for pembrolizumab\\]): agrees to refrain from donating sperm AND is either abstinent and agrees to remain abstinent or uses highly effective contraception\n* For females (assigned at birth), is not pregnant or breastfeeding and ≥1 of the following applies: is not a participant of childbearing potential (POCBP) OR is a POCBP and uses highly effective contraception after the last dose of study intervention (210 days for sacituzumab tirumotecan, 120 days for pembrolizumab, and 185 days for capecitabine). Abstains from breastfeeding during the study intervention period and for at least 120 days after study intervention\n* Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline (except alopecia)\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\n* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before first dose of study treatment\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B birus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization\n\nExclusion Criteria:\n\n* Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) and is eligible for adjuvant therapy with olaparib where olaparib is approved and available\n* Has Grade \\>2 peripheral neuropathy\n* History of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \\>480 ms, and\u002For other serious cardiovascular and cerebrovascular diseases within 6 months prior to study intervention\n* Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) or a topoisomerase I inhibitor-containing ADC\n* Received anticancer therapy in the adjuvant phase including but not limited to chemotherapy, small molecule anticancer drugs, poly (adenosine diphosphate ribose) polymerase (PARP) inhibitors, ADCs, and\u002For immunotherapy, with the exception of adjuvant radiation therapy\n* Is currently receiving a strong inducer\u002Finhibitor of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study. The required washout period before starting sacituzumab tirumotecan is 2 weeks\n* Except for pembrolizumab as neoadjuvant therapy for early-stage TNBC: received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein-4 \\[CTLA-4\\], OX-40 \\[cluster of differentiation (CD) 134\\], or CD137)\n* Except for chemotherapy as neoadjuvant therapy for early-stage TNBC: Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization\n* Received prior radiotherapy within 3 weeks of start of study intervention or required corticosteroids for radiation related toxicities that cannot be discontinued before the first dose of study intervention\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n* Has known additional malignancy that is progressing or has required active treatment within the past 5 years\n* Has diagnosis of immunodeficiency or is 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 the first dose of study medication\n* Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed\n* Has history of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease\n* Has active infection requiring systemic therapy\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has concurrent active hepatitis B and hepatitis C virus infection\n* Has history of allogeneic tissue\u002Fsolid organ transplant","ALL","18 Years",{"count":20,"type":21},1530,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician's choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sacituzumab tirumotecan plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sacituzumab tirumotecan plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.",[27],"Triple-Negative Breast Cancer","RECRUITING","2026-08-20",{"date":31,"type":32},"2026-08-21","ACTUAL",{"date":34,"type":32},"2024-06-24",{"date":36,"type":21},"2037-12-14",{"name":38,"class":39},"Merck Sharp & Dohme LLC","INDUSTRY",308,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":67,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100639777","phase-1-a-first-in-human-study-of-hh160-in-patients-with-advanced-solid-tumors-100639777","NCT07623369","A First-in-Human Study of HH160 in Participants With Advanced or Metastatic Solid Tumors","An Open-Label, Multicenter, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Antitumor Activity of HH160 Alone or in Combination With Other Antitumor Agents in Patients With Advanced or Metastatic Solid Tumors","Key Inclusion Criteria\n\n1. Adults aged 18 to 75 years with signed informed consent.\n2. Histologically or cytologically confirmed advanced solid tumors meeting phase-specific disease requirements.\n3. At least 1 measurable lesion per RECIST v1.1.\n4. Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status of 0 or 1 with life expectancy ≥ 12 weeks.\n5. Adequate organ function based on protocol-specified laboratory criteria.\n\nKey Exclusion Criteria\n\n1. Active leptomeningeal disease or uncontrolled\u002Funtreated brain metastases.\n2. History of severe hypersensitivity reactions to monoclonal antibodies, bispecific antibodies, trispecific antibodies, or study drug components.\n3. Other malignancy within 3 years prior to first dose, except specified curatively treated cancers.\n4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage.\n5. Significant bleeding risk, severe coagulopathy, gastrointestinal hemorrhage, or recent pulmonary hemorrhage\u002Fhemoptysis.\n\nNOTE: Other eligibility criteria may apply.","75 Years",{"count":50,"type":21},299,[52],"PHASE1","This study is evaluating the safety, side effects, how the body processes HH160, and its early anticancer activity when given alone or with other cancer treatments in participants with advanced solid tumors. The study will also identify the recommended dose for future studies. The trial includes two phases and is expected to last about 4 years, with treatment and follow-up lasting approximately 6-12 months each.",[55,56,57,58,59,60,61,62,63,64,65,66],"Solid Tumor","Non-small Cell Lung Cancer","Hepatocellular Carcinoma","Colorectal Cancer","Head and Neck Squamous Cell Carcinoma","Renal Cell Carcinoma","Endometrial Cancer","Cervical Cancer","Small-cell Lung Cancer","Triple Negative Breast Cancer","Urothelial Carcinoma","Gastroesophageal Adenocarcinoma",[68,69,56,70,57,71,58,72,73,59,60,74,61,62,63,64,75,65,66,76],"HH160","PD-1×CTLA-4×VEGF-A Antibody","NSCLC","HCC","CRC","GEA","RCC","TNBC","Ovarian Cancer","2026-08-19",{"date":31,"type":32},{"date":80,"type":32},"2026-06-11",{"date":82,"type":21},"2028-08",{"name":84,"class":39},"Huahui Health",3,{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":90,"conditions":97,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":111},"100601788","phase-1-a-study-to-investigate-safety-of-azd6750-in-adult-participants-with-select-advanced-or-metastatic-solid-tumors-100601788","NCT07115043","A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors","A Phase I\u002FII Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select Advanced or Metastatic Solid Tumors","Inclusion criteria:\n\n* Participant ≥ 18 year\n* ECOG PS of 0 to 1\n* Provision of 'archival' tumor specimen\n* At least one measurable lesion according to RECIST v1.1,\n* Minimum life expectancy of 12 weeks\n* Adequate and stable cardiac function\n* Adequate bone marrow, liver and kidney function\n* Body weight ≥ 35 kg\n* Capable of giving signed informed consent\n\nModule 1 specific inclusion criteria:\n\n• Participants with locally advanced or metastatic select solid tumors (MM, Squamous cell carcinoma of skin, MCC, NSCLC, Head and neck squamous cell carcinoma, Gastric cancer\u002Fgastroesophaegeal junction cancer, RCC, HGSOC, Triple negative breast cancer) who have received adequate SoC\n\nModule 2 specific inclusion criteria:\n\n* Participants with Stage IV NSCLC Dose Escalation\u002FBackfills\n\n  1. Have received at least one prior regimen in metastatic setting (2L+ NSCLC). Participants with actionable tumor alterations should have received targeted therapy if locally available OR\n  2. Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.\n\n     Dose Expansion\n\n  \u003C!-- -->\n\n  1. Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.\n\n     Exclusion criteria:\n* Any evidence of:\n\nSevere or uncontrolled systemic diseases including respiratory, cardiac or tumor-related conditions\n\n* History or planned organ or allogeneic stem cell transplantation.\n* Active or prior documented autoimmune or inflammatory disorders, within the past 3 years\n* Any prior toxicities that led to permanent discontinuation of prior immunotherapy\n* Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anti-cancer therapy\n* Brain metastases unless treated, asymptomatic, stable, and not requiring continuous corticosteroids\n* Acute untreated or symptomatic malignant spinal cord compression, or a history of leptomeningeal carcinomatosis.\n* Active uncontrolled or chronic infection of hepatitis B, hepatitis C\n* Prior history of Grade ≥ 3 non-infectious pneumonitis.\n* Participant requires chronic immunosuppressive therapy (including steroids \\> 10 mg prednisone\u002Fday or equivalent).\n* Receipt of live attenuated vaccine within 30 days.\n\nModule 2 specific exclusion criteria:\n\n* Previous treatment with anti-TIGIT therapy\n* 1L NSCLC participants with genetic alteration such as EGFR that has a targeted therapy in 1L as per local SoC",{"count":94,"type":21},120,[52,96],"PHASE2",[98,56,99,60,100,64,59,101,102],"Melanoma","Squamous Cell Carcinoma (Skin)","Merkel Cell Carcinoma","Gastric Cancer\u002FGastroesophageal Junction Cancer","High Grade Serous Ovarian Carcinoma","2026-08-18",{"date":77,"type":32},{"date":106,"type":32},"2025-07-29",{"date":108,"type":21},"2029-10-02",{"name":110,"class":39},"AstraZeneca",13,{"id":113,"slug":114,"hasResults":12,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":127,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":142},"100577497","phase-1-first-in-human-study-of-atx-295-an-oral-inhibitor-of-kif18a-in-patients-with-advanced-or-metastatic-solid-tumors-including-ovarian-cancer-100577497","NCT06799065","First-in-Human Study of ATX-295, an Oral Inhibitor of KIF18A, in Patients With Advanced or Metastatic Solid Tumors, Including Ovarian Cancer","A Phase 1\u002F2, Open-Label, Dose-Escalation and Expansion First-In-Human Study of ATX-295, an Oral Inhibitor of the Kinesin Motor Protein KIF18A, in Patients With Locally Advanced or Metastatic Solid Tumors, Including High-Grade Serous Ovarian Cancer","Key Inclusion Criteria:\n\n* Patients with histologically confirmed solid tumors who have locally recurrent or metastatic disease, including HGSOC\n* Refractory to or relapsed after all standard therapies with proven clinical benefit, unless as deemed by the Investigator, the subject is not a candidate for standard treatment, there is no standard treatment, or the subject refuses standard treatment after expressing an understanding of all available therapies with proven clinical benefit\n* For the expansion cohorts, participants must have histological confirmation of HGSOC and be determined to be platinum-resistant, platinum-refractory, or platinum-intolerant\n* There is no limit to the number of prior treatment regimens\n* Have measurable or evaluable disease\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n\nKey Exclusion Criteria:\n\n* Clinically unstable central nervous system (CNS) tumors or brain metastasis\n* Any other concurrent anti-cancer treatment, except for hormonal blockade\n* Has undergone a major surgery within 3 weeks of starting study treatment\n* Medical issue that limits oral ingestion or impairment of gastrointestinal function that is expected to significantly reduce the absorption of ATX-295, however participants with a functioning distal ileostomy or colostomy may be permitted on trial\n* Clinically significant (ie, active) or uncontrolled cardiovascular disease\n* Need to use proton pump inhibitors on study or H2-receptor antagonists for the dose escalation portion of the study.\n* Unable to transition off strong or moderate CYP3A4 inhibitors or strong inducers\n* Pregnancy or intent to breastfeed or conceive a child within the projected duration of treatment\n\nOther inclusion and exclusion criteria as defined in the study protocol",{"count":120,"type":21},90,[52],"The goal of this study is to identify a safe and tolerated dose of the orally administered KIF18A inhibitor ATX-295. In addition, this study will evaluate the pharmacokinetics, pharmacodynamics and preliminary antitumor activity of ATX-295 in patients with advanced solid tumors and ovarian cancer.",[124,125,76,126,64],"Advanced Solid Tumors","Breast Cancer Recurrent","High-grade Serous Ovarian Carcinoma",[128,129,130,131,132,133],"KIF","KIF18A","HGSOC","Platinum-resistant","Platinum-intolerant","Platinum-refractory","2026-08-15",{"date":103,"type":32},{"date":137,"type":32},"2025-03-21",{"date":139,"type":21},"2027-08-30",{"name":141,"class":39},"Accent Therapeutics",9,{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":157,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":170},"100619226","phase-1-systemic-anti-cancer-therapy-dose-modifications-for-individuals-with-duffy-null-phenotype-100619226","NCT07341867","Systemic Anti-Cancer Therapy Dose Modifications for Individuals With Duffy Null Phenotype","A Pilot Study of Duffy Null-Specific Dose Modifications for Individuals With Duffy Null Phenotype Receiving Standard of Care Systemic Anti-Cancer Therapies","Inclusion Criteria:\n\n* Diagnosis of:\n\n  * Cohort 1: MM, based on IMWG criteria12, and currently requires treatment\n  * Cohort 2: Stage II or III TNBC, with definition per protocol Section 3.2.1 AND\n* Plan for treatment, per their treating physician, or currently receiving their first cycle (see 3.3.3 for definition) of:\n\n  * Cohort 1: Dara-RVd for MM\n  * Cohort 2: A Keynote 522-based regimen of carboplatin, paclitaxel, and pembrolizumab given as the first phase of neoadjuvant treatment for TNBC.\\*\\*\\*\n\n    * Participants are eligible even if the duration of carboplatin and paclitaxel goes beyond 4 cycles, or if the use of pembrolizumab, doxorubicin, and cyclophosphamide is not planned or is not certain, as long as neoadjuvant treatment starts with carboplatin-paclitaxel-pembrolizumab. This cohort will be referred to as \"Keynote 522\" for the remainder of the protocol.\n\nAND\n\n* Confirmed Duffy null phenotype\n\n  * Previous testing is acceptable if performed by a CLIA-approved test\n\nAND\n\n* Age \\>=18 years old\n\nExclusion Criteria:\n\n* Inability to understand and the willingness to sign a written informed consent document\n* ANC\\\u003C500 within 7 days of planned start of Cycle 1 Day 1.\n* Participants who have started treatment at the time of enrollment cannot have started Cycle 2 of therapy\n* Participants in Cohort 2 (TNBC) cannot have received any of the pembrolizumab, doxorubicin, and cyclophosphamide portion of therapy\n* Participants receiving any other investigational agents for any indication\n* Another known condition or medicine with known impacts on neutrophil counts or neutrophil function",{"count":120,"type":21},[52],"This study is comprised of a main study, an observational study, and optional survey studies. The main study is being done to see whether using Duffy null specific treatment dosing guidelines can reduce or delay dose modifications and avoid neutropenic fever (fever in the setting of low neutrophils) for people with Duffy null phenotype receiving treatment for multiple myeloma or triple negative breast cancer. The observational study is to collect dose modification and neutropenic fever information on patients who do not have the Duffy null phenotype and receive the same standard of care regimens to see if there are differences in dose modifications and neutropenic fever between the two groups. The survey studies seek to understand general health experiences and preferences and experiences specific to people with Duffy null phenotype.\n\nStudy Drugs Include:\n\n* Daratumumab\n* lenalidomide\n* bortezomib\n* dexamethasone\n* carboplatin\n* paclitaxel\n* pembrolizumab\n* cyclophosphamide\n* doxorubicin",[154,64,155,156],"Multiple Myeloma","Duffy Blood Group, Chemokine Receptor Gene Mutation","Duffy Blood Group, Chemokine Receptor Gene C.-67T>C",[158,154,64,159],"Duffy Null Phenotype","Dosing guidelines","2026-08-14",{"date":162,"type":32},"2026-08-17",{"date":164,"type":32},"2026-07-30",{"date":166,"type":21},"2029-03-31",{"name":168,"class":169},"Andrew Hantel, MD","OTHER",1,{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":181,"conditions":182,"keywords":185,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":199},"100543646","phase-2-intratumoral-int230-6-followed-by-neoadjuvant-immuno-chemotherapy-in-patients-with-early-tnbc-invincible-4-sakk-100543646","NCT06358573","Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early TNBC. INVINCIBLE-4-SAKK","Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early Triple-negative Breast Cancer (TNBC). An Open-label Randomized Two-cohort Phase 2 Clinical Trial. INVINCIBLE-4-SAKK","Inclusion Criteria:\n\n* Written informed consent according to country specific law and ICH GCP E6(R2) regulations before registration and prior to any trial specific procedures.\n* Newly histologically diagnosed, previously untreated locally advanced non-metastatic TNBC as defined by the most recent American Society of Clinical Oncology (ASCO) \u002F College of American Pathologist (CAP) guidelines .\n* The following stages according to staging per American Joint Committee on Cancer (AJCC) for breast cancer staging criteria version 8 are included: cT1c (1.5-2cm) N1-3 M0 or cT2-4c N0-3 M0.\n* Multifocal and multicentric primary tumors are allowed and the tumor with the most advanced T stage should be used to assess eligibility. If multifocal or multicentric disease TNBC needs to be confirmed for each focus.\n* Measurable disease in the breast with at least one lesion with a diameter ≥ 1.5cm that is evaluable per RECIST v1.1, visible in ultrasound and injectable.\n* Male or female subject Age ≥ 18 years.\n* ECOG performance status 0-1\n* Adequate bone marrow function (administration of G-CSF, EPO and\u002For blood transfusion within 14 days before registration is not allowed):\n\n  * neutrophil count ≥ 1.5 x 109\u002FL\n  * platelet count ≥ 100 x 109\u002FL\n  * hemoglobin ≥ 90 g\u002FL\n* Adequate hepatic function:\n\n  * total bilirubin ≤ 1.5 x ULN, or direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 x ULN\n  * AST and ALT ≤ 2.5 x ULN,\n  * Albumin 30 ≥ g\u002FL\n  * Lactate Dehydrogenase (LDH) \\\u003C2.5 ULN\n* Adequate renal function: estimated glomerular filtration rate (eGFR) ≥ 50 ml\u002Fmin\u002F1.73 m2 (according to CKD-EPI formula)\n* Adequate cardiac function: Left ventricular Ejection Fraction (LVEF) ≥ 50% as determined by echocardiography (ECHO)\n* Adequate coagulation function:\n\n  * INR ≤ 1.5 x ULN unless the patient is receiving anticoagulant therapy\n  * aPTT ≤ 1.5 x ULN unless the patient is receiving anticoagulant therapy\n  * If the patient is receiving anticoagulant therapy, the treating physician must determine that the anticoagulation can be stopped at least 24 hours prior to injection.\n* Women of childbearing potential must use highly effective contraception, are not pregnant or lactating and agree not to become pregnant during trial treatment and until 7 months after the last dose of INT230-6 or 6 months after standard of care treatment. A negative pregnancy test before inclusion into the trial is required for all women of childbearing potential. (www.swissmedicinfo.ch).\n* Men agree not to donate sperm or to father a child by using effective contraception during trial treatment and until 6 months after the last dose of INT230-6 or standard of care treatment (www.swissmedicinfo.ch).\n\nExclusion Criteria:\n\n* Inflammatory Breast Cancer cT4d\n* Unfavorable relation between tumor size and breast size as determined by judgement of the treating physician, surgeon and\u002For investigator, where tumor shrinkage during neoadjuvant immunochemotherapy is required for breast conserving surgery to be considered.\n* Unfavorable tumor location that can potentially result in an unfavorable cosmetic outcome (e.g. high upper inner quadrant) and\u002For close skin contact by judgment of the treating physician, surgeon and\u002For investigator.\n* The following histological subtypes of TNBC are excluded: Classic adenoid cystic carcinoma, secretory carcinoma, low-grade adenosquamous carcinoma, tall cell carcinoma with reversed polarity, high-grade metaplastic\n* History of invasive malignancy ≤3 years prior to signing informed consent (except treated basal cell or squamous cell skin cancer or in situ cervical cancer)\n* Prior chemotherapy, targeted therapy, radiation therapy or anti-PD-L1 agent for previous breast cancer or Ductal Carcinoma in Situ (DCIS) on the same side.\n* Concurrent bilateral breast cancer\n* Concomitant treatment with any other experimental drug for recent breast cancer diagnosis in another clinical trial.\n* Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA II or IV; unstable angina pectoris, history of myocardial infarction and acute coronary syndrome requiring stenting\u002Fbypass surgery within the last six months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia), significant QT-prolongation, uncontrolled hypertension.\n* Known history of human immunodeficiency virus (HIV) or active chronic hepatitis C or hepatitis B virus infection or any uncontrolled active systemic infection requiring intravenous (iv) antimicrobial treatment.\n* Active autoimmune disease that required systemic treatment in past 2 years (e.g., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroid hormone replacement, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.\n* History of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n* Known history of tuberculosis.\n* Known history of allogeneic organ or stem cell transplant.\n* Receipt of live attenuated vaccine (including yellow fever vaccine) within 30 days prior to registration.\n* Diagnosis of immunodeficiency, concomitant or prior use of immunosuppressive medication within 7 days before registration, with the exceptions of local (intranasal, topical and inhaled) corticosteroids, or systemic corticosteroids which must not exceed 10 mg\u002Fday of prednisone or a dose equivalent corticosteroid, and the premedication for chemotherapy.\n* Concomitant anticoagulation with warfarin or equivalent vitamin K antagonists (e.g. phenprocoumon), factor Xa inhibitors (e.g. rivaroxaban, apixaban), direct thrombin inhibitors (e.g. dabigatran) or platelet inhibitors\u002Fantiplatelet agents that cannot be stopped 24 hours before the administration of INT230-6. Aspirin (up to 300 mg\u002Fday) is allowed.\n* Any concomitant drugs contraindicated for use with the trial drug according to the Investigator Brochure (IB) and the immuno-chemotherapy treatment according to the approved product information.\n* Known hypersensitivity to trial drug or to any component of the trial drug or immuno-chemotherapy treatment.\n* Incapacitated adults and any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.",{"count":179,"type":21},61,[96],"About 10-20% of all individuals with breast cancer have a so-called triple-negative tumor (TNBC). This type of breast cancer has a particularly unfavorable course and a higher mortality rate compared to other forms of breast cancer. Research studies show that it is important for individuals with TNBC to achieve a so-called pathologic complete response (pCR) to treatment. In the phase II study SAKK 66\u002F22, it is being investigated whether the administration of the drug INT230-6 before surgery for breast cancer can increase the rate of pCR in the tumor and affected lymph nodes. The tolerability of INT230-6 as well as other factors such as response to treatment and the possibility of breast-conserving surgery are also being examined.",[183,184],"Triple-negative Breast Cancer","TNBC - Triple-Negative Breast Cancer",[186,75,187,188,189,190],"triple-negative breast cancer","Intratumoral INT230-6","neoadjuvant immuno-chemotherapy","INT230-6","early stage","2026-08-13",{"date":162,"type":32},{"date":194,"type":32},"2024-10-24",{"date":196,"type":21},"2031-12",{"name":198,"class":169},"Swiss Cancer Institute",10,{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":207,"minAge":18,"maxAge":48,"enrollmentInfo":208,"targetDuration":4,"studyType":22,"phases":210,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":170},"100428593","early-phase-1-monitoring-breast-cancer-immunotherapy-treatment-with-advanced-positron-emission-tomography-magnetic-resonance-imaging-petmri-100428593","NCT04861077","Monitoring Breast Cancer Immunotherapy Treatment With Advanced Positron Emission Tomography Magnetic Resonance Imaging (PET\u002FMRI)","Monitoring Breast Cancer Immunotherapy Treatment With Advanced PET\u002FMRI: A Pilot Study","Inclusion Criteria:\n\n1. Patients must be ≥ 18 years old and ≤ 75 years old\n2. Triple negative breast cancer (TNBC) patients (biopsy-proven) stage II-IV eligible\n3. \\>50%Programmed death-ligand 1 (PD-L1) positive\n4. Eligible for immunotherapy who are naïve to beginning any immunotherapy treatment\n5. May not be pregnant or breastfeeding\n6. Subjects must be willing to sign consent\n7. Adequate creatinine clearance per institutional guidelines and within 30 days\n8. Estimated life expectancy of greater than one year\n9. Patients must have one lesion with RECIST measurable disease (greater than 1 cm in diameter, measured from diagnostic breast MRI or staging CT)\n\nExclusion Criteria:\n\n1. Inability to provide informed consent\n2. Weight over 350 lbs., due to the scanner bore size\n3. Lactating, known or suspected pregnancy. Women with child-bearing potential must a have a negative serum Human chorionic gonadotropin (β-hCG) pregnancy test within 48 hours or a negative urine β-hCG pregnancy test within 24 hours of each PET imaging study.\n4. Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)\n5. Unable to lie still on the imaging table for one (1) hour\n6. contraindication for gadolinium-based contrast agent, ProHance (gadoteridol)\n7. Have received immunotherapy in the neoadjuvant or adjuvant setting","FEMALE",{"count":209,"type":21},20,[211],"EARLY_PHASE1","This clinical study will investigate the utility of Fludeoxyglucose (18F) fluoromisonidazole (FMISO), in patients diagnosed with triple negative breast cancer (stage II-IV disease), to monitor and predict the effect of immunotherapy. This is a parallel imaging study to current treatment strategies and no clinical decisions or outcomes will be based on the imaging. If promising, this data will be used to design larger trials. A total of 20 patients will be recruited for this study. This trial will not designate the participant's treatment plan; they will be eligible based on their treatment plan designated from their oncologist.",[64],{"date":162,"type":32},{"date":216,"type":21},"2027-06",{"date":218,"type":21},"2030-08",{"name":220,"class":169},"University of Alabama at Birmingham",{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":17,"minAge":228,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":22,"phases":231,"briefSummary":232,"conditions":233,"keywords":236,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":249},"100651921","phase-2-a-study-of-cyclophosphamide-methotrexate-fluorouracil-cmf-for-people-with-breast-cancer-100651921","NCT07768436","A Study of Cyclophosphamide, Methotrexate, Fluorouracil (CMF) for People With Breast Cancer","STUDY OF DOSE DENSE CMF (Cyclophosphamide, Methotrexate, Fluorouracil) as an Alternative to AC (Doxorubicin, Cyclophosphamide) in 2 Regimens in EARLY STAGE BREAST CANCER for Patients Greater or Equal to 70","Inclusion Criteria:\n\n* Patients must have histologically confirmed adenocarcinoma of the breast confirmed at MSK. The patient must have had diagnostic biopsy or completion of primary surgical management, within 3 months of enrollment. Results of HER-2\u002Fneu, estrogen receptor, and progesterone receptor are required for study entry.\n* Patients must be ≥ 70 years of age.\n* Patients must have ECOG performance status \\>2 (Karnofsky score of ≥ 60%).\n* Patients may have received hormonal therapy for the purpose of chemoprevention.\n* Adjuvant\u002Fneoadjuvant chemotherapy decision to treat based on the discretion of investigator\n* Cohort 1 only: Patients have any histology except Her 2 Neu positive in the adjuvant or neoadjuvant setting\n* Cohort 2 only: Patients have triple negative (ER- (10%) PR-Her 2 Neu -) in the neoadjuvant setting\n* Cohort 2 only: Patients have received at least 1 dose of carboplatin\u002Fpaclitaxel +\u002F- pembrolizumab in the neoadjuvant setting\n\nRequired Organ Function\n\nAdequate hematologic function defined as follows:\n\n* Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3\n* Platelets ≥ 100,000 cells\u002Fmm3\n\nAdequate renal function defined as follows:\n\n° Creatinine clearance (CrCL) of \\>30 mL\u002Fmin by the Cockcroft-Gault formula:\n\nCrCl (mL\u002Fmin) = \\[(\\[140 - age(years)\\] x weight (kg))\u002F72 x creatinine (mg\u002FdL)\\] (x 0.85 for female patients)\n\nAdequate hepatic function defined as follows:\n\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)\n* AST and ALT ≤3 x institutional ULN\n\n  * Patients or their Legally Authorized Representative must give written, informed consent indicating their understanding and willingness to participate in the study.\n\nExclusion Criteria:\n\n* Stage IV breast cancer\n* CARG score- high Frail 4 or more as assessed by CAIT\n* Her 2 Neu positive 3+\u002Famplified breast cancer\n* No prior chemotherapy within 1 year of study enrollment\n* Cohort 2 only: patients may not receive pembrolizumab during dd CMF treatment","70 Years",{"count":230,"type":21},76,[96],"The purpose of this study is to find out if it is practical (feasible) to give dose-dense CMF (cyclophosphamide, methotrexate, and fluorouracil) in two standard chemotherapy regimens in people with breast cancer, age 70 and older.",[234,235,64],"Adenocarcinoma of the Breast","Breast Cancer",[237,238,239,240,241],"adenocarcinoma of the breast","breast cancer","triple negative breast cancer","Memorial Sloan Kettering Cancer Center","26-303","2026-08-12",{"date":162,"type":32},{"date":245,"type":32},"2026-08-11",{"date":247,"type":21},"2030-08-11",{"name":240,"class":169},7,{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":17,"minAge":257,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":22,"phases":260,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":266,"completionDateStruct":267,"leadSponsor":269,"locationsCount":272},"100615827","phase-1-gcar1-a-chimeric-antigen-receptor-car-t-cell-therapy-for-relapsedrefractory-gpnmb-expressing-solid-tumours-100615827","NCT07297667","GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Relapsed\u002FRefractory GPNMB-Expressing Solid Tumours","A Phase I Study of GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Participants With Selected Relapsed\u002FRefractory GPNMB-Expressing Solid Tumours","Inclusion Criteria:\n\n* Archival tumour specimen must be positive for GPNMB with high expression by immunohistochemistry (central laboratory testing).\n* Histologically and\u002For cytologically confirmed diagnosis of one of the following tumours that is advanced\u002F metastatic\u002F recurrent or unresectable, for which no curative therapy exists.\n* alveolar soft part sarcoma\n* renal cell carcinoma (excluding clear cell)\n* triple negative breast cancer (ER, PR and HER-2 negative as defined by ASCO\u002FCAP criteria)\n* Must have a formalin fixed paraffin embedded tissue block (from primary or metastatic tumour) available and must have provided informed consent for the release of the block.\n* Presence of radiologically documented disease.\n* Measurable disease as defined by RECIST 1.1.\n* ASPS participants ≥ 15 years of age.\n* TNBC and RCC participants ≥ 18 years of age.\n* ECOG performance status of 0 or 1 or Karnofsky or Lansky \\> 60.\n* Anticipated life expectancy of ≥ 6 months.\n* Must have received prior systemic therapy as shown below;\n* ASPS - completed all systemic therapy available that has been shown to improve survival (unless contraindicated).\n* TNBC\n\n  1. Progressive disease following at least one line of systemic treatment for metastatic disease which must include an ADC (all participants) and an ICI (participants whose tumours express PD-L1).\n  2. ≤3 lines of treatment for metastatic disease.\n  3. Must have had at least 1 prior line of cytotoxic chemotherapy for breast cancer, in any setting, which must have included an anthracycline and a taxane (unless contraindicated).\n* RCC - must have progressive disease following at least one line of systemic treatment for metastatic disease that must have included an ICI and a VEGFR targeted agent (unless contraindicated).\n* Participants must have recovered to ≤ grade 1 from all reversible toxicity related to prior therapies.\n* Adequate washout must be followed per protocol.\n* Previous major surgery is permitted ≥21 days prior to enrollment\n* Prior external beam radiation is permitted ≥28 prior to enrollment. Concurrent radiotherapy is not permitted.\n* Adequate hematologic and biochemical parameters.\n* Consent and assent, when applicable, must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant or their parent\u002F legal guardian (if applicable) must sign a consent form prior to screening onto the trial to document their willingness to participate.\n* Fit for leukapheresis and has adequate venous access for cell collection.\n* Must be accessible for treatment and follow up at the participating centre for a minimum of 12 months or for as long as is deemed necessary by the treating physician.\n* Participants of childbearing potential must have agreed to use a highly effective contraceptive method.\n\nExclusion criteria\n\n* Participants on active anticancer therapy for other advanced or metastatic malignancies.\n* Concurrent treatment with other anti-cancer therapy\n* Prior therapy with a gene therapy product or any adoptive T cell therapy or prior GPNMB targeting therapy.\n* Live attenuated vaccination administered within 30 days prior to or planned within 30 days after GCAR1 therapy.\n* Primary immunodeficiency or history of severe autoimmune disease (including: Crohn's disease, rheumatoid arthritis, systemic lupus) requiring immunosuppressive agents\u002F systemic disease modifying agents within 2 years of enrollment.\n* Active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the participant to be managed according to the protocol including but not limited to:\n* Hepatitis B or C virus (HBV or HCV). For participants with previous HBV or HCV infection who are currently on treatment, they are eligible if they have an undetectable viral load via quantitative PCR and\u002For nucleic acid testing\n* HIV positive by serology and PCR\n* Uncontrolled fungal, bacterial, viral or other infection\n* Current infection with HTLV-1\n* Tuberculosis\n* Syphilis\n* West Nile Virus\n* Untreated and\u002For uncontrolled cardiovascular conditions and\u002For symptomatic cardiac dysfunction (including cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects) or unstable angina congestive heart failure or myocardial infarction within the previous year.\n* Known sensitivity or allergy to fludarabine, cyclophosphamide or any of their components, or to GCAR1 or any of its components.\n* Active intracerebral metastases or leptomeningeal disease. Participants who have received definitive treatment, are clinically stable and do not require corticosteroids are eligible to participate in the trial.\n* Pregnant or breastfeeding women.","15 Years",{"count":259,"type":21},30,[52],"Only enrolling in Canada.\n\nThe purpose of this study is to identify the highest dose of GCAR1, a chimeric antigen receptor (CAR-T) cell therapy, that can be tolerated without causing very severe side effects, and to see what effects GCAR1 has on selected cancers",[263,60,64],"Alveolar Soft Part Sarcoma","2026-08-10",{"date":242,"type":32},{"date":164,"type":32},{"date":268,"type":21},"2033-09-01",{"name":270,"class":271},"Canadian Cancer Trials Group","NETWORK",2,{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":22,"phases":282,"briefSummary":283,"conditions":284,"keywords":285,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":289,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":170},"100421487","phase-2-serial-circulating-tumor-dna-ctdna-monitoring-during-adjuvant-capecitabine-in-early-triple-negative-breast-cancer-100421487","NCT04768426","Serial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer","Phase II Trial of Circulating Tumor DNA Monitoring During Adjuvant Capecitabine in Patients With Triple-negative Breast Cancer and Residual Disease Following Standard Neoadjuvant Chemotherapy","Inclusion Criteria:\n\n1. Anatomic stage I - III triple-negative breast cancer at diagnosis\n2. Estrogen receptors (ER) and Progesterone receptors (PR) status \\\u003C10%\n3. Residual disease following at least 4 cycles of neoadjuvant chemotherapy. Patients who received other investigational immunotherapy or targeted therapy during the neoadjuvant phase of treatment are eligible.\n4. ≥ 18 years of age\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n6. All clinically significant toxic effects of prior cancer therapy resolved to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE, v 5.0), except alopecia and G2 neuropathy.\n7. No evidence of metastatic disease.\n8. A minimum 4-week wash out from previous chemotherapy treatment is required.\n9. Adequate hematologic function: Absolute neutrophil count (ANC) ≥ 1,500 cells\u002FμL (≥ 1,500\u002Fmm3); Platelets ≥ 100,000 cells\u002FμL (≥ 100,000\u002Fmm3)\n10. Adequate hepatic function: Bilirubin ≤ 1.5 times the specific institutional upper limit of normal (ULN). Exception: If Gilbert's syndrome; then ≤ 5 times ULN. Aspartate transaminase (AST) and alanine transaminase (ALT) each ≤ 2.5 x ULN\n11. Adequate renal function: Serum creatinine ≤ 1.5 x ULN; or calculated creatinine clearance \\> 50 mL\u002Fmin using the Cockcroft Gault formula.\n12. Planned for 6 months or 8 cycles of adjuvant capecitabine.\n13. Women of childbearing potential (WOCBP) must have a negative pregnancy test.\n14. WOCBP must agree to use effective contraception during the study and for 3 months after the last dose.\n15. Male participants and their female partners of child bearing potential must be willing to use an appropriate method of contraception during the study and for 3 months after the last dose.\n16. Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in the informed consent form (ICF) and in the protocol\n\nExclusion Criteria:\n\n1. Metastatic breast cancer\n2. Has not had definitive surgical resection\n3. Pregnant or breastfeeding\n4. Has not completed definitive adjuvant radiation if planned\n5. Known human immunodeficiency virus (HIV) positivity or active hepatitis B or C.\n6. Investigational agents within 4 weeks of study initiation\n7. Inability to swallow oral medications",{"count":281,"type":21},40,[96],"The purpose of the study is to evaluate the use of a circulating tumor DNA (ctDNA) assay, ie, a \"liquid biopsy,\" as a tool to identify triple-negative breast cancer (TNBC) patients who will or will not experience benefit from treatment with capecitabine. Participants will be monitored for changes in ctDNA in the blood over time received during capecitabine treatment. Results of ctDNA analysis will be correlated to genetic characteristics of individual tumors. This may inform future clinical trials in which patients could receive a different treatment than capecitabine to reduce their risk of breast cancer relapse.",[64,235],[75,64,286,287,288],"Post neoadjuvant","Residual disease","Capecitabine",{"date":242,"type":32},{"date":291,"type":32},"2021-02-03",{"date":293,"type":21},"2031-07",{"name":295,"class":169},"Stanford University",{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":12,"sex":17,"minAge":303,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":22,"phases":306,"briefSummary":307,"conditions":308,"keywords":332,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":369},"100407463","the-evaluation-of-pc14586-in-patients-with-advanced-solid-tumors-harboring-a-tp53-y220c-mutation-pynnacle-100407463","NCT04585750","The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","A Phase 1\u002F2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","Inclusion Criteria:\n\n* At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.\n* Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Previously treated with one or more lines of anticancer therapy and progressive disease\n* Adequate organ function\n* Measurable disease per RECIST v1.1 (Phase 2)\n\nAdditional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Anti-PD-1\u002FPD-L1 naive or must have progressed on treatment\n* Measurable disease\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug\n* Radiotherapy within 14 days of receiving the study drug\n* Primary CNS tumor\n* History of leptomeningeal disease or spinal cord compression\n* Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms\n* Stroke or transient ischemic attack within 6 months prior to screening\n* Heart conditions such as unstable angina within 6 months prior to screening, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities\n* Strong CYP3A4 inducers and strong CYP2C9 inhibitors\u002Finducers within 14 days of first dose of rezatapopt\n* History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication\n* History of prior organ transplant\n* Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n* Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection\n\nAdditional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy)\n\n* Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2)\n\nAdditional Criteria for Exclusion from Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)\n* Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention\n* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug\n* Hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* History of radiation pneumonitis\n* History of (non-infectious) or active pneumonitis \u002F interstitial lung disease that required steroids\n* Active infection requiring systemic therapy\n* Known history of HIV infection\n* Has previously received rezatapopt","12 Years",{"count":305,"type":21},300,[52,96],"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.",[309,310,311,312,313,76,61,314,58,235,315,316,317,318,319,320,321,70,322,323,324,64,75,325,326,327,328,329,330,331],"Advanced Solid Tumor","Advanced Malignant Neoplasm","Metastatic Cancer","Metastatic Solid Tumor","Lung Cancer","Prostate 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 (Non-small Cell Lung Cancer)","SCLC","Non-Small Cell Lung Carcinoma","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",[333,334,335,336,337,338,339,340,341,342,343,344,345,346,347,348,349,350,351,352,353,354,355,356,357,358,359,360],"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","2026-08-07",{"date":264,"type":32},{"date":364,"type":32},"2020-10-29",{"date":366,"type":21},"2027-12-31",{"name":368,"class":39},"PMV Pharmaceuticals, Inc",77,{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":207,"minAge":18,"maxAge":377,"enrollmentInfo":378,"targetDuration":4,"studyType":22,"phases":379,"briefSummary":380,"conditions":381,"keywords":382,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":170},"100561122","early-phase-1-breast-cancer-psma-pet-100561122","NCT06586047","Breast Cancer PSMA PET","Evaluation of PSMA Expression in Triple Negative Breast Cancer Patients Using 18 F-DCFPyL-PET\u002FCT","Inclusion Criteria:\n\n* Female \\>= 18 years of age\n* Patients in distantly metastatic TNBC based on the initial diagnosis biopsy.\n* Patient should have FDG positive metastatic lesions on the initial PET\u002FCT scan performed in this study to be further included.\n\nExclusion Criteria:\n\n* Patients with known active other malignancy.\n* Unable to tolerate PET\u002FCT procedure.\n* Pregnant or breastfeeding.\n* Patients with any medical condition that might compromise the safety of subject during PET acquisitions.","90 Years",{"count":259,"type":21},[211],"The purpose of this research is to determine the expression of Prostate Specific Membrane Antigen(PSMA) in metastatic Triple Negative Breast Cancer (TNBC) patients using Fludeoxyglucose F18 (FDG) PET\u002FCT as the gold standard. The investigators hypothesize that most lesions in metastatic TNBC are PSMA-avid; and thus PSMA-based radionuclide therapy can be a valid treatment option for TNBC, and clinical trials can be designed for this purpose. Thirty metastatic TNBC patients will be enrolled and will be on the study for maximum of 4 weeks.",[64],[383],"Breast cancer, PSMA expression, PET imaging","2026-08-05",{"date":386,"type":32},"2026-08-06",{"date":388,"type":32},"2024-08-29",{"date":390,"type":21},"2027-09-01",{"name":392,"class":169},"Ahmad Shariftabrizi",{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":401,"targetDuration":4,"studyType":22,"phases":403,"briefSummary":404,"conditions":405,"keywords":4,"overallStatus":406,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":415},"100606682","phase-3-neoadjuvant-therapy-comparing-sacituzumab-govitecanpembrolizumab-vs-soc-chemotherapy-in-clinical-stage-ii-iii-triple-negative-early-breast-cancer-100606682","NCT07178730","NeoAdjuvant Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer","NeoAdjuvant Dynamic Marker - Adjusted Personalized Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer","ADAPT-TN-IV","Inclusion Criteria:\n\nMinimal eligibility criteria to be met for registration in the clinical trial:\n\n1. TNBC: ER = 0%, PR = 0%, and HER2- (i.e., immunohistochemistry \\[IHC\\] with DAKO score ≤ 1 or fluorescence in situ hybridization \\[FISH\\]-negative)\n2. or TNBC-like: ER ≤ 10% positive cells in IHC, PR \\\u003C 10% positive cells in IHC, and HER2- (i.e., IHC with DAKO score ≤ 1 or FISH negative)\n3. All patients, independent from gender\n4. ≥18 years at diagnosis\n5. Histologically confirmed unilateral, primary invasive carcinoma of the breast Note: bilateral, multicentric, or multifocal carcinoma may be included, if there is a clear target (primary) lesion, that is subject to treatment decisions and solely evaluated and documented for study purposes. Histological confirmation of all lesions as TNBC is mandatory.\n6. Clinical stage II-III at baseline\n7. No clinical evidence for distant metastasis (M0)\n8. Cognitive and language skills to complete quality of life (QoL) questionnaires\n\n   Additional eligibility criteria to be met for assignment to cohort I or II:\n9. Completed 9-12 weeks of NACT with CARBO + PEM or PAC q1w + PEM q3w with the last dose of NACT given less than 2 weeks ago. Patients may also be considered if their NACT treatment was switched to nab-PAC due to intolerance to PAC.\n\n   * Patients with progressive disease during taxane-CARBO treatment are allowed to participate in cohort II after consultation with sponsor, provided that at least 6-9 weeks of NACT with taxane-CARBO q1w and PEM q3w have been administered\n   * Patients experiencing toxicities due to PEM, in case of contraindications or other medical reasons against PEM administration (with or without permanent discontinuation of PEM) can nevertheless be included, even if PEM will not be administered anymore. The number of patients starting the study without PEM is limited to 10%.\n10. Tumour block available for central pathology review\n11. Performance Status ECOG ≤ 1 or Karnofsky Index ≥ 80%\n12. Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements\n13. The patient must be capable of giving informed consent and be willing and able to comply with the requirements and restrictions in this protocol and accessible for treatment and follow-up\n14. Laboratory requirements (female and male patients, ≤ 14 days old)\n\n    * Neutrophils \\> 1.5 109\u002FL,\n    * Platelets \\> 100 109\u002FL,\n    * Total bilirubin \\\u003C 1 x upper level of normal (ULN),\n    * ASAT (sGOT) \\\u003C 2.5 x ULN,\n    * ALAT (sGPT) \\\u003C 2.5 x ULN,\n    * Creatinine ≤1.5 × ULN OR clearance ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN\n15. Clinical assessments:\n\n    \\- Normal Electrocardiogram (ECG) (within 42 days prior to induction treatment)\n16. Negative pregnancy test (urine or serum) within ≤ 14 days prior to registration in premenopausal patients and immediate implementation of adequate contraceptive measures.\n\n    Note: Pregnancy testing is to be repeated according to Schedule of Activities.\n17. The following age-specific requirements apply:\n\n    * Women aged \\\u003C50 years will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the site.\n    * Women aged ≥ 50 years will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments.\n18. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for women of child-bearing potential and need to discontinue HRT to allow confirmation of post-menopausal status prior to randomization\u002Fstudy enrolment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can participate without use of a contraceptive method.\n19. Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception, presented in Table 1 (see Section 4.4.2), from the time of enrolment and must agree to continue using such precautions for 7 months after the last dose of IMP. Not all methods of contraception are highly effective. Female patients must refrain from breastfeeding while on study and for 7 months after the last dose of IMP. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic, or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable.\n20. Female patients must not donate, or retrieve for their own use, ova from the time of randomization and throughout the study treatment period, and for at least 7 months after the final study drug administration. They should refrain from breastfeeding throughout this time. Preservation of ova may be considered prior to enrolment in this study.\n21. A male participant must agree to use a contraception as detailed in Appendix C of this protocol during the treatment period and for at least 7 months after the last dose of study treatment and refrain from donating sperm during this period.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to the compounds or incorporated substances of the IMPs\n2. Prior malignancy with a disease-free survival of \\\u003C 5 years, except curatively treated basalioma of the skin or pTis of the cervix uteri\n3. Any history of invasive breast cancer\n4. Previous or concurrent treatment with cytotoxic agents for any non-oncological reason unless clarified with sponsor\n5. Concurrent treatment with other experimental drugs\n6. Participation in another interventional clinical trial with or without any investigational, not marketed drug within 30 days or 5 half-lives of the respective drug, whichever is longer, prior to study entry. In case of other interventional trial contact Sponsor.\n7. Concurrent pregnancy: patients of childbearing potential or potentially childbearing partners of male patients must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment\n8. Breast feeding woman\n9. Reasons indicating risk of poor compliance\n10. Patients not able to consent\n11. Known polyneuropathy ≥ grade 2\n12. Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study including recovery from major surgery, autoimmune disease, known psychiatric\u002Fsubstance abuse disorders, acute cystitis, ischuria, and chronic kidney disease\n13. Uncontrolled infection requiring i.v. antibiotics, antivirals, or antifungals\n14. History of pneumonitis haemolytic anaemia, myocarditis, sclerosing cholangitis and exocrine pancreatic insufficiency, medical history of allogenic stem cell transplants, or solid organ transplant\n15. Active primary immunodeficiency, known human immunodeficiency virus (HIV) infection. Patients should be tested for HIV prior to randomization if required by local regulations or ethics committee. Patients who test positive for HIV-antibody are excluded.\n16. Active hepatitis B virus (HBV) or hepatitis C virus (HCV). In patients with a history of HBV or HCV, patients with the following detectable viral loads will be excluded.\n17. Patients who test positive for hepatitis B surface antigen (HBsAg). Patients who test positive for hepatitis B core antibody (anti-HBc) will require HBV DNA by quantitative polymerase chain reaction (PCR) for confirmation of active disease.\n18. Patients who test positive for HCV antibody will require HCV RNA by quantitative PCR for confirmation of active disease. Patients with a known history of HCV or a positive HCV antibody test will not require an HCV antibody test at enrolment and will only require HCV RNA by quantitative PCR for confirmation of active disease.\n19. Patients who received live vaccines within 30 days prior to randomization.\n20. Patients who are submitted to an institution by virtue of an order of a court or a governmental authority must be excluded from participation.",{"count":402,"type":21},765,[24],"TNBC is a heterogeneous disease with distinct pathological, genetic, and clinical features among subtypes. Treatment results for high-risk primary TNBC remain poor compared to other breast cancer subtypes. Preoperative chemotherapy is the standard of care for patients with stage II or III primary TNBC. Multiple lines of clinical evidence demonstrate that TNBC patients who achieve a pCR to NACT, (ypT0\u002Fis ypN0), have an excellent long-term prognosis. A meta-analysis of individual patient data confirmed a strong association of pCR after NACT with improved long-term event-free survival (EFS, hazard ratio \\[HR\\] 0.24) and overall survival (OS, HR 0.16) benefit. Taxane- and anthracycline-based neoadjuvant regimens generally result in pCR rates between 25-50% \\[REFs\\], whereas the addition of platinum increases pCR rates to approximately 50-55%.\n\nThe KEYNOTE-522 trial has demonstrated that the addition of the immune-checkpoint inhibitor PEM to anthracycline- (AC), taxane- and platinum-based NACT resulted in a significant increase in pCR rates to nearly 65%, associated with a significant reduction of recurrences (EFS, HR 0.65 at 5 years) and improvement of OS (HR 0.66). Based on these results, the KEYNOTE-522 regimen has been approved by the FDA and EMA and has become the standard of care for patients with stage II or III TNBC.\n\nDespite this significant progress, two major questions remain unresolved which will be investigated in the ADAPT-TN-IV trial:\n\n1. Do all patients require the full 6 months of NACT as per KEYNOTE-522 or is there a subgroup of patients who are sufficiently treated with 12 weeks of NACT plus PEM?\n2. Can incorporation of ADCs into the KEYNOTE-522 regimen improve response and outcomes in patients without an optimal early response? The outcome of patients with residual disease after 24 weeks of NACT and PEM remains suboptimal and there is an urgent need for more effective strategies. ADCs such as SG have demonstrated superior efficacy compared to standard chemotherapy in metastatic TNBC, resulting in substantially higher response rates and improved progression-free (PFS) and OS. Combination studies of ADCs and immunotherapy in metastatic TNBC have demonstrated significant activity, suggesting possible synergistic activity It is therefore a logical next step to investigate, whether the incorporation of SG in the NACT regimen can improve pCR rates and EFS results in patients who have residual clinical disease after 12 weeks of NACT with CARBO\u002FPAC + PEM.",[235,183],"NOT_YET_RECRUITING","2026-08-04",{"date":384,"type":32},{"date":410,"type":21},"2026-08-30",{"date":412,"type":21},"2033-03-31",{"name":414,"class":169},"Women's Cancer Study Group GmbH",26,{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":422,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":22,"phases":426,"briefSummary":427,"conditions":428,"keywords":435,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":447,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":454},"100551821","phase-1-a-study-of-ly4052031-in-participants-with-advanced-or-metastatic-urothelial-cancer-or-other-solid-tumors-100551821","NCT06465069","A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors","A Phase 1a\u002F1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors","NEXUS-01","Inclusion Criteria:\n\n* Have one of the following solid tumor cancers:\n\n  * Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinoma or prostate cancer\n  * Cohort A2\u002FB1\u002FB2: urothelial carcinoma\n  * Cohort C: triple negative breast cancer, non-small cell lung cancer, ovarian cancer, cervical cancer, HNSCC (head and neck squamous cell carcinoma), esophageal cancer, pancreatic cancer, or prostate cancer\n* Prior Systemic Therapy Criteria:\n\n  * Cohort A1\u002FC: Individual has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating investigator; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies\n  * Cohort A2\u002FB1\u002FB2: Individual must have received at least one prior regimen in the advanced or metastatic setting. There is no restriction on number of prior therapies.\n* Prior enfortumab vedotin specific requirements:\n\n  * Cohorts A1\u002FA2\u002FC: prior treatment with enfortumab vedotin is allowed, but not required\n  * Cohort B1: individual must be enfortumab vedotin naive in the advanced\u002Fmetastatic setting\n  * Cohort B2: individual must have received enfortumab vedotin in the metastatic\u002Fadvanced setting.\n* Measurability of disease\n\n  * Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)\n  * Measurable disease is required as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for all Cohorts. Cohort A1 may permit non-measurable disease as defined by RECIST v1.1\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations\n\nExclusion Criteria:\n\n* Individual with known or suspected uncontrolled CNS metastases\n* Individual with uncontrolled hypercalcemia\n* Individual with uncontrolled diabetes\n* Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant\n* Any serious unresolved toxicities from prior therapy\n* Significant cardiovascular disease\n* Recent thromboembolic event and\u002For clinically significant bleeding disorder\n* Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms\n* History of pneumonitis\u002Finterstitial lung disease\n* History of Grade ≥3 skin toxicity when receiving enfortumab vedotin\n* Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention",{"count":425,"type":21},420,[52],"The purpose of this study is to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.",[312,429,309,430,64,56,431,432,76,62,59,314,433,434],"Recurrent Solid Tumor","Urinary Bladder Neoplasm","Esophageal Cancer","Pancreatic Cancer","Renal Pelvis Cancer","Bladder Cancer",[434,436,437,438,439,440,433,441,442,443,444,445,446],"Bladder Neoplasm","Bladder Urothelial Carcinoma","Urinary Bladder Cancer","Urinary Tract Cancer","Urothelial Neoplasms","Ureter Cancer","Nectin-4","Antibody Drug Conjugate (ADC)","Triple Negative Breast Cancer (TNBC)","Non-small Cell Lung Cancer (NSCLC)","Head and Neck Squamous Cell Carcinoma (HNSCC)",{"date":384,"type":32},{"date":449,"type":32},"2024-07-01",{"date":451,"type":21},"2027-05",{"name":453,"class":39},"Eli Lilly and Company",39,{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":22,"phases":465,"briefSummary":466,"conditions":467,"keywords":480,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":503},"100483771","phase-1-rinatabart-sesutecan-rina-s-pro1184-gen1184-for-advanced-solid-tumors-gct1184-01-pro1184-001-100483771","NCT05579366","Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01\u002F PRO1184-001)","Phase 1\u002F2 Study of Rina-S in Patients With Locally Advanced and\u002For Metastatic Solid Tumors","RAINFOL-01","Inclusion Criteria:\n\nPart A and B:\n\n* Histologically or cytologically confirmed metastatic or unresectable solid malignancy including ovarian cancer (must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer), endometrial cancer, non-small cell lung cancer (Part A), EGFR-mutated NSCLC (Part B), breast cancer (hormone receptor positive, HER2-negative and triple-negative) (Part A), mesothelioma or cervical cancer (Part B).\n* Previously received therapies known to confer clinical benefit.\n* Measurable disease per RECIST v1.1 for all tumor types other than pleural mesothelioma which will use mRECIST v1.1 at baseline.\n\nPart C, E, and H:\n\nParticipants must have histologically or cytologically confirmed metastatic or unresectable epithelial ovarian cancer as specified below.\n\n* High grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (excluding endometrioid, clear cell carcinomas, mucinous, low grade, and those with a sarcomatous or neuroendocrine element)\n* Participants must have received up to 3 prior lines of therapy. Participants may have had up to to 4 prior lines of therapy are allowed if MIRV is locally approved and was used as the last line of therapy. Participants must have progressed radiographically on or after their most recent line of therapy.\n* Participants must have platinum-resistant ovarian cancer.\n* Participants must have received prior bevacizumab or approved biosimilar.\n* Participants with known or suspected deleterious germline or somatic BRCA mutations (as determined by Food and Drug Administration \\[FDA\\]-approved test in a Clinical Laboratory Improvement Amendments \\[CLIA\\]-certified laboratory; or locally approved equivalent) and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment.\n* Measurable disease per the RECIST v1.1 at baseline.\n\nPart D:\n\nCohort D1:\n\n* Participants must have platinum-sensitive ovarian cancer.\n* Participants must have received 1 to 3 prior lines of therapy.\n\nCohort D2:\n\n* Participants must have primary platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.\n* Participants with primary platinum-refractory ovarian cancer must have received ≤2 prior lines of therapy. Primary platinum-refractory ovarian cancer is defined as a lack of response or by progression within 91 days after completing front-line platinum containing therapy.\n* Participants must have received 1 to 3 prior lines of therapy for platinum-resistant ovarian cancer (PROC), and up to 4 prior lines of therapy for platinum-sensitive ovarian cancer (PSOC). Prior treatments may have included bevacizumab, PARP inhibitor, and MIRV.\n\n  * Participants with PSOC must have disease progression on or after maintenance treatment, or at least 6 months (\\>183 days) or more from the last dose of platinum-based therapy.\n\nCohort D3:\n\n• Endometrial cancer (any subtype excluding sarcoma).\n\nCohort D4:\n\n• Primary advanced or recurrent endometrial cancer (any subtype excluding sarcoma and neuroendocrine tumors).\n\nPart F and G:\n\n* Participants must have histologically or cytologically confirmed EC.\n* Recurrent progressive EC (any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy.\n* Participants must have received 1 to 3 prior lines of therapy, and must have progressed radiographically on or after their most recent line of therapy:\n* Participants must have received prior platinum-based chemotherapy and a programmed death-ligand 1 (PD-\\[L\\])1 inhibitor.\n* Participants who progress \\>12 months after completion of prior adjuvant or neoadjuvant platinum-based chemotherapy must receive 1 additional cytotoxic systemic treatment prior to enrollment in this study.\n* Hormonal therapy alone (i.e., without chemotherapy) will not be counted as a separate line of therapy.\n* Measurable disease per the RECIST Version 1.1 at baseline.\n\nPart I:\n\n* Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer (excluding clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies or low grade\u002Fborderline ovarian tumors).\n* Participants must have platinum sensitive ovarian cancer.\n* Measurable disease per the RECIST Version 1.1 at baseline.\n\nPart J:\n\n* Participants must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or neuroendocrine element.\n* Measurable disease per the RECIST Version 1.1 at baseline.\n\nPart K:\n\n* Participants must have histologically or cytologically confirmed metastatic or unresectable ovarian cancer (must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or neuroendocrine element).\n* Participants must have primary platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.\n* Measurable disease per the RECIST Version 1.1 at baseline.\n\nExclusion Criteria:\n\n* History of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids within the past 2 years, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate.\n\nNote: Other protocol-defined inclusion\u002Fexclusion may apply.",{"count":464,"type":21},884,[52,96],"This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors.\n\nParticipants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).",[468,469,470,471,61,56,472,473,474,64,475,476,477,478,479],"High Grade Epithelial Ovarian Cancer","High Grade Serous Ovarian Cancer","Primary Peritoneal Carcinoma","Fallopian Tube Cancer","Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (NSCLC)","Mesothelioma","Breast Adenocarcinoma","Hormone Receptor-positive\u002FHer2 Negative Breast Cancer","Platinum-resistant Ovarian Cancer (PROC)","Platinum Sensitive Ovarian Cancer (PSOC)","Primary Refractory Ovarian Cancer","Uterine Cancer",[481,482,483,484,485,486,487,488,489,490,238,239,491,492,493,494],"antibody-drug conjugate","folate receptor alpha","folate receptor","solid tumor","ovarian cancer","primary peritoneal carcinoma","fallopian tube cancer","endometrial cancer","non-small cell lung cancer","mesothelioma","hormone receptor-positive (HR+)\u002Fhuman epidermal growth factor receptor 2 negative (HER2-) breast cancer","topoisomerase I inhibitor","PROC","epidermal growth factor receptor (EGFR)-mutated NSCLC","2026-08-03",{"date":407,"type":32},{"date":498,"type":32},"2022-12-07",{"date":500,"type":21},"2027-10",{"name":502,"class":39},"Genmab",66,{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":510,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":22,"phases":514,"briefSummary":515,"conditions":516,"keywords":517,"overallStatus":406,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":523,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":4},"100650163","phase-2-neoadjuvant-angiogenesis-targeting-bispecific-chemoimmunotherapy-for-tnbc-100650163","NCT07743632","Neoadjuvant Angiogenesis-Targeting Bispecific Chemoimmunotherapy for TNBC","Neoadjuvant Angiogenesis-Targeting Bispecific Chemoimmunotherapy for TNBC (NeoASPECT)","NeoASPECT","Inclusion Criteria:\n\nAbility of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent\n\n18 years of age or older\n\nHistologically confirmed cT1c-T3 N0 or cT1-T3 N1-N2 triple-negative breast cancer\n\n* The invasive tumor must be hormone receptor poor, defined as both estrogen receptor (ER) and progesterone receptor staining in ≤ 10% of invasive cancer cells by IHC.\n* The invasive tumor must be HER2-negative based on the current ASCO-CAP guidelines 79.\n* Subjects with bilateral synchronous triple-negative breast cancer are eligible if they meet other eligibility criteria.\n\nNo previous ipsilateral breast surgery for the current breast cancer\n\nNo previous chemotherapy, immunotherapy, targeted therapy, endocrine therapy, or radiotherapy for the current breast cancer\n\nECOG Performance Status 0 or 1, documented within 21 days prior to the start of study treatment (Appendix A)\n\nBreast and axillary imaging (including MRI and either mammogram and\u002For ultrasound, per standard of care) within 56 days (8 weeks) prior to treatment initiation\n\nSubjects with clinically and\u002For radiographically abnormal axillary or internal mammary lymph nodes should have pathologic assessment of disease status with image-guided biopsy or fine needle aspiration unless deemed medically unsafe\n\nCo-enrollment in the PROGECT (HSC #12614) observational registry protocol\n\nArchival breast tumor tissue has been obtained or has been requested for use, which should include either a formalin-fixed paraffin-embedded (FFPE) block, or sixteen slides (fourteen 5-micron uncharged unstained slides plus either two H\\&E slides or two 5-micron charged unstained slides) - from primary breast tumor only.\n\nNeuropathy: No baseline grade 2 or above neuropathy\n\nNot pregnant, not breastfeeding, and at least one of the following applies:\n\n* Not a woman of reproductive potential as defined by institutional standards and treating physician's discretion\n* A woman of reproductive potential who agrees to follow contraceptive guidelines per institutional standards during the treatment period and for at least 3 months after the last dose of ivonescimab, or until 6 months after last dose of carboplatin or doxorubicin, 2 months after last dose of docetaxel, or 12 months after last dose of cyclophosphamide (whichever is longer).\n\nAdequate organ function, defined as follows:\n\nHematologic (assessed ≤ 21 days of treatment initiation):\n\n* Absolute neutrophil count ≥ 1,500\u002FμL (with the exception of patients with documented Fy(a-\u002Fb-) (Duffy null) immunophenotype, in which case absolute neutrophil count ≥1,200\u002FuL is allowed)\n* Platelets ≥ 100,000\u002FμL\n* Leukocytes ≥ 3,000\u002FμL\n* Hemoglobin ≥ 9.0 g\u002FdL or ≥ 5.6 mmol\u002FL (must be met without erythropoietin dependency and without erythrocyte transfusion within the last two weeks)\n\nCoagulation (assessed ≤ 21 days of treatment initiation):\n\nFor patients who are not on therapeutic anti-coagulation:\n\n* Prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5x ULN\n* Partial prothrombin time (PTT) or activated partial prothrombin time (aPTT) ≤ 1.5x ULN (unless abnormalities are unrelated to coagulopathy). Patients receiving therapeutic anti-coagulation should be on a stable dose.\n\nRenal (assessed ≤ 21 days of treatment initiation):\n\n* Creatinine ≤ 1.5 mg\u002FdL and\u002For creatinine clearance ≥ 60 mL\u002Fmin\n* Urine protein test \\\u003C2+ or 24-hour urine protein quantification \\\u003C1.0 g\n\nHepatic (assessed ≤ 21 days of treatment initiation):\n\n* Total bilirubin ≤ 1.5x ULN\n* AST(SGOT) and ALT(SPGT) ≤ 2x ULN\n* Serum albumin ≥ 3.0 g\u002FdL\n\nCardiac (assessed ≤ 56 days of treatment initiation):\n\n* Subjects with heart failure are not eligible, nor are patients with myocardial infarction, unstable angina pectoris, an arterial thrombotic event, stroke, or transient ischemic attack within the past 12 months, uncontrolled hypertension (systolic BP \\> 150 mmHg, diastolic BP \\> 100 mmHg), uncontrolled or symptomatic arrythmia, or greater than grade 2 peripheral vascular disease\n* LVEF ≥ 50% by echocardiogram or MUGA scan, per standard of care\n\nExclusion Criteria:\n\nCurrent or anticipated use of other investigational agents while participating in this study\n\nClinically or radiographically detected metastatic disease\n\nInflammatory breast cancer\n\nPrior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the treatment regimen.\n\n\\- Note: Patients with squamous cell or basal cell carcinoma of the skin, ductal carcinoma in situ (DCIS) of the breast, or carcinoma in situ (CIS) of the uterine cervix who have undergone definitive therapy are not excluded from participation\n\nHistory of allergic reactions attributed to carboplatin, docetaxel, doxorubicin, or cyclophosphamide\n\nHistory of severe (≥ grade 3) hypersensitivity to ivonescimab or any of its excipients, or to any other monoclonal antibody\n\nPrior treatment with a VEGF inhibitor or with an anti-PD-1, anti-PD-L1, anti-PD-L2 inhibitor or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA4, OX40, CD137)\n\nHistory of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to starting 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 prior to starting study treatment. The use of full-dose anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits according to institutional guidelines.\n\nPoorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy\n\nMajor surgical procedures or serious trauma within 4 weeks prior to start of study treatment, major surgical procedures planned for within 4 weeks after the first dose of study treatment, or minor local procedures within 3 days prior to start of study treatment (as determined by the investigator).\n\n\\- Note: Central venous catheterization and port implantation within 3 days prior to start of study treatment are allowed.\n\nSubject has received a live vaccine within 30 days prior to treatment initiation\n\n* Live vaccines include (but are not limited to) measles, mumps, rubella, varicella\u002Fzoster (chicken pox and shingles), yellow fever, rabies, Bacillus-Calmette-Guérin (BCG), typhoid.\n* Note: Seasonal injectable influenza vaccines are killed virus and are allowed\n\nSubject is currently receiving treatment or has received treatment with an investigational agent within four weeks prior to treatment initiation, or has used an investigational device within four weeks prior to treatment initiation\n\nHas a diagnosis of immunodeficiency or is receiving chronic steroid therapy (in doses exceeding 10 mg daily prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment\n\nActive autoimmune or lung disease that has required systemic treatment (e.g., disease-modifying agents, corticosteroids in doses exceeding 10 mg daily prednisone equivalent, immunosuppressive drugs) in the past two years.\n\n* Note: Patients using replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid therapy) are eligible\n* Note: Intermittent use of bronchodilators, inhaled corticosteroids, topical corticosteroids, or local corticosteroid injections is permitted\n\nHistory of major diseases before starting study treatment, specifically any of the following:\n\n* Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ grade 2) or unstable vascular disease (e.g., aortic aneurysm at risk of rupture, Moyamoya disease) that required hospitalization within 12 months prior to starting study treatment, or other cardiac impairment that may affect the safety evaluation of the study drug (e.g., poorly controlled arrhythmias, myocardial ischemia)\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 before starting 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 starting study treatment\n* Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before starting 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 starting study treatment\n\nCurrently has or has history of (within the past one year) non-infectious pneumonitis requiring steroids\n\nNon-infectious pneumonia requiring systemic corticosteroids within the past 30 days, or current interstitial lung disease\n\nInfection requiring systemic therapy within 2 weeks prior to starting study treatment (excluding antiviral therapy for hepatitis B or C)\n\nPeripheral neuropathy grade 2 or higher by CTCAE version 6\n\nCurrent or history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)\n\nKnown history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation\n\nKnown history of human immunodeficiency virus (HIV) infection.\n\n\\- Note: Patients with controlled viral load are eligible.\n\nActive hepatitis B (defined as HBsAg reactive) or hepatitis C (detectable HCV RNA or positive for HCV antibody)\n\n* Note: Patients with active hepatitis B are eligible if on appropriate antiviral therapy with acceptable tolerability for 4 weeks prior to starting study treatment, with stable or declining levels of hepatitis B DNA by polymerase chain reaction testing.\n* Note: Testing for hepatitis B and C is not required unless mandated by local health authority\n\nHistory or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of this study, interfere with the subject's participation for the full duration of the study, or it is not in the best interest of the subject to participate, in the opinion of the treating investigator\n\nPregnancy, breastfeeding or planning to breastfeed during study treatment, or expecting to conceive within the projected duration of the study, starting with the screening visit through 90 days after the last dose of trial treatment. There is a potential for congenital abnormalities and for this regimen to harm breastfeeding infants.\n\nSubject is a female of reproductive potential per institutional guidelines and treating physician's discretion and within 24 hours of starting treatment:\n\n* Serum pregnancy test is positive, or\n* Urine pregnancy test is positive or cannot be confirmed as negative, and serum pregnancy test has not been done or is positive\n* Note: In the event that 24 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication.",{"count":513,"type":21},110,[96],"This study will test the effectiveness of two standard neoadjuvant chemotherapy regimens plus an investigational drug (ivonescimab) that has dual action as both immunotherapy and therapy targeting the tumor's blood supply. This investigational drug is called ivonescimab.",[235,64],[518,519,520,521,522],"Tumor-infiltrating lymphocytes","Neoadjuvant chemotherapy","Neoadjuvant immunotherapy","Angiogenesis","VEGF",{"date":407,"type":32},{"date":525,"type":21},"2026-09",{"date":527,"type":21},"2033-12",{"name":529,"class":169},"University of Kansas Medical Center",{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":536,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":538,"targetDuration":4,"studyType":22,"phases":540,"briefSummary":541,"conditions":542,"keywords":546,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":549,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":555,"locationsCount":557},"100619124","phase-2-evolutionary-clinical-trial-for-novel-biomarker-driven-therapies-100619124","NCT07340541","Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies","TBCRC Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies (EVOLVE-BDT)","EVOLVE-BDT","Inclusion Criteria:\n\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.\n* Subject is willing and able to comply with study procedures based on the judgement of the investigator.\n* Age ≥ 18 years of age at the time of consent\n* ECOG Performance Status of 0-2 (see APPENDIX A: ECOG Performance Status Scale).\n* Patients must fulfill all eligibility criteria outlined in the LCCC2521 Parent Protocol and consented to LCCC2521 Parent Protocol\n\nExclusion Criteria:\n\n* Inaccessible metastatic lesion to research biopsy\n* Subject has already initiated 2nd line therapy\n* Concurrent disease or condition that in the opinion of the treating oncologist renders the patient inappropriate for study participation",{"count":539,"type":21},700,[96],"This is a multicenter, multi-arm, biomarker-stratified trial designed to evaluate biomarker-directed therapies in patients with estrogen receptor-positive\u002Fhormone receptor-negative (ER+\u002FHR-) and triple-negative (TN) metastatic breast cancer (MBC). The trial integrates both retrospective and prospective data collection, including archival tumor tissue, medical record abstraction, and prospective tumor and blood sampling prior to initiation of protocol directed treatment. Based on biomarker subtype, participants will receive standard of care therapy. Liquid biopsy will be collected on Cycle 2 Day 1, and then liquid biopsy, imaging and clinical data will be collected at each re-staging. Treatment will continue until discontinuation for progression, toxicity or at the discretion of the treating physician.",[235,543,64,544,545],"Metastatic Breast Cancer","Estrogen-receptor-positive Breast Cancer","Hormone Receptor Negative Breast Carcinoma",[547,548],"biomarker directed therapies","biomarker stratified trial",{"date":550,"type":32},"2026-07-31",{"date":552,"type":32},"2026-02-16",{"date":554,"type":21},"2031-06-02",{"name":556,"class":169},"UNC Lineberger Comprehensive Cancer Center",4,{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":564,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":207,"minAge":18,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":22,"phases":568,"briefSummary":569,"conditions":570,"keywords":571,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":576,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":583},"100522332","phase-3-neoadj-therapy-comparing-sacituzumab-govitecan-sg-vs-sgpembrolizumab-in-low-risk-triple-neg-ebc-adapt-tn-iii-100522332","NCT06081244","NeoAdj. Therapy Comparing Sacituzumab Govitecan (SG) vs. SG+Pembrolizumab in Low-risk, Triple-neg. EBC (ADAPT-TN-III)","NeoAdjuvant Dynamic Marker - Adjusted Personalized Therapy Comparing Sacituzumab Govitecan Versus Sacituzumab Govitecan+Pembrolizumab in Low-risk, Triple-negative Early Breast Cancer (ADAPT-TN-III)","ADAPT-TN-III","Inclusion Criteria:\n\n1. ER + PR negative or low positive (≤10% positive cells in IHC), and HER2 negative (i.e., IHC 0 - 1+ or IHC 2+ with FISH negative) breast cancer\n2. All patients, independent from gender\n3. ≥18 years at diagnosis\n4. Histologically confirmed unilateral, primary invasive carcinoma of the breast Note: bilateral, multicentric, or multifocal carcinoma may be included, if there is a clear target lesion, that is subject to treatment decisions and solely evaluated and documented for study purposes.\n5. Clinical stage I: cT1a-c, cN0 (clinical stage II only, if patient does not qualify for neoadjuvant polychemotherapy+PEM, e.g., elderly population, per investigator´s decision)\n6. No clinical evidence for distant metastasis (M0)\n7. Tumour block available for central pathology review\n8. Performance Status ECOG ≤ 1 or KI ≥ 80%\n9. Negative pregnancy test (urine or serum) within 7 days prior to registration in premenopausal patients\n10. Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements\n11. The patient must be willing and able to comply with the requirements and restrictions in this protocol and accessible for treatment and follow-up\n12. Laboratory requirements:\n\n    * Leucocytes ≥3.5 109\u002FL,\n    * Neutrophils \\> 1.5 109\u002FL,\n    * Platelets ≥100 109\u002FL,\n    * Haemoglobin ≥10 g\u002FdL,\n    * AP \\\u003C 5.0 ULN,\n    * AST ≤2.5 x ULN,\n    * ALT ≤2.5 x ULN,\n    * Total bilirubin ≤1 x ULN,\n    * Creatinine ≤1.5 × ULN OR clearance ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN\n13. Clinical assessments:\n\n    • LVEF within normal limits of each institution, measured by echocardiography and normal ECG (within 42 days prior to treatment)\n14. The following age-specific requirements apply:\n\n    * Women aged \\\u003C50 years will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the site.\n    * Women aged ≥ 50 years will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments.\n15. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for women of child-bearing potential if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to randomization\u002Fstudy enrolment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.\n16. Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception, presented in Table 1 (see Section 4.4.2), from the time of screening and must agree to continue using such precautions for 7 months after the last dose of IMP. Not all methods of contraception are highly effective. Female patients must refrain from breastfeeding while on study and for 7 months after the last dose of IMP. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic, or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable.\n17. Female patients must not donate, or retrieve for their own use, ova from the time of randomisation and throughout the study treatment period, and for at least 7 months after the final study drug administration. They should refrain from breastfeeding throughout this time. Preservation of ova may be considered prior to enrolment in this study.\n18. A male participant must agree to use a contraception as detailed in Appendix C of this protocol during the treatment period and for at least 7 months after the last dose of study treatment and refrain from donating sperm during this period.\n\nExclusion Criteria:\n\n1. Known hypersensitivity reaction to the compounds or incorporated substances of the IMPs\n2. Prior malignancy with a disease-free survival of \\\u003C 5 years, except curatively treated basalioma of the skin or pTis of the cervix uteri\n3. Any history of invasive breast cancer\n4. Previous or concurrent treatment with cytotoxic agents for any non-oncological reason unless clarified with sponsor\n5. Concurrent treatment with other experimental drugs\n6. Participation in another interventional clinical trial with or without any investigational not marketed drug within 30 days prior to study entry\n7. Concurrent pregnancy; patients of childbearing potential or potentially childbearing partners of male patients must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment\n8. Breast feeding woman\n9. Reasons indicating risk of poor compliance\n10. Patients not able to consent\n11. Known polyneuropathy ≥ grade 2\n12. Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study including recovery from major surgery, autoimmune disease, known psychiatric\u002Fsubstance abuse disorders, acute cystitis, ischuria, and chronic kidney disease\n13. Uncontrolled infection requiring i.v. antibiotics, antivirals, or antifungals\n14. History of pneumonitis\n15. Active primary immunodeficiency, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Patients should be tested for HIV prior to randomisation if required by local regulations or ethics committee (EC).\n16. Have active hepatitis B virus (HBV) or hepatitis C virus (HCV). In patients with a history of HBV or HCV, patients with detectable viral loads will be excluded.\n\n    * Patients who test positive for hepatitis B surface antigen (HBsAg). Patients who test positive for hepatitis B core antibody (anti-HBc) will require HBV DNA by quantitative polymerase chain reaction (PCR) for confirmation of active disease.\n    * Patients who test positive for HCV antibody will require HCV RNA by quantitative PCR for confirmation of active disease. Patients with a known history of HCV or a positive HCV antibody test will not require a HCV antibody at screening and will only require HCV RNA by quantitative PCR for confirmation of active disease.\n17. Patients who test positive for HIV antibody.",{"count":567,"type":21},348,[24],"TNBC is known for poor prognosis, aggressive patterns of disease, and significant molecular heterogeneity. (Neo)adjuvant chemotherapy (NACT) is standard of care in all node-positive and in node-negative patients with a tumour size \\>5 mm according to current National Comprehensive Cancer Network (NCCN) guidelines. However, TNBC patients with lower stage disease do clearly have a better prognosis compared to more advanced stages. Patients with stage I-II node-negative disease have 3-5 year iDFS rates of 80-90% (with majority of relapses within the first three years) as shown in several trials.Although survival results appear much better in the lower vs. higher stages, there is a high clinical need in this most common group of TNBC patients in Western Europe and USA.",[64],[75,572,573,345,574,575],"Early breast cancer","Sacituzumab govitecan","chemotherapy","low recurrence risk",{"date":495,"type":32},{"date":578,"type":32},"2024-10-10",{"date":580,"type":21},"2029-09",{"name":582,"class":169},"West German Study Group",43,{"id":585,"slug":586,"hasResults":12,"nctId":587,"briefTitle":588,"officialTitle":589,"acronym":4,"eligibilityCriteria":590,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":591,"enrollmentInfo":592,"targetDuration":4,"studyType":22,"phases":594,"briefSummary":595,"conditions":596,"keywords":599,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":608,"completionDateStruct":610,"leadSponsor":612,"locationsCount":614},"100559289","phase-1-phase-i-study-of-177lulu-nns309-in-patients-with-pancreatic-lung-breast-and-colorectal-cancers-100559289","NCT06562192","Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers","Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Patients with one of the following indications:\n* Locally advanced unresectable or metastatic PDAC with disease progression following, or intolerance to cytotoxic chemotherapy, unless patient was ineligible to receive such therapy\n* Locally advanced unresectable or metastatic NSCLC without any actionable genomic alterations with disease progression following, or intolerance to chemotherapy and immunotherapy, unless patient was ineligible to receive such therapy, or locally advanced unresectable or metastatic NSCLC with an actionable genomic alteration with disease progression following, or intolerance to targeted therapy, unless patient was ineligible to receive such therapy\n* Locally advanced unresectable or metastatic HR+\u002FHER2- ductal or lobular BC with disease progression following, or intolerance to, at least 2 lines of therapy, unless patient was ineligible to receive such therapy\n* Locally advanced unresectable or metastatic TNBC with disease progression following, or intolerance to, at least 2 lines of therapy, unless patient was ineligible to receive such therapy\n* Locally advanced or metastatic unresectable CRC with disease progression following, or intolerance to cytotoxic chemotherapy, unless patient was ineligible to receive such therapy. Patients with known microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status must also have had disease progression following, or intolerance to immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy\n* Patients must have lesions showing 68Ga-NNS309 uptake\n\nExclusion Criteria:\n\n* Absolute neutrophil count (ANC) \\\u003C 1.5 x 10\\^9\u002FL, hemoglobin \\\u003C 9 g\u002FdL, or platelet count \\\u003C 100 x 10\\^9\u002FL\n* QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec\n* Calculated estimated glomerular filtration rate \\\u003C 60 mL\u002Fmin\u002F1.73m2\n* Unmanageable urinary tract obstruction or urinary incontinence\n* Radiation therapy within 4 weeks prior to the first dose of \\[177Lu\\]Lu-NNS309\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","100 Years",{"count":593,"type":21},162,[52],"The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \\[177Lu\\]Lu-NNS309 and the safety, dosimetry and imaging properties of \\[68Ga\\]Ga-NNS309 in patients aged ≥ 18 years with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+\u002FHER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC) and colorectal cancer (CRC).",[597,56,598,64,58],"Pancreatic Ductal Adenocarcinoma","HR+\u002FHER2- Ductal and Lobular Breast Cancer",[600,489,238,601,602,603,604],"pancreatic ductal adenocarcinoma","colorectal cancer","radioligand therapy (RLT)","[177Lu]Lu-NNS309","[68Ga]Ga-NNS309","2026-07-28",{"date":607,"type":32},"2026-07-29",{"date":609,"type":32},"2024-10-15",{"date":611,"type":21},"2031-01-16",{"name":613,"class":39},"Novartis Pharmaceuticals",29,{"id":616,"slug":617,"hasResults":12,"nctId":618,"briefTitle":619,"officialTitle":620,"acronym":4,"eligibilityCriteria":621,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":622,"targetDuration":4,"studyType":22,"phases":624,"briefSummary":625,"conditions":626,"keywords":629,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":638,"locationsCount":170},"100542761","phase-1-study-of-autologous-car-t-cells-targeting-b7-h3-in-tnbc-ic9-carb7-h3-t-cells-100542761","NCT06347068","Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells","Study of Administration of T Cells Expressing B7-H3 Specific Chimeric Antigen Receptors and Containing the Inducible Caspase 9 Safety Switch in Subjects With Triple Negative Breast Cancer","Inclusion Criteria:\n\nUnless otherwise noted, subjects must meet all of the following criteria to participate in in all phases of the study:\n\n1. Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information explained to, understood by and signed by the subject or legally authorized representative.\n2. Age ≥ 18 years at the time of consent.\n3. Karnofsky score of \\> 60% (see APPENDIX VI- Karnofsky Scale))\n4. Histologically confirmed TNBC (ER-, PR-, HER2-negative)\n\n   1. ER- and PR-negative: defined as \\\u003C 1% staining by immunohistochemistry (IHC)\n   2. HER2-negative: defined as IHC 0-1+ or fluorescence in situ hybridization (FISH) ratio \\\u003C 2.0\n\nExclusion Criteria:\n\n1. Patients with a history of symptomatic CNS involvement or multiple metastases requiring whole-brain radiation.\n2. Subjects with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n3. Subject does not have a measurable and or evaluable disease as defined by RECIST 1.1",{"count":623,"type":21},42,[52],"This phase 1, single-center, open-label study explores the safety of escalating doses of chimeric antigen receptor T cells (CAR-T) cells in subjects with relapsed\u002Frefractory triple-negative breast cancer (TNBC).",[235,627,628,64],"Relapse","Resistant Cancer",[630,631],"cellular therapy","biologic therapy","2026-07-27",{"date":605,"type":32},{"date":635,"type":32},"2024-06-27",{"date":637,"type":21},"2030-05",{"name":556,"class":169},{"id":640,"slug":641,"hasResults":12,"nctId":642,"briefTitle":643,"officialTitle":644,"acronym":4,"eligibilityCriteria":645,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":646,"targetDuration":4,"studyType":22,"phases":648,"briefSummary":649,"conditions":650,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":654,"startDateStruct":655,"completionDateStruct":657,"leadSponsor":658,"locationsCount":199},"100527661","phase-1-a-phase-1-of-ctx-8371-in-patients-with-advanced-malignancies-100527661","NCT06150664","A Phase 1 of CTX-8371 in Patients With Advanced Malignancies","A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of CTX-8371 in Patients With Advanced Malignancies","Inclusion Criteria:\n\n1. Age 18 years or older\n2. Patients must have a histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic disease that is relapsed\u002Frefractory to standard therapy or for which no effective standard therapy is available, including\n\n   1. Malignant Melanoma (MM)\n\n      * Patients who have progressed after a minimum of 2 doses of a PD-1\u002FPD-L1 treatment. Study enrollment (C1D1) must be within 12 weeks of the last dose of the anti-PD-1\u002FPD-L1 blocking antibody\n      * Patients must have had prior testing for BRAF V600 mutations. Patients with BRAF V600 activating mutation must have received prior therapy with a BRAF\u002FMEK inhibitor\n      * Uveal and mucosal melanoma are excluded\n   2. Head and Neck squamous cell carcinoma (HNSCC)\n\n      * HNSCC of oral cavity, oropharynx, hypopharynx, or larynx\n      * Patients who have progressed after a minimum of 2 doses of a PD-1\u002FPD-L1 treatment. Study enrollment (C1D1) must be within 12 weeks of the last dose of the anti-PD-1\u002FPD-L1 blocking antibody\n      * Patients must have received prior treatment with platinum-based chemotherapy\n   3. Non-Small Cell Lung Cancer (NSCLC)\n\n      * Patients who have progressed after a minimum of 2 doses of a PD-1\u002FPD-L1 treatment. Study enrollment (C1D1) must be within 12 weeks of the last dose of the anti-PD-1\u002FPD-L1 blocking antibody\n      * Patients must have received prior treatment with platinum-based chemotherapy\n   4. Triple Negative Breast Cancer (TNBC)\n\n      * ER\u002FPR and HER2 status should be defined by ASCO\u002FCAP guidelines (JCO Allison et al 2020)\n      * Patients with HER2-low cancers (HER2 IHC 1+ or 2+\u002FISH negative) are excluded\n      * Patients must have received prior sacituzumab govitecan and if PD-L1 ≥10% by CPS pembrolizumab with chemotherapy\n   5. Classical Hodgkin Lymphoma (HL)\n\n      * Patients must have received at least two prior systemic therapies including brentuximab vedotin (if eligible) and a prior PD-1 inhibitor\n      * Patients must have experienced less than a CR (according to Lugano criteria) to anti- PD-1 treatment\n   6. (Cohort 2 Dose Expansion): Non-Small Cell Lung Cancer (NSCLC)\n\n      * Patients who have progressed after a minimum of 2 doses of a PD-1\u002FPD-L1 treatment\n      * Patients must have received prior treatment with platinum-based chemotherapy\n   7. (Cohort 2 Dose Expansion) Triple Negative Breast Cancer (TNBC)\n\n      * ER\u002FPR and HER2 status should be defined by ASCO\u002FCAP guidelines (JCO Allison et al 2020)\n      * Patients must have received prior sacituzumab govitecan and if PD-L1 ≥10% by CPS pembrolizumab with chemotherapy\n      * Patients with HER2-low tumors (HER2 IHC 1+ or 2+\u002FISH negative) need to have received fam-trastuzumab deruxtecan (Enhertu)\n   8. (Cohort 2 Dose Expansion) Classical Hodgkin's Lymphoma (HL)\n\n      * Patients must have received at least two prior systemic therapies including brentuximab vedotin (if eligible) and a prior PD-1 inhibitor.\n      * Patients must have received at least 12 weeks of treatment with a PD-1\u002FPD-L1 inhibitor as a monotherapy or in combination and had at least stable disease or progressive disease (PD) with overall clinical benefit.\n3. Patients with NSCLC, MM, TNBC, and HNSCC must have measurable disease per RECIST 1.1. Patients with HL must have at least one measurable lesion \\> 1.5 cm for nodal, \\> 1.0 cm for extranodal FDG-avid disease by the Lugano (2014) response criteria. Tumor sites that are considered measurable must not have received prior radiation\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n5. Adequate bone marrow function defined by absolute neutrophil (ANC) of ≥ 1.5×109\u002FL, platelet count of ≥ 100.0×109\u002FL, and hemoglobin of ≥ 9.0 g\u002FdL (with or without transfusion)\n\n   a. (Cohort 2 Dose Expansion) Adequate bone marrow function defined by absolute neutrophil (ANC) of ≥ 1.5×109\u002FL, platelet count of ≥ 100.0×109\u002FL, and hemoglobin of ≥ 9.0 g\u002FdL (with or without transfusion) within 2 weeks from the first dose of CTX-8371.\n\n   \\- Blood transfusion is not allowed within 2 weeks from the first dose of CTX-8371\n6. Adequate hepatic function defined as serum total bilirubin ≤ 1.5 × ULN, AST\u002FALT ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases)\n7. Adequate renal function defined as creatinine clearance ≥ 30mL\u002Fmin by Cockcroft-Gault equation\n8. Female patients must be surgically sterile (or have a monogamous partner who is surgically sterile) or be at least 2 years postmenopausal or commits to use 2 acceptable forms of birth control (defined as the use of an intrauterine device (IUD), a barrier method with spermicide, condoms, any form of hormonal contraceptives) or abstinence for the duration of the study and for 4 months following the last dose of study treatment. Male patients must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study and for 4 months following the last dose of study treatment\n9. Female patients who are women of childbearing potential (WOCBP) must have a negative serum pregnancy test at Screening within 7 days of dosing with CTX-8371\n10. Last dose of previous PD-1 or PD-L1 therapy ≥ 28 days, other anticancer therapy \\> 21 days (or 2 half-lives for proteins, whichever is longer), radiotherapy \\>21 days (concurrent localized palliative radiotherapy is allowed during CTX-8371 treatment), or surgical intervention \\>21 days prior to the first dose of CTX-8371\n11. Resolution of all prior anti-cancer therapy toxicities ≤ Grade 2\n12. Life expectancy ≥ 12 weeks\n13. Capable of understanding and complying with protocol requirements\n14. Signed and dated institutional review board (IRB)\u002Findependent ethics committee (IEC)-approved informed consent form (ICF) before any protocol-directed screening procedures are performed\n\nExclusion Criteria:\n\n1. Developed clinically significant adverse reaction to PD-1 or PD-L1 therapy, including immune related adverse reactions, which led to discontinuation of treatment\n2. Systemic therapy with immunosuppressive agents within 7 days before the start of CTX-8371 treatment. Topical, intranasal, intraocular, or inhaled corticosteroids and physiologic replacement for patients with adrenal insufficiency are allowed\n3. Patient is a pregnant or lactating WOCBP\n4. Prior organ transplantation\n5. Patients with evidence of active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection. Patients with positive HBsAg and\u002For detectable HBV DNA are eligible only if adequately controlled on antiviral therapy according to institutional standards and liver function eligibility criteria are also met. HCV patients showing sustained viral response or patients with immunity to HBV infection may enroll.\n6. Active autoimmune disease or medical conditions requiring chronic steroid (i.e., \\> 10 mg\u002Fday prednisone or equivalent) or immunosuppressive therapy. Patients with a prior history of autoimmune disease may be eligible following discussion with the Medical Monitor\n7. History of primary malignancy other than the malignancy under study will be excluded, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\>90%). Prior malignancy history will be evaluated on a case-by-case basis by the Sponsor Medical Monitor.\n8. Symptomatic or uncontrolled central nervous system and brain metastasis or active leptomeningeal disease. Patients with equivocal findings or with confirmed brain metastases are eligible for the study provided that they are asymptomatic and radiologically and neurologically stable without the need for corticosteroid treatment or seizure prophylaxis for ≥4 weeks before the first dose of study drug. Prior treatment with either surgery or radiation is permitted and all patients with a history of CNS or brain lesions require imaging during screening to confirm stability.\n9. Other medical condition that in the opinion of the Investigator and\u002For Sponsor Medical Monitor may interfere with the conduct and\u002For interpretation of the current study, including:\n\n   * Congestive heart failure (\\> New York Heart Association Class II), active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or clinically significant cardiac arrhythmias\n   * QTc interval (using Fridericia correction calculation) \\> 480 msec",{"count":647,"type":21},85,[52],"This is a Phase 1, open-label, first-in-human study of CTX-8371 administered as a monotherapy in patients with metastatic or locally advanced malignancies. The study will be conducted in 2 cohorts: Dose Escalation and Dose Expansion.",[651,64,652,59,653],"Non Small Cell Lung Cancer","Hodgkin Lymphoma","Malignant Melanoma",{"date":605,"type":32},{"date":656,"type":32},"2024-03-19",{"date":451,"type":21},{"name":659,"class":39},"Compass Therapeutics",{"id":661,"slug":662,"hasResults":12,"nctId":663,"briefTitle":664,"officialTitle":665,"acronym":666,"eligibilityCriteria":667,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":668,"targetDuration":4,"studyType":22,"phases":670,"briefSummary":671,"conditions":672,"keywords":673,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":678,"lastUpdatePostDateStruct":679,"startDateStruct":681,"completionDateStruct":683,"leadSponsor":685,"locationsCount":687},"100522112","phase-2-pembrolizumab-and-chemotherapy-treatment-or-no-treatment-guided-by-the-level-of-tils-in-resected-early-stage-tnbc-100522112","NCT06078384","Pembrolizumab and Chemotherapy Treatment or no Treatment Guided by the Level of TILs in Resected Early-stage TNBC","Adjuvant Pembrolizumab and Chemotherapy or Surveillance in Early Triple Negative breAst Cancer With High Stromal Tumor-infiltrating Lymphocytes (TILs) Score","ETNA","Inclusion Criteria:\n\n1. Understand, sign, and date the written informed consent form prior to any protocol- specific procedures performed,\n2. Men and women aged ≥ 18 years,\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1,\n4. Histologically confirmed and radically removed pT1b\u002Fc N0M0 TNBC as defined according to AJCC TNM stage-8th version,\n\n   * Histologically documented TNBC (negative HER2, ER, and PgR status). HER2 negativity is defined by local laboratory assessment using in situ hybridization and immunohistochemistry assays as per ASCO\u002FCAP criteria and ER\u002FPgR negativity is defined by local laboratory assessment \\\u003C 10% using immunohistochemistry assays,\n   * Bilateral and\u002For multifocal primary tumor is allowed and the tumor with the most advanced T stage should be used to asses for eligibility. If multifocal tumor, a pathologic confirmation of TNBC is required for each focus,\n5. Adequately excised breast cancer: subjects must have undergone either breast- conserving surgery or mastectomy\u002Fnipple- or skin-sparing mastectomy.\n\n   * For subjects who undergo breast-conserving surgery, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. Reresections to ensure no ink on tumor margins are allowed. Subjects with margins positive for lobular carcinoma in situ (LCIS) are eligible without additional resection.\n   * For subjects who undergo mastectomy\u002Fnipple- or skin-sparing mastectomy, margins must be free of gross residual tumor. It is recommended that subjects should have a negative microscopic margin in accordance with local pathology protocol,\n6. Have had sentinel lymph node biopsy (SLNB) and\u002For axillary lymph node dissection (ALND) for evaluation of pathologic nodal status.\n\n   Axillary nodal dissection(s) should yield a total of at least six nodes (including the axillary lymph nodes resected at the SLNB plus the lymph nodes collected at the axillary nodal dissection),\n7. At least 4 weeks but no more than 12 weeks between definitive breast surgery (or the last surgery with curative intent if additional resection is required for breast cancer) and treatment initiation for cohort 1 and no more than 12 weeks for cohort 2,\n8. Centrally assessed TILs score from surgical formalin-fixed paraffin embedded (FFPE) tumor sample, using an H\\&E stained diagnostic digital slide, according to the most recent International TILs Working Group guidelines,\n\n   * Cohort 1 will include patients aged \\> 40 years with 30% ≤ sTILs \\\u003C 50% and those aged\n\n     * 40 years with 30% ≤ sTILs \\\u003C 75%\n   * Cohort 2 will include patients aged \\> 40 years with sTILs ≥ 50% and those aged ≤ 40 years with sTILs ≥ 75%\n9. Women of childbearing potential have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication for cohort 1 and within 7 days of inclusion for cohort 2,\n10. Women of childbearing potential must agree to use protocol-specified method(s) of contraception for 3 years after patient inclusion. Men subjects who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception during trial treatments and for at least 6 months after the last dose of trial treatments.\n\n    Females of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year,\n11. Patients affiliated to the social security system (or equivalent)- France only,\n12. Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.\n\n    Additional inclusion criteria for subjects of cohort 1:\n13. Left ventricular ejection fraction (LVEF) of ≥ 50% as assessed by echocardiogram or cardiac scintigraphy,\n14. Demonstrate adequate organ function within 7 days of inclusion\n\n    * Absolute Neutrophil Count (ANC) ≥ 1,500 \u002FµL\n    * Platelets ≥ 100,000 \u002FµL\n    * Hemoglobin ≥ 9 g\u002FdL\n    * Creatinine clearance ≥ 30 mL\u002Fmin for subject with creatinine levels \\> 1.5 x institutional upper limit of normal (ULN)\n    * Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN\n    * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN\n    * Albumin ≥ 3.0 g\u002FdL\n    * Lactate dehydrogenase (LDH) \\\u003C 2.5 X ULN\n    * International normalized ratio\u002Fpartial thromboplastin time (INR\u002FPTT) ≤ 1.5 x ULN (unless subject is receiving anticoagulant therapy as long as prothrombin time (PT) or PTT is within therapeutic range of intended use of anticoagulants)\n    * Thyroid stimulating hormone (TSH), free T4 (FT4), and free T3 (FT3) within normal ranges\n    * Cortisol at 8 AM within normal ranges\n    * Lipase and amylase \\\u003C 3 ULN\n    * Fasting plasma glucose ≤ 120 mg\u002Fdl or 6.7 mmol\u002FL\n    * Troponin within normal range\n\nExclusion Criteria:\n\n1. History of invasive malignancy ≤ 3 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer,\n2. Having received prior chemotherapy or targeted therapy within the past 12 months,\n3. Has a prior history of DCIS and\u002For LCIS that was treated with any form of systemic, hormonal therapy, or radiotherapy to the ipsilateral breast; subjects who had their DCIS\u002FLCIS treated only with surgery and\u002For contralateral DCIS treated with radiotherapy are allowed to enter the study,\n4. Having received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agents or with an agent directed to another co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137),\n5. Treatment with systemic immunostimulatory agents (including, but not limited to, interferons, interleukin-2) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to inclusion,\n6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive medications (including prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \\[anti-TNF\\] alpha agents) within 7 days prior to inclusion:\n\n   * Subjects who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled in the study\n   * The use of inhaled corticosteroids and mineralocorticoids is allowed,\n7. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment; subjects with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are eligible if:\n\n   * Rash must covers \\\u003C10% of body surface area.\n   * Disease is well controlled at baseline and requires only low-potency topical Corticosteroids and no acute exacerbations requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or oral corticosteroids occurred within the previous 12 months,\n8. Has a known history of Human Immunodeficiency Virus (HIV),\n9. Prior allogeneic stem cell or solid organ transplant,\n10. Has a known history of active Bacillus Tuberculosis,\n11. Patients with any other disease or illness which requires hospitalisation or is incompatible with the trial treatment are not eligible,\n12. Pregnant women or breastfeeding or expecting to conceive within the projected duration of the study, from the inclusion visit until the end of the 3 years follow up. Men subjects who engage in heterosexual intercourse and refuse to use protocol-specified method(s) of contraception during trial treatments and for at least 6 months after the last dose of trial treatments,\n13. Patients unable to comply with trial obligations for geographic, social, or physical reasons, or who are unable to understand the purpose and procedures of the trial,\n14. Person deprived of their liberty or under protective custody or guardianship,\n15. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n\n    Additional non-inclusion criteria for subjects of cohort 1:\n16. Has cardiac dysfunction as defined by any of the following prior to inclusion:\n\n    * History of NCI-CTCAE v5.0 Grade \\> 3 symptomatic congestive heart failure or New York Heart Association (NYHA) criteria Class II,\n    * Angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease,\n    * Significant symptoms (≥ Grade 2) relating to left ventricular dysfunction or cardiac ischemia,\n17. Has a known hypersensitivity (≥ Grade 3) to the components of the study therapy or its analogs,\n18. Has received a live vaccine or live-attenuated vaccine within 30 days of the first dose of study treatment,\n19. Concurrent active Hepatitis B virus (HBV; defined as HBsAg positive and\u002For detectable HBV DNA) and Hepatitis C virus (HCV; defined as anti-HCV Ab positive and detectable HCV RNA) infection,\n20. Severe infections within 4 weeks prior to initiation of study treatment, including, hospitalization for complications of infection, bacteremia, or severe pneumonia,\n21. Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment; subjects receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection) are eligible,\n22. Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during study treatment,\n23. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has a current pneumonitis\u002Finterstitial lung disease,\n24. Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 4 weeks of the first dose of treatment in this current trial.",{"count":669,"type":21},354,[96],"Triple-negative breast cancer (TNBC) is a group of tumors that occurs mainly in young, premenopausal women and accounts for 10-20% of breast cancers. Over the past decade, the incidence of women diagnosed with early-stage TNBC has significantly increased due to the widespread use of screening mammography. Treatment of patients with localized TNBC mainly involves surgery and (neo)adjuvant chemotherapy with or without radiotherapy. However, the benefit of chemotherapy may be controversial in patients with early-stage TNBC defined by small size and absence of lymph node involvement, and with significant tumor lymphocyte infiltration.\n\nThe ETNA study is a phase II trial designed to evaluate a chemotherapy de-escalation strategy in patients with TNBC T1b\u002Fc N0M0 and stromal TILs (sTILs) ≥ 30%. ETNA comprises two cohorts defined according to the level of TILs and the age of patients. Patients aged \\> 40 years with 30% ≤ sTILs \\\u003C 50% and those aged ≤ 40 years with 30% ≤ sTILs \\\u003C 75% will be included in the cohort 1 and will receive adjuvant pembrolizumab 200 mg every three weeks for 9 cycles and Paclitaxel 80 mg\u002Fm² weekly for 12 cycles. Patients aged \\> 40 years with sTILs ≥ 50% and those aged ≤ 40 years with sTILs ≥ 75% will be included in cohort 2 and will not receive adjuvant treatment, they will undergo standard surveillance every six months.",[183],[674,675,676,677],"Breast cancer","De-escalation","Immunotherapy","Chemotherapy","2026-07-23",{"date":680,"type":32},"2026-07-24",{"date":682,"type":32},"2024-12-27",{"date":684,"type":21},"2032-01-01",{"name":686,"class":169},"UNICANCER",44,{"id":689,"slug":690,"hasResults":12,"nctId":691,"briefTitle":692,"officialTitle":693,"acronym":4,"eligibilityCriteria":694,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":48,"enrollmentInfo":695,"targetDuration":4,"studyType":22,"phases":697,"briefSummary":698,"conditions":699,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":700,"lastUpdatePostDateStruct":701,"startDateStruct":702,"completionDateStruct":704,"leadSponsor":706,"locationsCount":170},"100552293","phase-2-a-study-of-bl-b01d1pd-1-monoclonal-antibody-in-patients-with-unresectable-locally-advanced-or-recurrent-metastatic-triple-negative-breast-cancer-100552293","NCT06471205","A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer","A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody Combination Therapy in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent and follow the requirements of the protocol;\n2. Age: ≥18 years old and ≤75 years old;\n3. Expected survival time ≥3 months;\n4. ECOG 0 or 1;\n5. Subjects with histologically and\u002For cytologically confirmed, inoperable locally advanced or recurrent or metastatic triple-negative breast cancer;\n6. Patients should not have received previous systemic therapy for unresectable, locally advanced, recurrent, or metastatic triple-negative breast cancer;\n7. A archived tumor tissue specimen or fresh tissue specimen of the primary or metastatic lesion within 2 years must be provided;\n8. Must have at least one place in accordance with RECIST v1.1 define measurable lesions;\n9. No blood transfusion, no use of cell growth factors and\u002For platelet raising drugs within 14 days before screening, and the organ function level must meet the requirements;\n10. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;\n11. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, the serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.\n\nExclusion Criteria:\n\n1. ADC drugs that have received topoisomerase I inhibitors as small molecule toxins;\n2. Palliative radiotherapy within 2 weeks before the first dose;\n3. Patients with checkpoint inhibitors prior to neoadjuvant\u002Fadjuvant chemotherapy;\n4. Use of an immunomodulatory drug within 14 days before the first dose of study drug;\n5. The history of severe cardiovascular and cerebrovascular diseases in the past six months was screened;\n6. QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;\n7. Active autoimmune and inflammatory diseases;\n8. Receiving long-term systemic corticosteroid therapy, etc., before the first dose;\n9. Other malignant tumors that progressed or required treatment within 5 years before the first dose;\n10. Presence of: a) poorly controlled diabetes mellitus before starting study treatment; b) severe complications associated with diabetes mellitus; c) a glycated hemoglobin level of 8% or more; d) hypertension poorly controlled by two antihypertensive drugs; e) history of hypertensive crisis or hypertensive encephalopathy;\n11. Present grade ≥2 radiation pneumonitis according to the RTOG\u002FEORTC definition; Patients with current ILD;\n12. Complicated with pulmonary diseases leading to clinically severe respiratory impairment;\n13. 6 months prior to screening needs treatment intervention unstable thrombotic events;\n14. Patients with active central nervous system metastases;\n15. Patients with massive or symptomatic effusions or poorly controlled effusions;\n16. Allergic history to recombinant humanized antibody or human-mouse chimeric antibody or allergic to any excipients of the test drug;\n17. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;\n18. HIV antibody positive, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n19. Serious infection within 4 weeks before the first dose of study drug; Signs of pulmonary infection or active pulmonary inflammation within 4 weeks;\n20. Participated in another clinical trial within 4 weeks before the first dose;\n21. Patients with superior vena cava syndrome should not be rehydrated;\n22. Have a history of psychotropic substance abuse with an inability to quit or a history of severe neurological or psychiatric illness;\n23. Imaging examination showed that the tumor had invaded or wrapped the large thoracic vessels;\n24. Serious unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent;\n25. Clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;\n26. Subjects who are scheduled to receive live vaccine or receive live vaccine within 28 days before the first dose;\n27. Other circumstances considered by the investigator to be inappropriate for participation in the trial.",{"count":696,"type":21},52,[96],"This phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 combined with PD-1 monoclonal antibody in patients with unresectable locally advanced or recurrent metastatic triple-negative breast cancer.",[183],"2026-07-22",{"date":678,"type":32},{"date":703,"type":32},"2024-08-02",{"date":705,"type":21},"2028-06",{"name":707,"class":39},"Sichuan Baili Pharmaceutical Co., Ltd.",{"id":709,"slug":710,"hasResults":12,"nctId":711,"briefTitle":712,"officialTitle":713,"acronym":714,"eligibilityCriteria":715,"healthyVolunteers":12,"sex":207,"minAge":18,"maxAge":4,"enrollmentInfo":716,"targetDuration":4,"studyType":22,"phases":718,"briefSummary":720,"conditions":721,"keywords":722,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":700,"lastUpdatePostDateStruct":726,"startDateStruct":727,"completionDateStruct":729,"leadSponsor":731,"locationsCount":111},"100533414","early-detection-of-triple-negative-breast-cancer-relapse-cupcake-100533414","NCT06225505","Early Detection of Triple Negative Breast Cancer Relapse (CUPCAKE)","Early Detection of Triple Negative Breast Cancer Relapse: a Clinical Utility Phase II Trial","CUPCAKE","Inclusion Criteria:\n\n1. Patients must have signed a written informed consent before inclusion\n2. Patients must be female ≥ 18 years old\n3. Patients diagnosed with a non-metastatic TNBC (ER \\& PR \\\u003C10%, HER2- per ASCO\u002FCAP guidelines). Patients must have been previously evaluated by a 18F-FDG PET-CT or a bone scintigraphy combined with a thorax, abdomen and pelvis CT scan with contrast\n4. Patients who have undergone surgery with curative intent for their non-metastatic TNBC. Surgery must have been performed between 3 to 24 months before inclusion. Patients must have initiated their adjuvant therapy, whenever indicated, since at least 12 weeks. For patients receiving an experimental adjuvant treatment in a clinical trial, any intervention planned as part of this trial must be completed before inclusion.\n5. High-risk primary tumor, defined as:\n\n   1. Lack of pathological complete response after neoadjuvant chemotherapy (RCB I, II or III; RCB I being capped to a maximum of 30% of included patients) OR, in the absence of neoadjuvant chemotherapy,\n   2. Stage IIB-III (i.e., T2N1, any T3-T4, any N2-3) OR\n   3. Any loco-regional relapse occurring after a prior ipsilateral, curatively treated TNBC\n6. No sign of local or distant relapse, as per investigator assessment\n7. Performance status \\\u003C 2\n8. Available FFPE tumor block with \\> 10% cellularity or 11 tumor sections with \\>10% cellularity\n9. Patient able to comply with protocol requirements\n10. Patients covered by a health insurance\n\nExclusion Criteria:\n\n1. Any uncontrolled disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding or any other medical condition that, in the opinion of the investigator, interferes with the trial procedures\n2. Male participants\n3. Patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent.\n4. Patients who have difficulty undergoing trial procedures for geographic, social or psychological reasons\n5. Person deprived of liberty or under guardianship\n6. History of another primary malignancy except for the following :\n\n   1. Basal cell carcinoma or any in situ carcinoma treated with curative intent\n   2. Any stage I-II malignancy treated with curative intent with no evidence of active disease in the last five years\n7. For step #2 (randomization after ctDNA detection): clinical\u002Fradiological metastatic relapse before the detection of the molecular relapse.",{"count":717,"type":21},450,[719],"NA","CUPCAKE is a randomized, non-comparative, multicenter, proof-of-concept phase II trial, using the Trials within Cohorts concept(1) to assess the clinical utility of ctDNA monitoring combined with 68Ga-FAPI-46-PET-CT imaging upon ctDNA detection for the surveillance of patients with a non-metastatic TNBC at high risk of relapse.\n\nThe study has two steps. In Step 1, patients who have completed the treatments for a localized TNBC will undergo ctDNA monitoring every \\~4 months (± 2 weeks). In Step 2, patients for whom ctDNA will be detected will then be randomized between an observation arm, in which monitoring will continue until the detection of a clinical relapse, and an experimental arm, in which the ctDNA detection will be revealed to both the patient and the clinician: patients will then undergo a 18F-FDG PET-CT and a 68Ga-FAPI-46-PET-CT, in addition to whatever workup the investigator will deem necessary.",[64],[723,724,725],"Triple negative breast cancer","68Ga-FAPI-46","ctDNA",{"date":678,"type":32},{"date":728,"type":32},"2026-01-05",{"date":730,"type":21},"2031-08-03",{"name":732,"class":169},"Institut Curie",{"id":734,"slug":735,"hasResults":12,"nctId":736,"briefTitle":737,"officialTitle":738,"acronym":4,"eligibilityCriteria":739,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":740,"targetDuration":4,"studyType":22,"phases":742,"briefSummary":743,"conditions":744,"keywords":748,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":752,"lastUpdatePostDateStruct":753,"startDateStruct":754,"completionDateStruct":756,"leadSponsor":758,"locationsCount":111},"100617452","phase-1-a-study-to-learn-about-the-study-medicine-called-pf-08032562-in-people-with-advanced-or-metastatic-solid-tumors-100617452","NCT07318805","A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors","A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-08032562 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS","Inclusion Criteria:\n\n* 18 years of age or older\n* Advanced or metastatic cancer of the breast or colon Part 1A: metastatic or advanced breast cancer or colorectal cancer for which no standard therapy is available Part 1B: metastatic or advanced breast cancer with disease progression after at least 1 line of treatment with an endocrine therapy and CDK4\u002F6 inhibitor in the advanced or metastatic setting Part 1C: metastatic or advanced colorectal cancer with at least having received chemotherapy and\u002For targeted therapy if appropriate Part 1D: metastatic or advanced colorectal cancer without any prior chemotherapy for advanced or metastatic disease Part 2A: metastatic or advanced breast cancer with disease progression after at least 1 prior line of CDK4\u002F6 inhibitor and at least 1 prior line of endocrine therapy Part 2B: metastatic or advanced colorectal cancer with at least having received chemotherapy and\u002For targeted therapy if appropriate Part 2C: metastatic or advanced colorectal cancer without any prior chemotherapy for advanced or metastatic disease\n* Measurable disease\n* ECOG performance status 0 or 1\n\nExclusion Criteria:\n\n* Active malignancy within 3 years prior to enrollment\n* Known symptomatic brain metastases requiring steroids\n* Advanced\u002Fmetastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term\n* Prior irradiation to \\>25% of the bone marrow\n* Hypertension that cannot be controlled by optimal medical therapy\n* Renal impairment\n* Hepatic dysfunction\n* Cardiac abnormalities\n* Active bleeding disorder\n* Active or history of clinically significant GI disease\n* Other unacceptable abnormalities as defined by protocol",{"count":741,"type":21},260,[52],"The purpose of this study is to learn about the safety and effects of the study medicine when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment to stop the growth of cancer. This study also aims to find the best amount of study medication.\n\nThis study is seeking participants that have advanced or metastatic breast cancer (BC), or advanced or metastatic colorectal cancer (CRC).\n\nAll participants in this study will take the study medication (PF-08032562) as pill by mouth. This will be repeated for 28-day cycles.\n\nDepending on which part of the study participants are enrolled into, they will receive the study medication PF-08032562 alone or in combination with other anti-cancer medications. The study medication (PF-08032562) will be taken by mouth (PO) in combination with other anti-cancer medications given in the study clinic by intramuscular (IM) injection into the muscle or intravenous (IV) infusion that is directly injected into the veins at different times (depending on the treatment) during the 28-day cycle. The study may also test different schedules.",[745,746,58,747,64],"Advanced Breast Cancer","Metastatic Breast Cancer (HR+\u002F HER2-)","Metastatic Colorectal Adenocarcinoma",[749,750,328,64,751],"Carcinoma, Breast","Estrogen Receptor Positive Breast Cancer","Colon Cancer","2026-07-21",{"date":700,"type":32},{"date":755,"type":32},"2025-12-23",{"date":757,"type":21},"2030-04-14",{"name":759,"class":39},"Pfizer"]