Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 1

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)

NCT ID: NCT06657144Sponsor: Coherus Oncology, Inc.Last updated: 2026-06-12

Summary

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.

Arms & interventions

  • DrugCHS-114

    Solution for infusion

  • DrugToripalimab

    Solution for infusion

  • Drug5 Fluorouracil

    Solution for infusion

  • DrugCisplatin

    Solution for infusion

Outcome measures

Primary

  • Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Time frame: From first dose of study drug until 90 days after the last dose of study drug (up to approximately 2.25 years)

Secondary

  • Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Based on Investigator Assessment

    Time frame: Up to approximately 2.25 years

  • Duration of Response (DOR) Per RECIST v1.1 Based on Investigator Assessment

    Time frame: Up to approximately 2.25 years

  • Disease Control Rate (DCR) Per RECIST v1.1 Based on Investigator Assessment

    Time frame: Up to approximately 2.25 years

  • Progression-free Survival (PFS) Per RECIST v1.1 Based on Investigator Assessment

    Time frame: Up to approximately 2.25 years

  • Landmark PFS Rates

    Time frame: Months 6, 9, and 12

  • Maximum Observed Serum Concentration (Cmax) of CHS-114

    Time frame: Up to approximately 2.25 years (pre-infusion and up to 336 hours post-infusion)

  • Time to Reach Cmax (Tmax) of CHS-114

    Time frame: 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

    Time frame: Up to approximately 2.25 years (pre-infusion and up to 336 hours post-infusion)

  • Number of Participants With Anti-drug Antibodies (ADAs)

    Time frame: Up to approximately 2.25 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Key Inclusion Criteria: * At least 1 measurable lesion based on RECIST v1.1 as determined by the Investigator. * 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. Cohort A (2L Gastric, Gastro-esophageal-junction \[GEJ\], Esophageal Adenocarcinoma \[EAC\]) Specific Inclusion Criteria: * 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. Cohort B (2L Esophageal Squamous Cell Carcinoma \[ESCC\]) - Specific Inclusion Criteria: * 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. Cohort C (1L Esophageal Squamous Cell Carcinoma \[ESCC\]) - Specific Inclusion Criteria: * 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. Cohort D, Arms D1 and D2 (4L+ Colorectal Carcinoma \[CRC\]) - Specific Inclusion Criteria: * 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 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/tipiracil, fruqintinib 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. Key Exclusion Criteria: * History of prior malignancy other than the cancer under study that is progressing or has required active treatment within the past 3 years. * 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. Cohort A (2L Gastric, Gastro-esophageal-junction \[GEJ\], Esophageal Adenocarcinoma \[EAC\]) Specific Exclusion Criteria: * 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). Cohort B (2L Esophageal Squamous Cell Carcinoma \[ESCC\]) - Specific Exclusion Criteria: * 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). Cohort C (1L Esophageal Squamous Cell Carcinoma \[ESCC\]) - Specific Exclusion Criteria: * 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. Note: Other protocol-specified inclusion/exclusion criteria apply.

Study locations (20)

The University of Arizona Cancer Center

Tucson, Arizona, 85724

Withdrawn

City of Hope

Duarte, California, 91010

Recruiting
Edwin Smura · Contact
Dani Castillo, MD · Principal Investigator

University of Colorado - Aurora Cancer Center

Aurora, Colorado, 80045

Recruiting
Sunnie Kim, MD · Principal Investigator

Winship Cancer Center - Emory University

Atlanta, Georgia, 30322

Recruiting
Oluwadunni Emiloju, MD · Principal Investigator

Ochsner Health

New Orleans, Louisiana, 70121

Recruiting
Lauren Roddy · Contact
Jonathan Mizrahi, MD · Principal Investigator

Henry Ford Health System

Detroit, Michigan, 48202

Recruiting
Gazala Khan, MD · Principal Investigator

Comprehensive Cancer Center of Nevada

Las Vegas, Nevada, 89169

Recruiting
Kyaw Thein, MD · Principal Investigator

Christus St Vincent Regional Medical Center

Santa Fe, New Mexico, 87505

Recruiting
Christopher Gallegos · Contact
Andrea Teague, MD · Principal Investigator

START New York

Lake Success, New York, 11042

Recruiting
Geraldine O'Sullivan Coyne, MD · Principal Investigator

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting
Amin Yaqubie · Contact
Yelena Janjigian, MD · Principal Investigator

Icahn School of Medicine at Mount Sinai

New York, New York, 11766

Recruiting
Joseph Waters · Contact
Dan Feng, MD · Principal Investigator

University of Pittsburg Medical Center _UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

Recruiting
Nicholas Kerin · Contact
Anwaar Saeed, MD · Principal Investigator

Prisma Health Cancer Institute

Greenville, South Carolina, 29605

Recruiting
Jill Roemmich · Contact
Ki Chung, MD · Principal Investigator

SCRI Oncology Partners

Nashville, Tennessee, 37203

Recruiting
Karlie Williams · Contact
Meredith S Pelster, MD · Principal Investigator

Texas Oncology - Central South

Austin, Texas, 78731

Recruiting
Marian Heaven · Contact
Vivian Cline, MD · Principal Investigator

START San Antonio, LLC.

San Antonio, Texas, 78229

Recruiting
Amita Patnaik, MD · Principal Investigator

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84112

Recruiting
Christopher Nevala-Plagemann, MD · Principal Investigator

START Mountain Region, LLC.

West Valley City, Utah, 84119

Recruiting
William McKean, MD · Principal Investigator

Virginia Cancer Specialists

Fairfax, Virginia, 22031

Recruiting
Marcy Sullivan · Contact
Mohamad A Salkeni, MD · Principal Investigator

Virginia Oncology Associates

Norfolk, Virginia, 23502

Withdrawn

References

  • 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.(PubMed)