CHS-114: An Afucosylated Anti-CCR8 Monoclonal Antibody that Selectively Depletes Intratumoral Treg Cells and Induces Antitumor Immune Responses.
Xiaoguang Wang, Varun N Kapoor, Daniel J Chin...
https://pubmed.ncbi.nlm.nih.gov/41423415Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID06657144
A Phase 1B Study of CHS-114 With Toripalimab With or Without Other Treatments in Advanced or Metastatic Solid Tumors
Led by Coherus Oncology, Inc. · Updated on 2026-04-06
154
Participants Needed
30
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and early effectiveness of the drug CHS-114 combined with toripalimab and possibly other standard treatments in adults with advanced or metastatic solid tumors. This Phase 1B trial aims to understand how these combinations work in participants with various solid cancers, including gastric, esophageal, and colorectal cancers, who have progressed after previous treatments. Participants will receive intravenous infusions of CHS-114 at different doses combined with toripalimab every three weeks. Some groups may also receive additional drugs like 5 fluorouracil and cisplatin. The study includes multiple groups receiving different combinations to assess safety and response. Treatment will continue with regular infusions, and some groups have specific criteria based on cancer type and prior therapies. Throughout the study, participants will have regular evaluations for side effects, tumor response using RECIST criteria, and blood tests to measure drug levels and immune responses. Researchers will monitor adverse events from the first dose until 90 days after the last dose, with follow-up lasting up to about 2.25 years. The study includes tumor tissue sampling and ongoing assessments to understand treatment impact and safety over time.
CONDITIONS
Brief Title
A Study of CHS-114 (Tagmokitug) in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- At least 1 measurable tumor lesion according to RECIST v1.1
- Acute effects of prior therapy resolved to baseline or Grade 1 per NCI CTCAE v5.0, except for non-safety risk events
- For Cohort A: Unresectable, advanced or metastatic HER2-negative, MSS/pMMR gastric, GEJ, or esophageal adenocarcinoma progressed after first line therapy including platinum and fluoropyrimidine
- Consent to provide tumor tissue samples for Cohort A
- For Cohort B: Unresectable, advanced or metastatic esophageal squamous cell carcinoma progressed after first line systemic therapy
- Consent to provide PD-L1 assay results and archival tumor tissue for Cohort B
- For Cohort C: Unresectable, advanced or metastatic esophageal squamous cell carcinoma, no more than one prior systemic therapy
- Consent to provide baseline tumor tissue and PD-L1 assay results for Cohort C
- Creatinine clearance ≥ 60 mL/min for Cohort C
- For Cohort D: Unresectable advanced or metastatic colorectal adenocarcinoma with documented RAS, BRAF, and MSI/MMR status
- No available proven therapies per investigator in participant's country for Cohort D
- Consent to provide baseline tumor tissue for Cohort D
You will not qualify if you...
- History of another progressing or actively treated cancer within the past 3 years
- Untreated or symptomatic central nervous system metastases requiring treatment
- Major surgery within 28 days before first study dose or scheduled surgery during study
- Prior exposure to anti-CCR8 antibody
- History of severe allergic or anaphylactic reaction to monoclonal antibodies or study drug components
- Active uncontrolled infections including hepatitis B, hepatitis C, or HIV/AIDS-related illness
- Any condition interfering with study result interpretation per investigator or sponsor
- For Cohorts A and B: More than 2 prior systemic therapies for advanced/metastatic disease
- High risk for esophageal fistula by clinical or imaging assessment in Cohorts A, B, and C
- For Cohort C: More than 1 prior systemic therapy for advanced/metastatic disease
- Progression during or within 6 months after neoadjuvant or perioperative therapy for Cohort C
- Known deficiency or gene polymorphism causing 5-FU toxicity or allergies to 5-FU or cisplatin in Cohort C
AI-Screening
AI-Powered Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to approximately 2.25 years
Participants receive CHS-114 and toripalimab, with or without 5 fluorouracil and cisplatin, administered as intravenous infusions every 3 weeks.
Infusions every 3 weeks (Q3W)
Follow-up
Duration - Up to 90 days after last dose
Participants are monitored for treatment-emergent adverse events and response to therapy for up to 90 days after the last dose of study drug.
Visits as needed for safety and assessment
Trial Site Locations
Total: 30 locations
1
The University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
Withdrawn
2
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
3
University of Colorado - Aurora Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Winship Cancer Center - Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
5
Ochsner Health
New Orleans, Louisiana, United States, 70121
Actively Recruiting
6
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
7
Comprehensive Cancer Center of Nevada
Las Vegas, Nevada, United States, 89169
Actively Recruiting
8
Christus St Vincent Regional Medical Center
Santa Fe, New Mexico, United States, 87505
Actively Recruiting
9
START New York
Lake Success, New York, United States, 11042
Actively Recruiting
10
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
11
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 11766
Actively Recruiting
12
University of Pittsburg Medical Center _UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
13
Prisma Health Cancer Institute
Greenville, South Carolina, United States, 29605
Actively Recruiting
14
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
15
Texas Oncology - Central South
Austin, Texas, United States, 78731
Actively Recruiting
16
START San Antonio, LLC.
San Antonio, Texas, United States, 78229
Actively Recruiting
17
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
18
START Mountain Region, LLC.
West Valley City, Utah, United States, 84119
Actively Recruiting
19
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
20
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
21
Changhua Christian Hospital
Chang-hua, Taiwan
Actively Recruiting
22
E-Da Cancer Hospital
Kaohsiung City, Taiwan, 824
Actively Recruiting
23
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Actively Recruiting
24
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Actively Recruiting
25
China Medical University Hospital
Taichung, Taiwan
Actively Recruiting
26
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Actively Recruiting
27
Chi Mei Hospital
Tainan, Taiwan, 736
Actively Recruiting
28
National Taiwan University Hospital
Taipei, Taiwan, 10002
Actively Recruiting
29
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Actively Recruiting
30
Mackay Memorial Hospital
Taipei, Taiwan
Actively Recruiting
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Research Team
C
Clinical Operations Team
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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