[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Seagen, a wholly owned subsidiary of Pfizer\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":209},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,45,95,124,151,185],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100458748","phase-3-a-study-of-tucatinib-with-trastuzumab-and-mfolfox6-versus-standard-of-care-treatment-in-first-line-her2-metastatic-colorectal-cancer-100458748",false,"NCT05253651","A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer","An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer","MOUNTAINEER-03","Inclusion Criteria:\n\n* Histologically and\u002For cytologically confirmed adenocarcinoma of the colon or rectum which is locally advanced unresectable or metastatic\n* Able to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks (or freshly sectioned slides) obtained prior to treatment initiation to a central laboratory\n\n  * If archival tissue is not available, a newly-obtained baseline biopsy of an accessible tumor lesion is required within 35 days prior to start of study treatment\n* HER2+ disease as determined by a tissue based assay performed at a central laboratory.\n* Participant has rat sarcoma viral oncogene homolog wild-type (RAS WT) disease as determined by local or central testing. For central RAS analysis, tissue sample must be analyzed within 1 year of biopsy date.\n* Radiographically measurable disease per RECIST v1.1 with:\n\n  * At least one site of disease that is measurable and that has not been previously irradiated, or\n  * If the participant has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* CNS Inclusion - based on contrast brain magnetic resonance imaging, participants may have any of the following:\n\n  * No evidence of brain metastases\n  * Previously treated brain metastases which are asymptomatic\n\nExclusion Criteria:\n\n* Prior systemic anticancer therapy for colorectal cancer (CRC) in the locally advanced unresectable or metastatic setting; note that participants may have received a maximum of 2 doses of mFOLFOX6 in the locally advanced\u002Funresectable or metastatic setting prior to randomization.\n\n  * Note: May have received chemotherapy for CRC in the adjuvant setting if it was completed \\>6 months prior to enrollment\n* Radiation therapy within 14 days prior to enrollment (or within 7 days in the setting of stereotactic radiosurgery)\n* Previous treatment with anti-HER2 therapy\n* Ongoing Grade 3 or higher neuropathy\n* Active or untreated gastrointestinal (GI) perforation at the time of screening.","ALL","18 Years",{"count":20,"type":21},400,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also determine what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease.\n\nParticipants in this study have colorectal cancer that has spread through the body (metastatic) and\u002For cannot be removed with surgery (unresectable).\n\nParticipants will be assigned randomly to the tucatinib group or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either:\n\n* mFOLFOX6 alone,\n* mFOLFOX6 with bevacizumab, or\n* mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer.",[27],"Colorectal Neoplasms",[29,30,31],"Colorectal Cancer","CRC","Seattle Genetics","RECRUITING","2026-06-02",{"date":35,"type":36},"2026-06-04","ACTUAL",{"date":38,"type":36},"2022-10-24",{"date":40,"type":21},"2030-07-03",{"name":42,"class":43},"Seagen, a wholly owned subsidiary of Pfizer","INDUSTRY",381,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":70,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},"100392410","phase-1-a-study-of-sigvotatug-vedotin-in-advanced-solid-tumors-100392410","NCT04389632","A Study of Sigvotatug Vedotin in Advanced Solid Tumors","A Phase 1 Study of Sigvotatug Vedotin in Advanced Solid Tumors","Inclusion Criteria:\n\n* Disease indication\n\n  * Participants must have histologically or cytologically confirmed metastatic or unresectable solid malignancy within one of the tumor types listed below (dependent on study part).\n\n    * Non-small cell lung cancer (NSCLC)\n    * Head and neck squamous cell cancer (HNSCC)\n    * Advanced HER2-negative breast cancer\n    * Esophageal squamous cell carcinoma (ESCC)\n    * Esophageal\u002FGastro-esophageal junction adenocarcinoma (EAC\u002FGEJ)\n    * Cutaneous squamous cell cancer (cSCC)\n    * Exocrine pancreatic adenocarcinoma\n    * Bladder cancer\n    * Cervical cancer\n    * Gastric cancer\n    * High grade serous ovarian cancer (HGSOC)\n  * Part A only: Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies and should have no appropriate standard-of-care therapeutic options.\n  * Part B only: Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies. Participants must have received platinum-based therapy and a PD-1\u002FPD-(L)1 inhibitor, if applicable and available.\n  * Part C only: For pembrolizumab combination cohorts, participants must be eligible for pembrolizumab per local standard of care. For pembrolizumab with cisplatin or carboplatin, participants must be eligible for both pembrolizumab and the platinum agent per local standard of care. Participants must be treatment naïve for locally advanced or metastatic systemic therapy (prior definitively intended or \\[neo\\]adjuvant therapy is allowed).\n  * Part D only: Participants must be treatment naïve for locally advanced or metastatic systemic therapy.\n* Participants enrolled in the following study parts should have a tumor site accessible for biopsy and agree to biopsy as follows:\n\n  * Disease-specific expansion cohorts (Part B and Part D): A baseline fresh tumor biopsy is required. An archival biopsy collected within 90 days prior to first dose of study drug may be used.\n  * Biology expansion cohort: pretreatment biopsy and on-treatment (Cycle 1) biopsy\n* An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Measurable disease per the RECIST v1.1 at baseline\n\nExclusion Criteria\n\n* History of another malignancy within 3 years before first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.\n* Known active central nervous system metastases. Participants with previously treated brain metastases may participate provided they:\n\n  * are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment,\n  * have no new or enlarging brain metastases, and\n  * are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to first dose of study drug.\n  * In Part D, participants with untreated, asymptomatic CNS metastases smaller than 1 cm may be enrolled without definitive treatment as long as they have no neurological symptoms, no or minimal surrounding edema, and no requirements for corticosteroids.\n* Carcinomatous meningitis\n* Previous receipt of an MMAE-containing agent or an agent targeting integrin beta-6\n* Pre-existing neuropathy Grade 1 or greater per the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) for Parts C and D cohorts with cisplatin or carboplatin; Grade 2 or greater per the NCI CTCAE v5.0 for all other cohorts\n* Any uncontrolled Grade 3 or higher (per NCI CTCAE v5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of sigvotatug vedotin.\n\n  * Routine antimicrobial prophylaxis is permitted\n* Grade ≥3 pulmonary disease unrelated to underlying malignancy. This includes clinically severe pulmonary function compromise resulting from clinically significant pulmonary illnesses\n* Part C and D: Prior therapy with a PD-1 inhibitor, anti-PD-(L)1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and was discontinued from that treatment due to a Grade 3 or higher immune-mediated adverse event (IMAE).\n* History of noninfectious interstitial lung disease (ILD) or pneumonitis that required steroids, current ILD or pneumonitis, or suspected ILD or pneumonitis that cannot be ruled out by imaging at screening\n* Known diffusing capacity of the lung for carbon monoxide (DLCO; adjusted for hemoglobin) \\\u003C50% predicted\n* Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.",{"count":53,"type":21},1006,[55],"PHASE1","This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors. It will study sigvotatug vedotin to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether sigvotatug vedotin works to treat solid tumors.\n\nThe study will have four parts.\n\n* Part A of the study will find out how much sigvotatug vedotin should be given to participants.\n* Part B will use the dose found in Part A to find out how safe sigvotatug vedotin is and if it works to treat solid tumors.\n* Part C of the study will find out how safe sigvotatug vedotin is in combination with these other drugs.\n* Part D will include people who have not received treatment. This part of the study will find out how safe sigvotatug vedotin is in combination with these other drugs and if these combinations work to treat solid tumors.\n* In Parts C and D, participants will receive sigvotatug vedotin with either:\n\n  * Pembrolizumab or,\n  * Pembrolizumab and carboplatin, or\n  * Pembrolizumab and cisplatin.",[58,59,60,61,62,63,64,65,66,67,68,69],"Carcinoma, Non-Small Cell Lung","Squamous Cell Carcinoma of Head and Neck","HER2 Negative Breast Neoplasms","Esophageal Squamous Cell Carcinoma","Esophageal Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma","Ovarian Neoplasms","Cutaneous Squamous Cell Cancer","Exocrine Pancreatic Adenocarcinoma","Urinary Bladder Neoplasms","Uterine Cervical Neoplasms","Stomach Neoplasms",[71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,31],"NSCLC","HNSCC","cSCC","ESCC","EAC","GEJ","HGSOC","Advanced HER2-Negative Breast Cancer","High Grade Serous Ovarian Cancer","Non-Small Cell Lung Cancer","Head and Neck Squamous Cell Cancer","Esophageal Cancer","Bladder Cancer","Cervical Cancer","Gastric Cancer","2026-05-08",{"date":88,"type":36},"2026-05-11",{"date":90,"type":36},"2020-06-08",{"date":92,"type":21},"2029-03-22",{"name":42,"class":43},159,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},"100429996","phase-2-a-study-of-disitamab-vedotin-alone-or-with-pembrolizumab-in-urothelial-cancer-that-expresses-her2-100429996","NCT04879329","A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2","A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) Alone or in Combination With Pembrolizumab in Subjects With Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2","Inclusion Criteria:\n\nCohorts A and B\n\n* Histopathologically-confirmed, locally-advanced, unresectable or metastatic urothelial cancer (LA\u002FmUC), including UC originating from the renal pelvis, ureters, bladder, or urethra\n* Participants must have received only 1 or 2 lines of prior systemic treatment for LA\u002FmUC, including 1 line of platinum-containing chemotherapy\n* At least one measurable lesion by investigator assessment based on RECIST version 1.1.\n* HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n\nCohort C\n\n* Histopathologically-confirmed LA\u002FmUC, including UC originating from the renal pelvis, ureters, bladder, or urethra\n* No prior systemic therapy for LA\u002FmUC\n\n  * Neoadjuvant or adjuvant therapy, including PD-(L)1 inhibitors, is acceptable, if disease recurrence\u002Fprogression occurred more than 12 months after the last dose of systemic therapy\n* At least one measurable lesion by investigator assessment based on RECIST v1.1.\n* Participant is eligible to receive cisplatin- or carboplatin- containing chemotherapy per investigator evaluation\n* HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, on the provided tumor tissue sample\n* ECOG performance status of 0, 1, or 2\n\nCohort D\n\n* Histopathologically-confirmed LA\u002FmUC, including UC originating from the renal pelvis, ureters, bladder, or urethra\n* Based on a participant's eligibility to receive treatment with standard of care therapies in Japan, participants must have received all of the following lines of therapy for LA\u002FmUC:\n\n  * a. One prior line of platinum-containing chemotherapy.\n  * b. Prior therapy with PD-(L)1 inhibitors as (neo)adjuvant therapy, first-line maintenance therapy or as second line treatment.\n  * c. Prior enfortumab vedotin therapy.\n* At least one measurable lesion by investigator assessment based on RECIST v1.1.\n* ECOG performance status of 0 or 1\n\nCohort E\n\n* Histopathologically-confirmed LA\u002FmUC, including UC originating from the renal pelvis, ureters, bladder, or urethra\n* No prior systemic therapy for LA\u002FmUC\n\n  * Neoadjuvant or adjuvant therapy, including PD-(L)1 inhibitors, is acceptable, if disease recurrence\u002Fprogression occurred more than 12 months after the last dose of systemic therapy.\n* At least one measurable lesion by investigator assessment based on RECIST v1.1.\n* Participant is eligible to receive cisplatin- or carboplatin- containing chemotherapy per investigator evaluation\n* HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample\n* ECOG performance status of 0 or 1\n\nCohort G\n\n* Histopathologically-confirmed, locally-advanced, unresectable or metastatic urothelial cancer (LA\u002FmUC), including UC originating from the renal pelvis, ureters, bladder, or urethra\n* Participants must have received only 1 or 2 lines of prior systemic treatment for LA\u002FmUC, including 1 line of therapy containing enfortumab vedotin as monotherapy or in combination with pembrolizumab\n\n  * The last administration of enfortumab vedotin must be 90 days from the start of study treatment. Intervening therapies are allowed between the final dose of enfortumab vedotin and the start of disitamab vedotin.\n* At least one measurable lesion by investigator assessment based on RECIST version 1.1.\n* HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n\nExclusion Criteria:\n\nCohorts A and B\n\n* Known hypersensitivity to disitamab vedotin or any of their components\n* Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohorts A and B)\n* Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)\n* Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy\n* Major surgery that has not fully recovered within 4 weeks prior to dose administration\n* Peripheral sensory or motor neuropathy ≥ Grade 2 at baseline\n\nCohort C\n\n* Known hypersensitivity to disitamab vedotin, pembrolizumab, or any of their components\n* Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study defined as Cycle 1 Day 1 for the single-arm part of Cohort C and as randomization date for the randomized part of Cohort C)\n* Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)\n* Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy\n* Major surgery that has not fully recovered within 4 weeks prior to dose administration\n* Peripheral sensory or motor neuropathy ≥ Grade 2 at baseline\n* 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 therapy within 7 days prior the first dose of study drug\n* Participants who have previously received any prior treatment with an agent directed to another stimulatory or co-inhibitory T cell receptor (including but not limited to CD137 agonists, CAR-T cell therapy, CTLA-4 inhibitors, or OX-40 agonists) are excluded.\n\nCohort D\n\n* Known hypersensitivity to disitamab vedotin or any of their components\n* Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohort D)\n* Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)\n* Prior HER2-directed therapy\n* Any prior history of ≥ Grade 3 non-hematological AEs related to prior therapy\n* Major surgery that has not fully recovered within 4 weeks prior to dose administration\n* Peripheral sensory or motor neuropathy ≥ Grade 1 at baseline\n\nCohort E\n\n* Known hypersensitivity to disitamab vedotin, pembrolizumab, or any of their components\n* Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohort E)\n* Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)\n* Any prior history of ≥ Grade 3 non-hematological AEs related to prior therapy\n* Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy\n* Major surgery that has not fully recovered within 4 weeks prior to dose administration\n* Peripheral sensory or motor neuropathy ≥ Grade 1 at baseline\n* 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 therapy within 7 days prior the first dose of study drug\n\nCohort G\n\n* Known hypersensitivity to disitamab vedotin or any of their components\n* Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohort G)\n* Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)\n* Prior HER2-directed therapy\n* Major surgery that has not fully recovered within 4 weeks prior to dose administration\n* Peripheral sensory or motor neuropathy ≥ Grade 2 at baseline\n\nThere are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.",{"count":103,"type":21},372,[105],"PHASE2","This study is being done to see if a drug called disitamab vedotin, alone or with pembrolizumab, works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants.\n\nParticipants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).\n\nIt will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.",[108],"Urothelial Carcinoma",[110,83,111,112,113,114,31],"Urothelial Cancer","HER2 Mutations","HER2 Overexpression","HER2 Amplification","RC48","2026-04-20",{"date":117,"type":36},"2026-04-21",{"date":119,"type":36},"2022-05-03",{"date":121,"type":21},"2029-04-14",{"name":42,"class":43},223,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":139,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},"100526215","phase-1-a-study-of-sgn-ceacam5c-in-adults-with-advanced-solid-tumors-100526215","NCT06131840","A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors","An Open-label Phase 1 Study to Investigate PF-08046050 (SGN-CEACAM5C) in Adults With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Tumor type:\n\n   * Participants in Part A (dose escalation) and Part B (dose optimization) must have histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancy. Must have relapsed, refractory, or progressive disease, and should have no appropriate standard therapy available.\n\n     * Participants in Part A must have one of the following tumor types: colorectal cancer (CRC); gastric carcinoma (GC) or gastroesophageal junction adenocarcinoma (GEJ); non-small cell lung cancer (NSCLC); or pancreatic ductal adenocarcinoma (PDAC).\n     * The tumor types to be enrolled in Part B will be identified by the sponsor from among those specified in Part A.\n   * Participants in Part C (dose expansion) must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancies.\n\n     * CRC (adenocarcinoma of the colon or rectum) and must have received no more than 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and evidence of either progressive disease or intolerance to their last regimen.\n     * PDAC with one or more metastatic lesions measurable by computed tomography\u002Fmagnetic resonance imaging according to RECIST v1.1 criteria; and must have received no more than 1 prior chemotherapy regimen for the treatment of advanced PDAC and evidence of either progressive disease or intolerance to that regimen.\n     * GC or GEJ and must have received prior platinum and fluoropyrimidine-based chemotherapy.\n     * NSCLC and must have received platinum-based therapy. If eligible and consistent with local standard of care must have received a PD-1\u002FPD-L1 inhibitor. In addition, participants with tumor genomic mutations\u002Falterations for which approved targeted therapies are available per local standard of care, must have received such therapies.\n     * Small cell lung cancer (SCLC) and must have received platinum-based therapy for extensive-stage disease and no more than 3 prior lines of therapy. If eligible and consistent with local standard of care must have received a PD 1\u002FPD-L1 inhibitor.\n   * CRC participants in Part D and Part E (bevacizumab combination therapy) must have histologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Received a maximum of 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen.\n   * CRC participants in Part D and Part E (5FU\u002FLV + bevacizumab and 5FU\u002FLV + oxaliplatin + bevacizumab combination therapy) must have histologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Must not have received a prior TOPO1 inhibitor (such as irinotecan or nanoliposomal irinotecan) in any setting. 1L cohorts: No prior chemotherapy for advanced disease. 2L cohorts (applicable to 5FU\u002FLV + bevacizumab combination only): 1 prior chemotherapy regimen for the treatment of advanced disease, which must have included a fluoropyrimidine and oxaliplatin.\n\n   \\> 2L PDAC participants in Part E (5FU\u002FLV combination therapy) must have histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma. One or more metastatic lesions measurable by computed tomography\u002Fmagnetic resonance imaging according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.\n\n   \\> 1L PDAC participants in Part E (5FU\u002FLV + oxaliplatin combination therapy) must have histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma that has not been previously treated in the metastatic setting. One or more metastatic lesions measurable by computed tomography\u002Fmagnetic resonance imaging according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. No prior chemotherapy for PDAC with the following exception: Patients who received adjuvant\u002Fneoadjuvant chemotherapy and who had recurrence more than 12 months after completion of adjuvant\u002Fneoadjuvant chemotherapy are eligible.\n2. Participants enrolled in the following study parts should have a tumor site that is accessible for biopsy(ies) and agree to biopsy(ies) and\u002For submission of archival tissue:\n\n   * Monotherapy dose optimization (Part B)\n   * Monotherapy (Part C) and combination therapy (Part E) disease-specific expansion cohorts\n3. An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1\n4. Measurable disease per Response Evaluation in Solid Tumors (RECIST) v1.1 at baseline.\n\nExclusion Criteria:\n\n1. Previous exposure to CEACAM5-targeted therapy.\n2. Prior treatment with a TOPO1-targeting ADC (CPT payload), such as Enhertu (trastuzumab deruxtecan) or Trodelvy (sacituzumab govitecan).\n3. History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.\n4. Active cerebral\u002Fmeningeal disease related to the underlying malignancy. Participants with a history of cerebral\u002Fmeningeal disease related to the underlying malignancy are allowed if prior central nervous system disease has been treated and the participant is clinically stable (defined as not having received steroid treatment for symptoms related to cerebral\u002Fmeningeal disease for at least 2 weeks prior to enrollment and with no ongoing related AEs).\n\n   \\> Criteria related to bevacizumab administration (participants in Parts D and E)\n5. History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients.\n6. History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.\n7. Serious non-healing wound, non-healing ulcer, or non-healing bone fracture.\n8. Deep venous thromboembolic event within 4 weeks prior to enrollment\n9. Known coagulopathy that increases risk of bleeding, bleeding diatheses.\n10. History of any life-threatening VEGF-related adverse event",{"count":132,"type":21},914,[55],"This clinical trial is studying advanced solid tumors. Solid tumors are cancers that start in a part of your body like your lungs or liver instead of your blood. Once tumors have grown bigger in one place but haven't spread, they're called locally advanced. If your cancer has spread to other parts of your body, it's called metastatic. When a cancer has gotten so big it can't easily be removed or has spread to other parts of the body, it is called unresectable. These types of cancer are harder to treat.\n\nParticipants in this study must have cancer that has come back or did not get better with treatment. Participants must have a solid tumor cancer that can't be treated with standard of care drugs.\n\nThis clinical trial uses an experimental drug called PF-08046050. PF-08046050 is a type of antibody-drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. They may also stick to some normal cells.\n\nThis study will test the safety of PF-08046050 in participants with solid tumors that are hard to treat or have spread throughout the body.\n\nThis study has 5 different study parts. Part A and Part B of the study will find out how much PF-08046050 should be given to participants. Part C will use the information from Parts A and B to see if PF-08046050 is safe and if it works to treat certain solid tumor cancers. Part D and E of the study, together with information from Parts A and B, will find out how much PF-08046050 should be given in combination with other anti-cancer agents. Part E will use the information from Parts A, B, and D to see if PF-08046050 is safe in combination with other anti-cancer agents and if it works to treat a certain solid tumor.",[27,136,69,137,63,138],"Carcinoma, Non-Small-Cell Lung","Pancreatic Ductal Adenocarcinoma","Small Cell Lung Carcinoma",[30,71,140,141,76,142,31],"PDAC","GC","SCLC","2026-04-17",{"date":115,"type":36},{"date":146,"type":36},"2023-11-20",{"date":148,"type":21},"2030-09-12",{"name":42,"class":43},44,{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":160,"briefSummary":161,"conditions":162,"keywords":168,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":178,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":184},"100455301","phase-1-a-study-of-pf-08046054sgn-pdl1v-in-advanced-solid-tumors-100455301","NCT05208762","A Study of PF-08046054\u002FSGN-PDL1V in Advanced Solid Tumors","A Phase 1 Study of PF-08046054\u002FSGN-PDL1V in Advanced Solid Tumors","Inclusion Criteria:\n\n* Parts A and B:\n\n  * Participants must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor types\n\n    * Non-small cell lung cancer (NSCLC)\n    * Head and neck squamous cell carcinoma (HNSCC) (except nasopharyngeal cancer)\n    * Esophageal squamous cell carcinoma (SCC)\n    * Triple negative breast cancer (TNBC)\n  * Participants must have disease that is relapsed or refractory, that has progressed on approved therapies, be intolerant to or refused such therapies, or such and therapies are contraindicated and in the judgement of the investigator, should have no appropriate SoC therapeutic option\n  * Participants must have PD-L1 expression based on historical testing\n* Part C:\n\n  * Participants must have disease that is relapsed or refractory or be intolerant to SoC therapies and must have one of the following tumor types\n\n    * HNSCC\n\n      * Participants with HNSCC must have histologically or cytologically-confirmed HNSCC\n    * NSCLC\n\n      * Participants must have histologically or cytologically-confirmed NSCLC. Participants with SCC and non--SCC histology are eligible. Note: Participants with a neuroendocrine component or histology are not eligible.\n    * Esophageal SCC\n    * Pancreatic cancer\n    * Hepatocellular carcinoma\n    * TNBC\n    * Gastric cancer\n    * Endometrial cancer\n  * Participants must have been previously tested for PD-L1 expression and should have PD-L1 expression ≥1 or \\\u003C1 by CPS or TPS based on historical testing\n* Part D and Part E:\n\n  * Participants must have histologically or cytologically-confirmed disease of the HNSCC or NSCLC\n  * Participants must have PD-L1 expression based on historical testing\n  * Participants with NSCLC; PD-L1 expression ≥ 1% by TPS\n  * Participants with HNSCC; PD--L1 expression ≥1 by CPS\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* Measurable disease per RECIST v1.1 at baseline\n\nExclusion Criteria:\n\n* History of another malignancy within 3 years of first dose of study treatment or any evidence of residual disease from a previously diagnosed malignancy.\n* Known active central nervous system metastases. Participants with previously-treated brain metastases may participate provided they:\n\n  * Are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment\n  * Have no new or enlarging brain metastases\n  * And are off of corticosteroids prescribed for symptoms associate with brain metastases for at least 7 days prior to first dose of study treatment\n* Lepto-meningeal disease\n* Prior treatment with an anti-PD-L1 agent within less than 5 half-lives. This duration of time will vary according to the half-life of the specific agent.\n* Previous receipt of an monomethylauristatin E (MMAE)-containing agent.\n* Pre-existing neuropathy ≥Grade 2 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.\n\nThere are additional inclusion criteria. The study center will determine if criteria for participations are met.",{"count":159,"type":21},714,[55],"This study will test the safety of a drug called PF-08046054\u002FSGN-PDL1V alone and with pembrolizumab in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease.\n\nParticipants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).\n\nThis study will have five parts. Parts A and B of the study will find out how much PF-08046054\u002FSGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe PF-08046054\u002FSGN-PDL1V is and if it works to treat solid tumor cancers. In Part D and E, participants will be given PF-08046054\u002FSGN-PDL1V with pembrolizumab to find out how safe this combination is and if it works to treat solid tumor cancers.",[136,163,61,164,85,165,166,167],"Squamous Cell Carcinoma of the Head and Neck","Triple Negative Breast Neoplasms","Endometrial Cancer","Pancreatic Adenocarcinoma","Hepatocellular Carcinoma",[169,71,170,72,171,172,173,31,174,140,175,176,177],"Non-small cell lung cancer","Head and neck squamous cell carcinoma","Triple Negative Breast Cancer","TNBC","Gastric cancer","HCC","Esophageal","Pfizer","Endometrial",{"date":115,"type":36},{"date":180,"type":36},"2022-10-25",{"date":182,"type":21},"2029-01-04",{"name":42,"class":43},61,{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":22,"phases":194,"briefSummary":195,"conditions":196,"keywords":199,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":208},"100379997","phase-1-a-safety-study-of-sea-cd70-in-patients-with-myeloid-malignancies-100379997","NCT04227847","A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies","A Phase 1 Study of SEA-CD70 in Myeloid Malignancies","Part A Inclusion Criteria\n\n* Participants with cytologically\u002Fhistologically confirmed MDS (2016 World Health Organization (WHO) classification) with\n\n  * Measurable disease per WHO MDS with excess blasts criteria\n  * MDS that is relapsed or refractory and must not have other therapeutic options\n  * Treatment failure after prior hypomethylating agent (HMA) therapy for MDS\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n\nPart B Inclusion Criteria\n\n* Participants with cytologically\u002Fhistologically confirmed MDS (WHO classification) with:\n\n  * Measurable disease per WHO MDS with excess blasts (MDS-EB) criteria\n  * MDS that is relapsed or refractory and must not have other therapeutic options\n  * Treatment failure after prior HMA therapy for MDS\n* ECOG Performance Status of 0-2\n\nPart C Inclusion Criteria\n\n* Participants with relapsed or refractory AML (ICC 2022) (except for acute promyelocytic leukemia \\[APL\\]):\n\n  * Who have received either 2 or 3 previous regimens\n  * Who have received 1 previous regimen to treat active disease and have at least one of the following:\n\n    * Age \\> 60 and ≤75 years.\n    * Primary resistant AML or secondary AML\n    * First CR duration \\\u003C6 months\n    * Adverse-risk per European Leukemia Network genetic risk stratification\n* Age 18-75 years\n* ECOG performance status of 0-2\n\nParts D and F Inclusion Criteria\n\n* Participants with diagnosis of MDS or MDS\u002FAML (ICC 2022 criteria)\n* Disease which has relapsed, failed to respond after minimum of 6 cycles, or progressed following an HMA in the immediately preceding line of therapy.\n* Eligible for continued therapy with azacitidine\n* ECOG Performance Status 0-2\n\nParts D and E Inclusion Criteria\n\n* Participants with diagnosis of MDS or MDS\u002FAML (ICC 2022 criteria), previously untreated.\n* Participants with higher-risk per IPSS-M MDS and MDS\u002FAML\n* ECOG Performance Status 0-2\n\nPart G Inclusion Criteria\n\n* Participants with diagnosis of AML (ICC 2022 criteria), previously untreated and ineligible for standard induction chemotherapy.\n* Age ≥18 years.\n* ECOG Performance Status of 0-2.\n\nExclusion Criteria (All Parts)\n\n* Previous exposure to CD70-targeted agents\n* Prior allogeneic hematopoietic stem cell transplant, for any condition\n* Central nervous system leukemia\n* History of clinically significant sickle cell anemia, autoimmune hemolytic anemia, or idiopathic thrombocytopenic purpura\n* Parts D, F and G only: Prior oral HMA or oral HMA-combinations\n* Part G: conditions that preclude enteral route of administration; concomitant use of strong\u002Fmoderate CYP3A inducers; history of myeloproliferative neoplasm",{"count":193,"type":21},178,[55],"This trial will look at a drug called SEA-CD70 with and without azacitidine, to find out if it is safe for participants with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). It will study SEA-CD70 to find out what its side effects are and if it works for AML and MDS. A side effect is anything the drug does besides treating cancer.\n\nThis study will have seven groups or \"parts.\"\n\n* Part A will find out how much SEA-CD70 should be given to participants\n* Part B will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat participants with MDS.\n* Part C will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat participants with AML.\n* Part D will find out how much SEA-CD70 with azacitidine should be given to participants\n* Part E will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat participants with MDS or MDS\u002FAML that has not been treated.\n* Part F will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat participants with MDS or MDS\u002FAML.\n* Part G will find out how much SEA-CD70 with azacitidine and with venetoclax should be given to participants with AML. Also, to evaluate safety and tolerability of PF-08046040 in combination with azacitidine and venetoclax in participants with previously untreated AML who are unfit for standard induction chemotherapy.",[197,198],"Myelodysplastic Syndrome","Acute Myeloid Leukemia",[31],"2026-04-06",{"date":202,"type":36},"2026-04-07",{"date":204,"type":36},"2020-08-07",{"date":206,"type":21},"2028-07-03",{"name":42,"class":43},54,""]