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/41423415/Actively Recruiting
Led by Coherus Oncology, Inc. · Updated on 2026-07-15
154
Participants Needed
30
Research Sites
N/A
Total Duration
Researchers are evaluating the safety and preliminary effectiveness of a drug called CHS-114 combined with toripalimab and possibly other standard treatments in adults with advanced or metastatic solid tumors. This Phase 1B study focuses on participants with specific types of solid tumors, including gastric, esophageal, and colorectal cancers, to understand how these treatments work together in this serious condition. Participants receive CHS-114 through an intravenous infusion along with toripalimab every three weeks. Some groups may also receive additional drugs like 5 fluorouracil and cisplatin. The study includes several treatment groups with different doses and combinations to compare effects and safety. Treatment and monitoring may continue for up to about 2.25 years. During the study, participants undergo regular assessments to monitor side effects, tumor response, and drug levels in the blood. Researchers track treatment-emergent adverse events for up to 90 days after the last dose, and tumor response and progression are evaluated using standard criteria. Participants provide tumor tissue samples and undergo safety monitoring throughout the trial, which may last until early 2028.
CONDITIONS
A Study of CHS-114 (Tagmokitug) in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors
C
Clinical Operations Team
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Coherus Oncology, Inc.
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | CHS‑114 + toripalimab + chemotherapy (Cohort C) | CHS‑114 (Dose A or B) + toripalimab (Cohorts A/B) | CHS‑114 + toripalimab (Cohort D) |
|---|---|---|---|
| What it is | An investigational combination of CHS‑114 plus toripalimab with added chemotherapy (5‑fluorouracil and cisplatin) being tested in first‑line esophageal squamous cell carcinoma (Cohort C). | An investigational regimen of CHS‑114 (two dose levels) plus toripalimab in second‑line gastric/GEJ/esophageal adenocarcinoma (Cohort A) and second‑line ESCC (Cohort B). | An investigational CHS‑114 plus toripalimab regimen being tested in later‑line (4L+) colorectal carcinoma participants (Cohort D). |
| Role in trial | Evaluational treatment arm combining immunotherapy with chemotherapy. | Evaluational immunotherapy dose‑level arms without chemotherapy. | Evaluational immunotherapy arm in heavily pretreated colorectal cancer. |
| Primary use | Test whether adding chemotherapy enhances CHS‑114 plus toripalimab activity in first‑line ESCC. | Evaluate safety and preliminary activity of two dose levels of CHS‑114 plus toripalimab in second‑line gastric or esophageal tumors. | Assess investigational immunotherapy in advanced colorectal carcinoma when standard therapies are exhausted. |
| How it is given or performed | Administered intravenous CHS‑114 and toripalimab along with 5‑FU and cisplatin per protocol. | Administered intravenous CHS‑114 at one of two doses plus toripalimab, schedule per protocol. | Administered intravenous CHS‑114 with toripalimab, schedule defined in protocol. |
| Evidence status | Preclinical and early clinical biomarker data show selective depletion of CCR8+ intratumoral Tregs and immune activation with CHS‑114 plus PD‑1 inhibition. | Early phase data support proof of mechanism—tumor immune remodeling noted with CHS‑114 monotherapy and combination in preclinical and Phase 1 settings. | Proof of mechanism demonstrated; however, antitumor efficacy in colorectal carcinoma remains investigational. |
| Important limitations | Efficacy and safety of adding chemotherapy are not yet established; exploratory early‑phase trial. | Dose‑finding regimens; optimal dose and efficacy remain undetermined. | Conducted in heavily pretreated patients where standard options are exhausted; efficacy uncertain. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 2.25 years
Participants receive CHS-114 combined with toripalimab and possibly other standard treatments through intravenous infusions every three weeks. Treatment groups vary by drug dose and combination with additional medications like 5 fluorouracil and cisplatin.
Infusions every 3 weeks
Duration - Up to 90 days after last dose
Participants are monitored for safety and treatment effects, including adverse events and tumor response evaluations using standard criteria. Monitoring continues for up to 90 days after the last dose and may extend further for outcome assessments.
Regular assessments
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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Xiaoguang Wang, Varun N Kapoor, Daniel J Chin...
https://pubmed.ncbi.nlm.nih.gov/41423415/Coherus Oncology, Inc.
Lead Sponsor