A Study of CHS-114 (Tagmokitug) in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors

July 14, 2026 updated by: Coherus Oncology, Inc.

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

154

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Chang-hua, Taiwan
        • Recruiting
        • Changhua Christian Hospital
        • Contact:
        • Principal Investigator:
          • Kuan-Ming Lai, MD
      • Kaohsiung City, Taiwan
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Jaw-Yuan Wang, MD
      • Kaohsiung City, Taiwan, 824
        • Recruiting
        • E-Da Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Meng-Che Hsieh, MD
      • Taichung, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital
        • Contact:
        • Principal Investigator:
          • Hsin-Chen Lin, MD
      • Taichung, Taiwan
        • Recruiting
        • China Medical University Hospital
        • Contact:
        • Principal Investigator:
          • Li-Yuan Bai, MD, PhD
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital
        • Principal Investigator:
          • Chia-Jui Yen, MD
        • Contact:
      • Tainan, Taiwan, 736
        • Recruiting
        • Chi Mei Hospital
        • Contact:
        • Principal Investigator:
          • Chien-Liang Lin, MD
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital
        • Principal Investigator:
          • Chia-Chi Lin, MD
        • Contact:
      • Taipei, Taiwan
        • Recruiting
        • Mackay Memorial Hospital
        • Principal Investigator:
          • Nai-Wen Su, MD
        • Contact:
      • Taipei, Taiwan, 112
        • Recruiting
        • Taipei Veterans General Hospital
        • Principal Investigator:
          • Ming-Huang Chen, MD
        • Contact:
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Withdrawn
        • The University of Arizona Cancer Center
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Contact:
        • Principal Investigator:
          • Dani Castillo, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado - Aurora Cancer Center
        • Principal Investigator:
          • Sunnie Kim, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Winship Cancer Center - Emory University
        • Contact:
        • Principal Investigator:
          • Oluwadunni Emiloju, MD
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Health
        • Principal Investigator:
          • Jonathan Mizrahi, MD
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health System
        • Principal Investigator:
          • Gazala Khan, MD
        • Contact:
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Recruiting
        • Comprehensive Cancer Center of Nevada
        • Principal Investigator:
          • Kyaw Thein, MD
        • Contact:
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • Recruiting
        • Christus St Vincent Regional Medical Center
        • Principal Investigator:
          • Andrea Teague, MD
        • Contact:
    • New York
      • Lake Success, New York, United States, 11042
        • Recruiting
        • START New York
        • Contact:
        • Principal Investigator:
          • Geraldine O'Sullivan Coyne, MD
      • New York, New York, United States, 10065
        • Recruiting
        • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
        • Contact:
        • Principal Investigator:
          • Yelena Janjigian, MD
      • New York, New York, United States, 11766
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Contact:
        • Principal Investigator:
          • Dan Feng, MD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • University of Pittsburg Medical Center _UPMC Hillman Cancer Center
        • Principal Investigator:
          • Anwaar Saeed, MD
        • Contact:
    • South Carolina
      • Greenville, South Carolina, United States, 29605
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners
        • Contact:
        • Principal Investigator:
          • Meredith S Pelster, MD
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • Texas Oncology - Central South
        • Contact:
        • Principal Investigator:
          • Vivian Cline, MD
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • START San Antonio, LLC.
        • Principal Investigator:
          • Amita Patnaik, MD
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute, University of Utah
        • Contact:
        • Principal Investigator:
          • Christopher Nevala-Plagemann, MD
      • West Valley City, Utah, United States, 84119
        • Recruiting
        • START Mountain Region, LLC.
        • Principal Investigator:
          • William McKean, MD
        • Contact:
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Virginia Cancer Specialists
        • Contact:
        • Principal Investigator:
          • Mohamad A Salkeni, MD
      • Norfolk, Virginia, United States, 23502
        • Withdrawn
        • Virginia Oncology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: Toripalimab
Solution for infusion
Drug: CHS-114
Solution for infusion
Experimental: 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.
Drug: Toripalimab
Solution for infusion
Drug: CHS-114
Solution for infusion
Experimental: 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.
Drug: Toripalimab
Solution for infusion
Drug: CHS-114
Solution for infusion
Experimental: 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.
Drug: Toripalimab
Solution for infusion
Drug: CHS-114
Solution for infusion
Experimental: 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.
Drug: Toripalimab
Solution for infusion
Drug: CHS-114
Solution for infusion
Drug: 5 Fluorouracil
Solution for infusion
Drug: Cisplatin
Solution for infusion
Experimental: 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.
Drug: Toripalimab
Solution for infusion
Drug: CHS-114
Solution for infusion
Experimental: 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.
Drug: Toripalimab
Solution for infusion
Drug: CHS-114
Solution for infusion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: Up to approximately 2.25 years
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
Time Frame: Up to approximately 2.25 years
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
Time Frame: Up to approximately 2.25 years
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
Time Frame: Months 6, 9, and 12
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)
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)
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)
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
Up to approximately 2.25 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coherus Oncology, Inc.

Investigators

  • Study Director: Study Director, Coherus Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

October 23, 2024

First Posted (Actual)

October 24, 2024

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHS-114-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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