Actively Recruiting
A Study of CHS-114 (Tagmokitug) in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors
Led by Coherus Oncology, Inc. · Updated on 2026-04-06
154
Participants Needed
30
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of CHS-114 (Tagmokitug) in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least one measurable tumor lesion based on RECIST v1.1
- Acute effects of prior therapies resolved to baseline or Grade 1 per NCI-CTCAE v5.0
- For Cohort A: Unresectable, locally advanced or metastatic HER2-negative, MSS/pMMR gastric, gastro-esophageal junction, or esophageal adenocarcinoma
- Progression after first line systemic therapy including platinum and fluoropyrimidine with or without anti-PD-1/PD-L1 therapy for Cohort A
- Consent to provide tumor tissue samples (baseline and on-treatment) for Cohort A
- For Cohort B: Unresectable, locally advanced or metastatic esophageal squamous cell carcinoma
- Progression after first line systemic therapy including platinum and fluoropyrimidine or paclitaxel with or without anti-PD-1/PD-L1 or anti-CTLA-4 therapies for Cohort B
- Consent to provide results from prior PD-L1 IHC assay and archival tumor tissue for Cohort B
- For Cohort C: Unresectable, locally advanced or metastatic esophageal squamous cell carcinoma
- Consent to provide baseline tumor tissue and prior PD-L1 IHC assay results for Cohort C
- Calculated creatinine clearance of 60 mL/min or higher for Cohort C
- For Cohort D: Unresectable advanced or metastatic colorectal adenocarcinoma with documented RAS, BRAF, and MSI/MMR status
- No available therapies with proven clinical benefit in participant's country for Cohort D
- Eligibility includes those with prior oxaliplatin in adjuvant setting who developed metastatic disease within 6 months
- Consent to provide baseline tumor tissue for Cohort D
You will not qualify if you...
- History of other progressing or actively treated malignancy within the past 3 years
- Symptomatic or untreated central nervous system metastases requiring treatment
- Major surgery requiring general anesthesia within 28 days before first study dose or planned surgery during study
- Prior exposure to anti-CCR8 antibody
- History of severe allergic or anaphylactic reaction to monoclonal antibody therapy or any study drug excipient
- Active uncontrolled bacterial, fungal, or viral infections including HBV, HCV, or HIV/AIDS-related illness
- Any condition interfering with study result interpretation as per investigator or sponsor
- For Cohorts A and B: Received 2 or more prior systemic anticancer therapies for advanced/metastatic disease
- For Cohorts A and B: High risk of esophageal fistula by clinical or imaging assessment
- For Cohort C: Received 1 or more prior systemic anticancer therapies for advanced/metastatic disease
- For Cohort C: Progression during or within 6 months after neoadjuvant or perioperative therapy with curative intent
- For Cohort C: High risk of esophageal fistula by clinical or imaging assessment
- For Cohort C: Known dihydropyrimidine dehydrogenase deficiency or thymidine synthase polymorphism increasing 5-FU toxicity risk
- Known allergies to 5-FU or cisplatin
- Other protocol-specified criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Research Team
C
Clinical Operations Team
CONTACT
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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