A Study of CHS-114 (Tagmokitug) in Combination With Toripalimab and/or 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)
1 other identifier
interventional
154
2 countries
30
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2025
Typical duration for phase_1
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2024
CompletedFirst Posted
Study publicly available on registry
October 24, 2024
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
March 31, 2026
March 1, 2026
2.8 years
October 23, 2024
March 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (9)
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Based on Investigator Assessment
Up to approximately 2.25 years
Duration of Response (DOR) Per RECIST v1.1 Based on Investigator Assessment
Up to approximately 2.25 years
Disease Control Rate (DCR) Per RECIST v1.1 Based on Investigator Assessment
Up to approximately 2.25 years
Progression-free Survival (PFS) Per RECIST v1.1 Based on Investigator Assessment
Up to approximately 2.25 years
Landmark PFS Rates
Months 6, 9, and 12
- +4 more secondary outcomes
Study Arms (7)
Cohort A - Arm A1: CHS-114 Dose A + Toripalimab
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants will be treated with dose B of CHS-114 administered as an IV infusion in combination with toripalimab, 5 FU, and cisplatin Q3W.
Experimental: Cohort D - Arm D1 (Liver Mets): CHS-114 + Toripalimab
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants will be treated with CHS-114 administered as an IV infusion in combination with toripalimab Q3W.
Interventions
Solution for infusion
Solution for infusion
Solution for infusion
Solution for infusion
Eligibility Criteria
You may qualify if:
- 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.
- 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 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).
- +2 more criteria
You may not qualify if:
- 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.
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
The University of Arizona Cancer Center
Tucson, Arizona, 85724, United States
City of Hope
Duarte, California, 91010, United States
University of Colorado - Aurora Cancer Center
Aurora, Colorado, 80045, United States
Winship Cancer Center - Emory University
Atlanta, Georgia, 30322, United States
Ochsner Health
New Orleans, Louisiana, 70121, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Comprehensive Cancer Center of Nevada
Las Vegas, Nevada, 89169, United States
Christus St Vincent Regional Medical Center
Santa Fe, New Mexico, 87505, United States
START New York
Lake Success, New York, 11042, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 11766, United States
University of Pittsburg Medical Center _UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Prisma Health Cancer Institute
Greenville, South Carolina, 29605, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Texas Oncology - Central South
Austin, Texas, 78731, United States
START San Antonio, LLC.
San Antonio, Texas, 78229, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112, United States
START Mountain Region, LLC.
West Valley City, Utah, 84119, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Changhua Christian Hospital
Chang-hua, Taiwan
E-Da Cancer Hospital
Kaohsiung City, 824, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
China Medical University Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
Chi Mei Hospital
Tainan, 736, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Mackay Memorial Hospital
Taipei, Taiwan
Related Publications (1)
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. 2025 Dec 22. doi: 10.1158/1535-7163.MCT-25-0367. Online ahead of print.
PMID: 41423415DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2024
First Posted
October 24, 2024
Study Start
April 1, 2025
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2028
Last Updated
March 31, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share