[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Coherus Oncology, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":146},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,56,85,119],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100566589","phase-1-a-study-of-chs-114-tagmokitug-in-combination-with-toripalimab-andor-other-treatments-in-participants-with-advanced-solid-tumors-100566589",false,"NCT06657144","A Study of CHS-114 (Tagmokitug) in Combination With Toripalimab and\u002For Other Treatments in Participants With Advanced Solid Tumors","A Phase 1B, Multicenter, Open-Label Study of the Safety and Efficacy of CHS-114 in Combination With Toripalimab With or Without Other Treatments in Participants With Advanced or Metastatic Solid Tumors (TREGCHECK 102)","Key Inclusion Criteria:\n\n* At least 1 measurable lesion based on RECIST v1.1 as determined by the Investigator.\n* Resolved acute effects of any prior therapy to baseline severity or Grade 1 in accordance with National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except for adverse events (AEs) not constituting a safety risk per Investigator judgement.\n\nCohort A (2L Gastric, Gastro-esophageal-junction \\[GEJ\\], Esophageal Adenocarcinoma \\[EAC\\]) Specific Inclusion Criteria:\n\n* Histologically or cytologically documented unresectable, locally advanced or metastatic gastric, GEJ, or esophageal adenocarcinoma that is human epidermal growth factor receptor 2 (HER2) - negative and microsatellite stable (MSS)\u002Fproficient mismatch repair (pMMR).\n* Progressed during or after first line systemic therapy that includes a platinum and fluoropyrimidine doublet with or without anti-programmed death receptor 1 (PD-1)\u002Fprogrammed death ligand 1 (PD-L1)-directed therapy (that is, in the second line setting).\n* Consent to provide tumor tissue samples (baseline and on-treatment) is required for enrollment.\n\nCohort B (2L Esophageal Squamous Cell Carcinoma \\[ESCC\\]) - Specific Inclusion Criteria:\n\n* Histologically or cytologically documented unresectable, locally advanced or metastatic ESCC.\n* Progressed during or after first line systemic therapy including a doublet of platinum and fluoropyrimidine or paclitaxel with or without anti-PD-1\u002FPD-L1-directed therapy or anti-CTLA-4 and anti-PD-1\u002FPD-L1-directed combination therapy.\n* Consent to provide results from prior PD-L1 IHC assay score by FDA-approved or equivalent PD-L1 IHC diagnostic tests.\n* Consent to provide archival tumor tissue sample (baseline) is required for enrolment.\n\nCohort C (1L Esophageal Squamous Cell Carcinoma \\[ESCC\\]) - Specific Inclusion Criteria:\n\n* Histologically or cytologically documented unresectable, locally advanced or metastatic ESCC.\n* Consent to provide baseline tumor tissue is required.\n* Consent to provide results from prior PD-L1 IHC assay score by FDA-approved or equivalent PD-L1 IHC diagnostic tests.\n* Calculated creatinine clearance ≥60 mL\u002Fmin.\n\nCohort D, Arms D1 and D2 (4L+ Colorectal Carcinoma \\[CRC\\]) - Specific Inclusion Criteria:\n\n* Histologically and\u002For cytologically documented unresectable advanced or metastatic colorectal adenocarcinoma. RAS, BRAF, and microsatellite instability\u002Fmismatch repair status for each participant must be documented, according to country level guidelines.\n* Participants who have no available therapies with a proven clinical benefit available in the participant's country per investigator. These therapies include the following: fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapy, anti-VEGF biological therapy (eg, bevacizumab, aflibercept, ramucirumab), an anti-EGFR therapy (eg, cetuximab, panitumumab) if RAS wildtype unless right-sided, either trifluridine\u002Ftipiracil, fruqintinib or regorafenib, and a BRAF inhibitor (ie, encorafenib) in BRAF V600E mutant).\n* Participants who received oxaliplatin in the adjuvant setting and developed metastatic disease during or within 6 months of completing adjuvant therapy are considered eligible without receiving oxalipatin-based therapy in the metastatic setting.\n* Consent to provide baseline tumor tissue sample is required for enrolment.\n\nKey Exclusion Criteria:\n\n* History of prior malignancy other than the cancer under study that is progressing or has required active treatment within the past 3 years.\n* Symptomatic or untreated central nervous system metastases, including leptomeningeal metastases, requiring concurrent treatment, including but not limited to surgery, radiation, and\u002For corticosteroids.\n* Major surgery requiring general anesthesia within 28 days prior to the first dose of study treatment, still recovering from prior surgery, or with surgery scheduled during the study.\n* Prior exposure to anti-C-C motif chemokine receptor 8 (CCR8) antibody.\n* History of Grade 4 allergic or anaphylactic reaction to any monoclonal antibody (mAb) therapy or any excipient in the study treatment.\n* Active uncontrolled bacterial, fungal, or viral infection including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.\n* Any condition that, in the opinion of the Investigator or Sponsor, would interfere with the interpretation of study results.\n\nCohort A (2L Gastric, Gastro-esophageal-junction \\[GEJ\\], Esophageal Adenocarcinoma \\[EAC\\]) Specific Exclusion Criteria:\n\n* Received ≥ 2 prior systemic anticancer therapies for advanced or metastatic disease.\n* Participants at high risk for developing esophageal fistula by clinical assessment or imaging, such as prior history or associated symptoms of esophageal fistula or T4 classification assessed by endoscopic ultrasound (EUS).\n\nCohort B (2L Esophageal Squamous Cell Carcinoma \\[ESCC\\]) - Specific Exclusion Criteria:\n\n* Received ≥ 2 prior systemic anticancer therapies for advanced or metastatic disease.\n* Participants at high risk for developing esophageal fistula by clinical assessment or imaging, such as prior history or associated symptoms of esophageal fistula or T4 classification assessed by endoscopic ultrasound (EUS).\n\nCohort C (1L Esophageal Squamous Cell Carcinoma \\[ESCC\\]) - Specific Exclusion Criteria:\n\n* Received ≥ 1 prior systemic anticancer therapies for advanced or metastatic disease.\n* Participants who progressed during or within 6 months following the last dose of neoadjuvant, or perioperative therapy with curative intent.\n* Participants at high risk for developing esophageal fistula by clinical assessment or imaging, such as prior history or associated symptoms of esophageal fistula or T4 classification assessed by endoscopic ultrasound (EUS).\n* Known dihydropyrimidine dehydrogenase deficiency or thymidine synthase gene polymorphism predisposing the participant to 5-FU toxicity.\n* Known allergies to 5-FU or cisplatin.\n\nNote: Other protocol-specified inclusion\u002Fexclusion criteria apply.","ALL","18 Years",{"count":19,"type":20},154,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The main purpose of this study is to evaluate the safety and preliminary efficacy of CHS-114 in combination with toripalimab and\u002For other standard of care (SOC) compound(s) in participants with advanced or metastatic solid tumors.",[26,27],"Metastatic Solid Tumor","Advanced Solid Tumor",[29,30,26,31,32,33,34,35,36,37,38,39,40,41,42],"Solid Tumors","Advanced Solid Tumors","Cancer","Oncology","Tumor","CCR8","PD-1","Gastric cancer","Gastro-esophageal-junction (GEJ) cancer","Esophageal Adenocarcinoma (EAC)","Esophageal Squamous Cell Carcinoma","Cisplatin","5 Fluorouracil (5-FU)","Colorectal Carcinoma (CRC)","RECRUITING","2026-06-10",{"date":46,"type":47},"2026-06-12","ACTUAL",{"date":49,"type":47},"2025-04-01",{"date":51,"type":20},"2028-01",{"name":53,"class":54},"Coherus Oncology, Inc.","INDUSTRY",30,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":16,"minAge":64,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":21,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100551239","phase-4-a-study-of-toripalimab-in-combination-with-cisplatin-and-gemcitabine-in-participants-with-recurrent-metastatic-nasopharyngeal-cancer-100551239","NCT06457503","A Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Participants With Recurrent Metastatic Nasopharyngeal Cancer","Single-Arm Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Recurrent Metastatic Nasopharyngeal Carcinoma Systemic Treatment Naïve Participants","TRANSPARENT","Key Inclusion Criteria:\n\n* Histological or cytological confirmation of recurrent\u002Fmetastatic nasopharyngeal cancer with either EBV or non-EBV-associated cancer. The following subgroups are included:\n\n  * EBER\u002FEBV-negative (HPV+\u002F-)\n  * EBER\u002FEBV-positive (HPV+\u002F-)\n* Recurrent\u002Fmetastatic (stage IV-B as defined by the International Union against Cancer \\[UICC\\] and American Joint Committee on Cancer \\[AJCC\\] staging system for nasopharyngeal cancer \\[NPC\\], eighth edition) or recurrent NPC after curative treatment. For recurrent NPC, more than 6 months between the last dose of radiotherapy or chemotherapy and the date of recurrence.\n* Measurable disease based on RECIST v 1.1 as determined by the site. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n\nKey Exclusion Criteria:\n\n* Disease that is suitable for local therapy administered with curative intent.\n* Prior systemic therapy administered in the recurrent or metastatic setting. Participants who develop disease recurrence within 6 months from curative intent chemoradiation will be excluded.\n* Rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain) in the opinion of the treating investigator.\n* Active or untreated central nervous system (CNS) metastases (e.g., brain or leptomeningeal), as determined on computerized tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments. Participants who have prior therapies for brain or leptomeningeal metastasis and have been stabilized ≥ 1 month and have discontinued systemic steroid therapy (\\>10 mg\u002Fday prednisone or equivalent) ≥ 1 month prior to enrollment are eligible.\n\nOther protocol-defined inclusion and exclusion criteria apply.","12 Years",{"count":66,"type":20},100,[68],"PHASE4","This study aims to investigate toripalimab with chemotherapy in participants with nasopharyngeal cancer.",[71],"Nasopharyngeal Cancer Recurrent",[73,74,75],"Programmed death 1 [PD1] inhibitor","Toripalimab","Recurrent metastatic nasopharyngeal cancer","2026-04-03",{"date":78,"type":47},"2026-04-06",{"date":80,"type":47},"2024-11-01",{"date":82,"type":20},"2027-12",{"name":53,"class":54},13,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":95,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},"100488094","phase-1-study-of-chs-114-in-participants-with-advanced-solid-tumors-100488094","NCT05635643","Study of CHS-114 in Participants With Advanced Solid Tumors","A Phase 1 Study of CHS-114 in Participants With Advanced Solid Tumors","Key Inclusion Criteria - Arms 1a, 1b, 2, and 3\n\n* Participants must be ≥ 18 years of age.\n* For Arm 1a only, locally advanced or metastatic (Stage IV) solid tumor that has progressed during or after standard therapy and for whom no available therapies are appropriate (based on the judgment of the Investigator).\n* At least 1 measurable lesion per RECIST 1.1.\n* Lesions previously treated with radiation or other forms of locoregional therapy must show radiographic evidence of disease progression to be used as a target lesion.\n* For Arms 1a, 1b, and 2 only, washout period from the last dose of previous anticancer therapy (chemotherapy, biologic, or other investigational agent) to the initiation of study drug must be \\> 5 times the half-life of the agent or \\> 21 days (whichever is shorter).\n* Resolution of non-immune-related AEs secondary to prior anticancer therapy (excluding alopecia and peripheral neuropathy) to ≤ Grade 1 per NCI-CTCAE version 5.0 or higher, and complete resolution of immune-related AEs secondary to prior checkpoint inhibitor therapy.\n* Serum creatinine clearance ≥ 30 mL\u002Fmin per Cockcroft-Gault formula.\n* Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN if elevated because of liver metastases or documented Gilbert's syndrome).\n* Aspartate aminotransferase\u002Fserum glutamic oxaloacetic transaminase (AST\u002FSGOT) and alanine aminotransferase\u002Fserum glutamic pyruvic transaminase (ALT\u002FSGPT) \\\u003C 2.5 × ULN or \\\u003C 5 × ULN for patients with known liver metastases.\n* Adequate hematologic function, defined as absolute neutrophil count ≥ 1.0 × 10\\^9\u002FL, hemoglobin ≥ 8.0 g\u002FdL, and platelet count ≥ 75 × 10\\^9\u002FL.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Ejection fraction ≥ 50%, as measured by echocardiogram, multigated acquisition scan, nuclear stress test, or equivalent modality.\n* Willingness of male and female patients who are not surgically sterile or postmenopausal to use medically acceptable methods of birth control for the duration of the study treatment period, including 90 days after the last dose of CHS-114, 4 months after the last dose of toripalimab; male patients must refrain from donating sperm during this period. Sexually active men, and women using oral contraceptive pills, should also use barrier contraception. Azoospermic male patients and women of childbearing potential who are continuously not heterosexually active are exempt from contraceptive requirements.\n\nAdditional Inclusion Criteria - Arms 1b and 2 only\n\n* Histologically or cytologically confirmed advanced or metastatic HNSCC that has progressed during or after a platinum-based chemotherapy and\u002For a programmed cell death receptor (PD)-1 or PD ligand 1 (PD-L1) targeting agent (separately or in combination therapy).\n* Metastatic or locoregionally recurrent HNSCC malignancy that is incurable by surgery or radiotherapy.\n* Arm 1b only, participants must have tumor tissue that is accessible for pretreatment and on-treatment tumor biopsy in the opinion of the Investigator and be willing and consent to undergo pretreatment and on-treatment biopsies per protocol.\n\nAdditional Inclusion Criteria - Arm 3 only\n\n* Histologically or cytologically confirmed locally advanced or metastatic HNSCC (primary tumor location of oral cavity, oropharynx, hypopharynx, or larynx). Participants may not have a primary tumor site of nasopharynx (any histology).\n* Participants should have been treated with anti-PD-1\u002FPD-L1-directed systemic therapy for incurable recurrent, advanced, or metastatic disease and experienced progressive disease. targeting agent (separately or in combination therapy).\n* Metastatic or locoregionally recurrent HNSCC malignancy that is incurable by surgery or radiotherapy.\n* Consent to provide HPV status assessed by p16 and results from baseline PD-L1 IHC assay score.\n* Consent to provide tumor tissue samples is required for enrollment.\n\nKey Exclusion Criteria - Arms 1a, 1b, 2, and 3\n\n* Previously received an anti-CCR8 antibody or anti-CCR8 targeted therapy.\n* History of Grade 4 allergic or anaphylactic reaction to any monoclonal antibody therapy or any excipient in the study drugs.\n* Major surgery within 4 weeks prior to Screening.\n* Unstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition including pneumonitis and\u002For interstitial lung disease, uncontrolled diabetes, symptomatic fistula) or any important medical illness or abnormal laboratory finding that would, in the Investigator's judgment, increase the risk to the patient associated with his or her participation in the study.\n\nAdditional Exclusion Criteria - Arms 1b and 2 only\n\n* Received \\> 4 prior systemic regimens for advanced\u002Fmetastatic disease.\n* Nasopharyngeal carcinoma or nasal cavity malignancies other than HNSCC (eg, adenocarcinoma and variants, neuroendocrine tumors, mucosal melanoma).\n* Receiving chronic anti-coagulation therapy (eg, warfarin, enoxaparin) that cannot be safely discontinued temporarily for the required biopsies (only for patients who provide tumor biopsies).\n\nAdditional Exclusion Criteria - Arm 3\n\n• Received ≥ 2 prior systemic regimens for advanced\u002Fmetastatic disease.",true,{"count":94,"type":20},87,[23],"This is a Phase 1, open-label, first-in-human, dose-escalation and expansion study of CHS-114, a monoclonal antibody that targets CCR8, as a monotherapy in patients with solid tumors.",[27,98],"Head and Neck Squamous Cell Carcinoma",[100,101,102,103,34,104,105,106,107,108,109],"metastatic solid tumors","advanced solid tumors","Phase 1","SRF114","safety","efficacy","immunotherapy","cancer","immuno-oncology","CHS-114","2026-03-17",{"date":112,"type":47},"2026-03-19",{"date":114,"type":47},"2022-12-15",{"date":116,"type":20},"2027-01-01",{"name":53,"class":54},16,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":21,"phases":128,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":4},"100546022","phase-1-a-study-of-chs-1000-in-participants-with-advanced-or-metastatic-solid-tumors-100546022","NCT06389526","A Study of CHS-1000 in Participants With Advanced or Metastatic Solid Tumors","A Phase 1, Multicenter, Open-Label Study of CHS-1000 as a Single Agent and in Combination With Toripalimab-tpzi in Participants With Advanced or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Histopathologically or cytologically confirmed diagnosis of advanced or metastatic unresectable solid tumors (excluding glioblastoma multiforme (GBM)) by tissue biopsy or archival tumor specimen. Unresectable tumors are defined as tumors with lesions in which clear surgical excision margins cannot be obtained, in close proximity to major blood vessels, not with oligometastatic and with advanced organ and lymph node (LN) involvement, and not leading to significant functional compromise as determined by surgical consult or Tumor Board.\n* Participants must have been previously treated or be ineligible for, or intolerant of, available approved standard therapies known to confer clinical benefit (including immunotherapy), or for whom no effective standard therapy exists.\n* At least 1 measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by the investigator.\n\nKey Exclusion Criteria:\n\n* Concurrent enrollment in another clinical study or participation in another clinical study within 28 days prior to the 1st dose of CHS-1000, except for observational (noninterventional) studies or the follow-up period of an interventional study.\n* Current or prior use of systemic anticancer treatment, including but not limited to chemotherapy, immunotherapy, biologic treatment, hormone therapy, and targeted therapy, if within 8 weeks or 5 half-lives (whichever is shorter) for biologic therapies, or if within 28 days for most other anticancer therapies, prior to the 1st dose of CHS-1000.\n* Concurrent or prior radiotherapy within 28 days prior to the 1st dose of CHS-1000 or unresolved treatment-related radiation toxicity. Limited local radiotherapy for palliative intent (eg, to a single site of metastatic disease) is permitted within 28 days prior to the 1st dose of CHS-1000 provided that the participant has no evidence of or has recovered from any treatment-related radiation toxicity.\n\nNote: Other protocol-defined inclusion and exclusion criteria may apply.",{"count":127,"type":20},48,[23],"The primary purpose of this trial is to assess the tolerability and safety of CHS-1000 alone and in combination with toripalimab-tpzi in participants with advanced solid tumors.",[131],"Advanced or Metastatic Solid Tumors",[133,134,74,135,136],"CHS-1000","Tumors","ILT4","LILRB2","NOT_YET_RECRUITING","2024-09-17",{"date":140,"type":47},"2024-09-19",{"date":142,"type":20},"2025-02-15",{"date":144,"type":20},"2028-05-30",{"name":53,"class":54},""]