Study of CHS-114 with Toripalimab for Advanced Solid Tumors
This study is looking at the safety of a new treatment called CHS-114. It's being tested in combination with toripalimab and/or other standard cancer treatments for people with advanced or metastatic (spread to other parts of the body) solid tumors. The main goal is to see how safe these combinations are and to get an early idea of how well they work. You might be able to join if you are 18 or older, have a measurable tumor, and have recovered from any previous treatments. This study is currently unclear about its recruitment status and plans to enroll about 154 participants.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 154 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be monitored for treatment-emergent adverse events (side effects) from the first dose until 90 days after the last dose, for up to approximately 2.25 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06657144
A Study of CHS-114 (Tagmokitug) in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors
Recruiting
PHASE1Ages 18+InterventionalTreatmentCoherus Oncology, Inc.
~154 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:CHS-114Toripalimab5 FluorouracilCisplatin
At a glance
Recruiting sites
28 of 30 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured over From first dose of study drug until 90 days after the last dose of study drug (up to approximately 2.25 years)
Conditions
Where it's being run
30 sites across 16 statesTaiwan10
New York3
Texas2
Utah2
Virginia2
Arizona1
California1
Colorado1
Study leadership
- Study Director · STUDY_DIRECTOR · Coherus Oncology
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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).
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.
Exclusion
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.
Known allergies to 5-FU or cisplatin.
What this trial measures
- 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)