Study of CHS-114 for Advanced Solid Tumors
This study is testing a new drug called CHS-114, alone and in combination with toripalimab, for people with advanced solid tumors, including head and neck squamous cell carcinoma. CHS-114 is a monoclonal antibody, which is a type of targeted therapy. The main goal is to understand the safety of CHS-114 and toripalimab, and to see how well they are tolerated. Researchers will also look at side effects and other health changes over time. You may be able to join if you are 18 or older, have an advanced solid tumor that has progressed after standard treatments, and have at least one measurable tumor. The study plans to enroll 87 participants, but its current status is unclear.
- Study design
- This is a Phase 1, open-label (meaning you and your doctors will know what treatment you are receiving), first-in-human study. It will involve dose-escalation and expansion, with approximately 87 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for up to 24 months after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05635643
Study of CHS-114 in Participants With Advanced Solid Tumors
Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatmentCoherus Oncology, Inc.
~87 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:CHS-114toripalimab
At a glance
Recruiting sites
0 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
[Arms 1a, 1b, and 2] Rate of Dose Limiting Toxicity (DLT)
Measured over Assessed during first 21 days of treatment
+2 more outcomes measured
Conditions
Where it's being run
12 sites across 11 statesMichigan2
California1
Georgia1
Kentucky1
Maryland1
Missouri1
Ohio1
Tennessee1
Study leadership
- Study Director · STUDY_DIRECTOR · Coherus Oncology
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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
Participants must be ≥ 18 years of age.
For Arm 1a only, locally advanced or metastatic (Stage IV) solid tumor that has progressed during or after standard therapy and for whom no available therapies are appropriate (based on the judgment of the Investigator).
At least 1 measurable lesion per RECIST 1.1.
Lesions previously treated with radiation or other forms of locoregional therapy must show radiographic evidence of disease progression to be used as a target lesion.
For Arms 1a, 1b, and 2 only, washout period from the last dose of previous anticancer therapy (chemotherapy, biologic, or other investigational agent) to the initiation of study drug must be \> 5 times the half-life of the agent or \> 21 days (whichever is shorter).
Resolution of non-immune-related AEs secondary to prior anticancer therapy (excluding alopecia and peripheral neuropathy) to ≤ Grade 1 per NCI-CTCAE version 5.0 or higher, and complete resolution of immune-related AEs secondary to prior checkpoint inhibitor therapy.
Serum creatinine clearance ≥ 30 mL/min per Cockcroft-Gault formula.
Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN if elevated because of liver metastases or documented Gilbert's syndrome).
Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) \< 2.5 × ULN or \< 5 × ULN for patients with known liver metastases.
Adequate hematologic function, defined as absolute neutrophil count ≥ 1.0 × 10\^9/L, hemoglobin ≥ 8.0 g/dL, and platelet count ≥ 75 × 10\^9/L.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Ejection fraction ≥ 50%, as measured by echocardiogram, multigated acquisition scan, nuclear stress test, or equivalent modality.
Willingness of male and female patients who are not surgically sterile or postmenopausal to use medically acceptable methods of birth control for the duration of the study treatment period, including 90 days after the last dose of CHS-114, 4 months after the last dose of toripalimab; male patients must refrain from donating sperm during this period. Sexually active men, and women using oral contraceptive pills, should also use barrier contraception. Azoospermic male patients and women of childbearing potential who are continuously not heterosexually active are exempt from contraceptive requirements.
Histologically or cytologically confirmed advanced or metastatic HNSCC that has progressed during or after a platinum-based chemotherapy and/or a programmed cell death receptor (PD)-1 or PD ligand 1 (PD-L1) targeting agent (separately or in combination therapy).
Metastatic or locoregionally recurrent HNSCC malignancy that is incurable by surgery or radiotherapy.
Arm 1b only, participants must have tumor tissue that is accessible for pretreatment and on-treatment tumor biopsy in the opinion of the Investigator and be willing and consent to undergo pretreatment and on-treatment biopsies per protocol.
Histologically or cytologically confirmed locally advanced or metastatic HNSCC (primary tumor location of oral cavity, oropharynx, hypopharynx, or larynx). Participants may not have a primary tumor site of nasopharynx (any histology).
Participants should have been treated with anti-PD-1/PD-L1-directed systemic therapy for incurable recurrent, advanced, or metastatic disease and experienced progressive disease. targeting agent (separately or in combination therapy).
Metastatic or locoregionally recurrent HNSCC malignancy that is incurable by surgery or radiotherapy.
Consent to provide HPV status assessed by p16 and results from baseline PD-L1 IHC assay score.
Consent to provide tumor tissue samples is required for enrollment.
Exclusion
Previously received an anti-CCR8 antibody or anti-CCR8 targeted therapy.
History of Grade 4 allergic or anaphylactic reaction to any monoclonal antibody therapy or any excipient in the study drugs.
Major surgery within 4 weeks prior to Screening.
Unstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition including pneumonitis and/or interstitial lung disease, uncontrolled diabetes, symptomatic fistula) or any important medical illness or abnormal laboratory finding that would, in the Investigator's judgment, increase the risk to the patient associated with his or her participation in the study.
Received \> 4 prior systemic regimens for advanced/metastatic disease.
Nasopharyngeal carcinoma or nasal cavity malignancies other than HNSCC (eg, adenocarcinoma and variants, neuroendocrine tumors, mucosal melanoma).
Receiving chronic anti-coagulation therapy (eg, warfarin, enoxaparin) that cannot be safely discontinued temporarily for the required biopsies (only for patients who provide tumor biopsies).
What this trial measures
- [Arms 1a, 1b, and 2] Rate of Dose Limiting Toxicity (DLT)Assessed during first 21 days of treatment
Evaluation of rate of DLT of CHS-114 as a monotherapy, or in combination with toripalimab
- [Arm 2] Summary of adverse events (AEs) based on treatment emergent AEs (TEAEs), anti-drug antibodies (ADA), and laboratory values.Up to 24 months
Safety and tolerability of CHS-114 in combination with toripalimab,
- [Arm 3] Safety and tolerability of CHS-114 in combination with toripalimab will be assessed by summarizing AEs and will be based on TEAEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher.Up to 24 months
Safety and tolerability of CHS-114 in combination with toripalimab