A Study of CHS-114 in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors
NCT ID: NCT06657144
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
154 participants
INTERVENTIONAL
2025-04-01
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A - Arm A1: CHS-114 Dose A + Toripalimab
Participants will be treated with dose A of CHS-114 administered as an intravenous (IV) infusion in combination with toripalimab every 3 weeks (Q3W).
CHS-114
Solution for infusion
Toripalimab
Solution for infusion
Cohort A - Arm A2: CHS-114 Dose B + Toripalimab
Participants will be treated with dose B of CHS-114 administered as an IV infusion in combination with toripalimab Q3W.
CHS-114
Solution for infusion
Toripalimab
Solution for infusion
Cohort B - Arm B1: CHS-114 Dose A + Toripalimab
Participants will be treated with dose A of CHS-114 administered as an IV infusion in combination with toripalimab Q3W.
CHS-114
Solution for infusion
Toripalimab
Solution for infusion
Cohort B - Arm B2: CHS-114 Dose B + Toripalimab
Participants will be treated with dose B of CHS-114 administered as an IV infusion in combination with toripalimab Q3W.
CHS-114
Solution for infusion
Toripalimab
Solution for infusion
Cohort C - Arm C: CHS-114 Dose B + Toripalimab + 5 fluorouracil (5 FU) + Cisplatin
Participants will be treated with dose B of CHS-114 administered as an IV infusion in combination with toripalimab, 5 FU, and cisplatin Q3W.
CHS-114
Solution for infusion
Toripalimab
Solution for infusion
5 Fluorouracil
Solution for infusion
Cisplatin
Solution for infusion
Experimental: Cohort D - Arm D1 (Liver Mets): CHS-114 + Toripalimab
Participants will be treated with CHS-114 administered as an IV infusion in combination with toripalimab Q3W.
CHS-114
Solution for infusion
Toripalimab
Solution for infusion
Experimental: Cohort D - Arm D2 (Non-Liver Mets): CHS-114 + Toripalimab
Participants will be treated with CHS-114 administered as an IV infusion in combination with toripalimab Q3W.
CHS-114
Solution for infusion
Toripalimab
Solution for infusion
Interventions
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CHS-114
Solution for infusion
Toripalimab
Solution for infusion
5 Fluorouracil
Solution for infusion
Cisplatin
Solution for infusion
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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)/proficient mismatch repair (pMMR).
* 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)/programmed death ligand 1 (PD-L1)-directed therapy (that is, in the second line setting).
* Consent to provide tumor tissue samples (baseline and on-treatment) is required for enrollment.
* Histologically or cytologically documented unresectable, locally advanced or metastatic ESCC.
* Progressed during or after first line systemic therapy including a doublet of platinum and fluoropyrimidine or paclitaxel with or without anti-PD-1/PD-L1-directed therapy or anti-CTLA-4 and anti-PD-1/PD-L1-directed combination therapy.
* Consent to provide results from prior PD-L1 IHC assay score by FDA-approved or equivalent PD-L1 IHC diagnostic tests.
* Consent to provide archival tumor tissue sample (baseline) is required for enrolment.
* Histologically or cytologically documented unresectable, locally advanced or metastatic ESCC.
* Consent to provide baseline tumor tissue is required.
* Consent to provide results from prior PD-L1 IHC assay score by FDA-approved or equivalent PD-L1 IHC diagnostic tests.
* Calculated creatinine clearance ≥60 mL/min.
* Histologically and/or cytologically documented unresectable advanced or metastatic colorectal adenocarcinoma. RAS, BRAF, and microsatellite instability/mismatch repair status for each participant must be documented, according to country level guidelines.
* Participants who have no approved standard therapies with a proven clinical benefit available in the participant's country. These therapies include 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, trifluridine/tipiracil or regorafenib, and a BRAF inhibitor (ie, encorafenib) in BRAF V600E mutant).
* 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.
* Consent to provide baseline tumor tissue sample is required for enrolment.
Exclusion Criteria
* Symptomatic or untreated central nervous system metastases, including leptomeningeal metastases, requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids.
* 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.
* Prior exposure to anti-C-C motif chemokine receptor 8 (CCR8) antibody.
* History of Grade 4 allergic or anaphylactic reaction to any monoclonal antibody (mAb) therapy or any excipient in the study treatment.
* 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.
* Any condition that, in the opinion of the Investigator or Sponsor, would interfere with the interpretation of study results.
* Received ≥ 2 prior systemic anticancer therapies for advanced or metastatic disease.
* 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).
* Received ≥ 2 prior systemic anticancer therapies for advanced or metastatic disease.
* 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).
* Received ≥ 1 prior systemic anticancer therapies for advanced or metastatic disease.
* Participants who progressed during or within 6 months following the last dose of neoadjuvant, or perioperative therapy with curative intent.
* 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).
* Known dihydropyrimidine dehydrogenase deficiency or thymidine synthase gene polymorphism predisposing the participant to 5-FU toxicity.
* Known allergies to 5-FU or cisplatin.
18 Years
ALL
No
Sponsors
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Coherus Oncology, Inc.
INDUSTRY
Responsible Party
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Locations
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The University of Arizona Cancer Center
Tucson, Arizona, United States
City of Hope
Duarte, California, United States
University of Colorado - Aurora Cancer Center
Aurora, Colorado, United States
Winship Cancer Center - Emory University
Atlanta, Georgia, United States
Ochsner Health
New Orleans, Louisiana, United States
Christus St Vincent Regional Medical Center
Santa Fe, New Mexico, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Pittsburg Medical Center _UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Prisma Health Cancer Institute
Greenville, South Carolina, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Texas Oncology - Central South
Austin, Texas, United States
START San Antonio, LLC.
San Antonio, Texas, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States
START Mountain Region, LLC.
West Valley City, Utah, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Taichung Veterans General Hospital
Taichung, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Prisca Zimmerman
Role: primary
Edwin Smura
Role: primary
Emily Harper
Role: primary
Kathleen Coleman
Role: primary
Lauren Roddy
Role: primary
Christopher Gallegos
Role: primary
Amin Yaqubie
Role: primary
Nicholas Kerin
Role: primary
Jill Roemmich
Role: primary
Karlie Williams
Role: primary
Marian Heaven
Role: primary
Isabel Jimenez
Role: primary
Jamie White
Role: primary
Marie Asay
Role: primary
Marcy Sullivan
Role: primary
Amber Ingram
Role: primary
Yi-Ru Lai
Role: primary
Ya-Hui Ding
Role: primary
Ting-Yu Tseng
Role: primary
Jia Ping Jiang
Role: primary
Chiu-Mei Wang
Role: primary
Other Identifiers
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CHS-114-102
Identifier Type: -
Identifier Source: org_study_id