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The main purpose of this study is to evaluate the safety and preliminary efficacy of CHS-114 in combination with toripalimab and/or other standard of care (SOC) compound(s) in participants with advanced or metastatic solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A - Arm A1: CHS-114 Dose A + Toripalimab | Experimental | Participants will be treated with dose A of CHS-114 administered as an intravenous (IV) infusion in combination with toripalimab every 3 weeks (Q3W). |
|
| Cohort A - Arm A2: CHS-114 Dose B + Toripalimab | Experimental | Participants will be treated with dose B of CHS-114 administered as an IV infusion in combination with toripalimab Q3W. |
|
| Cohort B - Arm B1: CHS-114 Dose A + Toripalimab | Experimental | Participants will be treated with dose A of CHS-114 administered as an IV infusion in combination with toripalimab Q3W. |
|
| Cohort B - Arm B2: CHS-114 Dose B + Toripalimab | Experimental | Participants will be treated with dose B of CHS-114 administered as an IV infusion in combination with toripalimab Q3W. |
|
| Cohort C - Arm C: CHS-114 Dose B + Toripalimab + 5 fluorouracil (5 FU) + Cisplatin | Experimental | Participants will be treated with dose B of CHS-114 administered as an IV infusion in combination with toripalimab, 5 FU, and cisplatin Q3W. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHS-114 | Drug | Solution for infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From first dose of study drug until 90 days after the last dose of study drug (up to approximately 2.25 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Based on Investigator Assessment | ORR is defined as percentage of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1. | Up to approximately 2.25 years |
| Duration of Response (DOR) Per RECIST v1.1 Based on Investigator Assessment |
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Key Inclusion Criteria:
Cohort A (2L Gastric, Gastro-esophageal-junction [GEJ], Esophageal Adenocarcinoma [EAC]) Specific Inclusion Criteria:
Cohort B (2L Esophageal Squamous Cell Carcinoma [ESCC]) - Specific Inclusion Criteria:
Cohort C (1L Esophageal Squamous Cell Carcinoma [ESCC]) - Specific Inclusion Criteria:
Cohort D, Arms D1 and D2 (4L+ Colorectal Carcinoma [CRC]) - Specific Inclusion Criteria:
Key Exclusion Criteria:
Cohort A (2L Gastric, Gastro-esophageal-junction [GEJ], Esophageal Adenocarcinoma [EAC]) Specific Exclusion Criteria:
Cohort B (2L Esophageal Squamous Cell Carcinoma [ESCC]) - Specific Exclusion Criteria:
Cohort C (1L Esophageal Squamous Cell Carcinoma [ESCC]) - Specific Exclusion Criteria:
Note: Other protocol-specified inclusion/exclusion criteria apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations Team | Contact | +1-800-794-5434 | clinicaltrials@coherus.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Arizona Cancer Center | Withdrawn | Tucson | Arizona | 85724 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41423415 | Derived | Wang X, Kapoor VN, Chin DJ, Klakamp SL, Baruffaldi F, Mohan JF, Haines R, Dulak A, Panduro M, Ren Y, Masia R, Hill JA, LaVallee TM, Rajasekaran N. CHS-114: An Afucosylated Anti-CCR8 Monoclonal Antibody that Selectively Depletes Intratumoral Treg Cells and Induces Antitumor Immune Responses. Mol Cancer Ther. 2026 May 4;25(5):685-700. doi: 10.1158/1535-7163.MCT-25-0367. |
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|
| Experimental: Cohort D - Arm D1 (Liver Mets): CHS-114 + Toripalimab | Experimental | Participants will be treated with CHS-114 administered as an IV infusion in combination with toripalimab Q3W. |
|
| Experimental: Cohort D - Arm D2 (Non-Liver Mets): CHS-114 + Toripalimab | Experimental | Participants will be treated with CHS-114 administered as an IV infusion in combination with toripalimab Q3W. |
|
| Toripalimab | Drug | Solution for infusion |
|
| 5 Fluorouracil | Drug | Solution for infusion |
|
| Cisplatin | Drug | Solution for infusion |
|
DOR is defined as the time from first documentation of response (CR or PR) to first radiographic documentation of progressive disease or death due to any cause according to RECIST v1.1. |
| Up to approximately 2.25 years |
| Disease Control Rate (DCR) Per RECIST v1.1 Based on Investigator Assessment | DCR is defined as the percentage of participants who achieve a confirmed CR or PR or stable disease (SD) lasting ≥ 12 weeks according to RECIST v1.1. | Up to approximately 2.25 years |
| Progression-free Survival (PFS) Per RECIST v1.1 Based on Investigator Assessment | PFS is defined as the time of the first dose of study treatment to the time of the first documented unequivocal disease progression assessed per RECIST v1.1 or death due to any cause (whichever occurs first). | Up to approximately 2.25 years |
| Landmark PFS Rates | Months 6, 9, and 12 |
| Maximum Observed Serum Concentration (Cmax) of CHS-114 | Up to approximately 2.25 years (pre-infusion and up to 336 hours post-infusion) |
| Time to Reach Cmax (Tmax) of CHS-114 | Up to approximately 2.25 years (pre-infusion and up to 336 hours post-infusion) |
| Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of CHS-114 | Up to approximately 2.25 years (pre-infusion and up to 336 hours post-infusion) |
| Number of Participants With Anti-drug Antibodies (ADAs) | Up to approximately 2.25 years |
| City of Hope |
| Recruiting |
| Duarte |
| California |
| 91010 |
| United States |
|
| University of Colorado - Aurora Cancer Center | Recruiting | Aurora | Colorado | 80045 | United States |
|
| Winship Cancer Center - Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
|
| Ochsner Health | Recruiting | New Orleans | Louisiana | 70121 | United States |
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| Henry Ford Health System | Recruiting | Detroit | Michigan | 48202 | United States |
|
| Comprehensive Cancer Center of Nevada | Recruiting | Las Vegas | Nevada | 89169 | United States |
|
| Christus St Vincent Regional Medical Center | Recruiting | Santa Fe | New Mexico | 87505 | United States |
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| START New York | Recruiting | Lake Success | New York | 11042 | United States |
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| David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
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| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 11766 | United States |
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| University of Pittsburg Medical Center _UPMC Hillman Cancer Center | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
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| Prisma Health Cancer Institute | Recruiting | Greenville | South Carolina | 29605 | United States |
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| SCRI Oncology Partners | Recruiting | Nashville | Tennessee | 37203 | United States |
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| Texas Oncology - Central South | Recruiting | Austin | Texas | 78731 | United States |
|
| START San Antonio, LLC. | Recruiting | San Antonio | Texas | 78229 | United States |
|
| Huntsman Cancer Institute, University of Utah | Recruiting | Salt Lake City | Utah | 84112 | United States |
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| START Mountain Region, LLC. | Recruiting | West Valley City | Utah | 84119 | United States |
|
| Virginia Cancer Specialists | Recruiting | Fairfax | Virginia | 22031 | United States |
|
| Virginia Oncology Associates | Withdrawn | Norfolk | Virginia | 23502 | United States |
| Changhua Christian Hospital | Recruiting | Chang-hua | Taiwan |
|
| E-Da Cancer Hospital | Recruiting | Kaohsiung City | 824 | Taiwan |
|
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Recruiting | Kaohsiung City | Taiwan |
|
| Taichung Veterans General Hospital | Recruiting | Taichung | 40705 | Taiwan |
|
| China Medical University Hospital | Recruiting | Taichung | Taiwan |
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| National Cheng Kung University Hospital | Recruiting | Tainan | 704 | Taiwan |
|
| Chi Mei Hospital | Recruiting | Tainan | 736 | Taiwan |
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| National Taiwan University Hospital | Recruiting | Taipei | 10002 | Taiwan |
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| Taipei Veterans General Hospital | Recruiting | Taipei | 112 | Taiwan |
|
| Mackay Memorial Hospital | Recruiting | Taipei | Taiwan |
|
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D009369 | Neoplasms |
| D013274 | Stomach Neoplasms |
| C562730 | Adenocarcinoma Of Esophagus |
| D000077277 | Esophageal Squamous Cell Carcinoma |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
| D005472 | Fluorouracil |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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