Study of CHS-114 in Participants With Advanced Solid Tumors

March 17, 2026 updated by: Coherus Oncology, Inc.

A Phase 1 Study of CHS-114 in Participants With Advanced Solid Tumors

This is a Phase 1, open-label, first-in-human, dose-escalation and expansion study of CHS-114, a monoclonal antibody that targets CCR8, as a monotherapy in patients with solid tumors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 1, open-label, first-in-human, dose-escalation and expansion study of CHS-114, a monoclonal antibody that targets CCR8, as a monotherapy in participants with advanced solid tumors, that will be conducted in 3 parts:

  • Arm 1a: CHS-114 monotherapy dose-escalation portion of the study will enroll approximately 25 participants with advanced solid tumors.
  • Arm 1b: CHS-114 monotherapy expansion cohort(s) will evaluate the safety, efficacy, tolerability, pharmacokinetics, and pharmacodynamics of CHS-114 in indication specific cohort(s). Up to approximately 10 participants will be enrolled.
  • Arm 2: CHS-114 + toripalimab combination dose-escalation portion of the study will evaluate the safety, efficacy, tolerability, pharmacokinetics, and pharmacodynamics of CHS-114 in combination with toripalimab in indication specific cohort(s). Up to approximately 6-12 participants will be enrolled.
  • Arm 3: CHS-114 + toripalimab combination dose-expansion portion of the study will evaluate the safety, efficacy, tolerability, pharmacokinetics, and pharmacodynamics of CHS-114 in combination with toripalimab in indication specific cohort(s). Up to approximately 40 participants will be randomized to two dosing arms.

Study Type

Interventional

Enrollment (Estimated)

87

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: MD at Coherus, MD
  • Phone Number: 1-800-794-5434

Study Contact Backup

Study Locations

  • United States
    • California
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Hoag Memorial Hospital
        • Principal Investigator:
          • Alain Mita, MD
        • Contact:
      • Oxnard, California, United States, 93030
        • Recruiting
        • FOMAT Medical Research
        • Contact:
        • Principal Investigator:
          • Nawazish Khan, MD
      • Palo Alto, California, United States, 94305
        • Recruiting
        • Stanford Cancer Center
        • Principal Investigator:
          • A. Dimitrios Colevas, MD
        • Contact:
    • Florida
      • Orlando, Florida, United States, 32827
        • Recruiting
        • SCRI Lake Nona DDU (FL Cancer Specialists)
        • Contact:
        • Principal Investigator:
          • Cesar A Perez-Batista, MD
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory Winship Cancer Institute
        • Principal Investigator:
          • Nabil F Saba, MD
        • Contact:
    • Illinois
      • Hinsdale, Illinois, United States, 60521
        • Recruiting
        • Hope & Healing Cancer Services
        • Principal Investigator:
          • Srilata Gundala, MD
        • Contact:
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University of Louisville
        • Principal Investigator:
          • Rebecca Redman, MD
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland Greenebaum Comprehensive Cancer Center
        • Principal Investigator:
          • Ranee Mehra, MD
        • Contact:
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Recruiting
        • University of Michigan
        • Principal Investigator:
          • Francis Worden, MD
        • Contact:
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Barbara Ann Karmanos Cancer Institute - Karmanos Cancer Center
        • Contact:
        • Principal Investigator:
          • Ammar Sukari, MD
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
        • Principal Investigator:
          • Douglas Adkins, MD
        • Contact:
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati
        • Principal Investigator:
          • Trisha Wise-Draper, MD
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Vanderbilt-Ingram Cancer Center
        • Contact:
          • Cancer Center Trials Office
          • Phone Number: 800-811-8480
          • Email: cip@vumc.org
        • Principal Investigator:
          • Jennifer H Choe, MD, PhD
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • START- San Antonio
        • Principal Investigator:
          • Amita Patnaik, MD
        • Contact:
    • Utah
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • University of Washington/Fred Hutchinson Cancer Center
        • Contact:
        • Principal Investigator:
          • Christina Rodriguez, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Key Inclusion Criteria - Arms 1a, 1b, 2, and 3

  • 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.

Additional Inclusion Criteria - Arms 1b and 2 only

  • 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.

Additional Inclusion Criteria - Arm 3 only

  • 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.

Key Exclusion Criteria - Arms 1a, 1b, 2, and 3

  • 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.

Additional Exclusion Criteria - Arms 1b and 2 only

  • 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).

Additional Exclusion Criteria - Arm 3

• Received ≥ 2 prior systemic regimens for advanced/metastatic disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1a: CHS-114 Dose Escalation
Arm 1 monotherapy dose escalation portion of the study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of CHS-114 as monotherapy in up to 25 participants with advanced solid tumors, to determine the recommended dose for expansion (RDE).
Drug: CHS-114
CHS-114
Experimental: Arm 1b: CHS-114 Dose Expansion
Arm 1b monotherapy expansion will evaluate the safety, tolerability, PK, pharmacodynamics, and efficacy of CHS-114 monotherapy at 2 dose levels (potential recommended dose for expansion RDE in up to 5 participants in each dose level with Head and Neck Squamous Cell Carcinoma (HNSCC).
Drug: CHS-114
CHS-114
Experimental: Arm 2: CHS-114 + toripalimab Dose Escalation
Arm 2 dose escalation will evaluate the safety, tolerability, PK, pharmacodynamics, and efficacy of CHS-114 in combination with toripalimab at 2 RDE levels in up to 6 participants in each dose level with HNSCC.
Drug: CHS-114
CHS-114
Drug: toripalimab
toripalimab-tpzi
Other Names:
  • Loqtorzi
Experimental: Arm 3: CHS-114 + toripalimab Dose Expansion
Arm 3 dose expansion will evaluate the safety, tolerability, PK, pharmacodynamics, and efficacy of CHS-114 in combination with toripalimab at 2 RDE levels in up to 20 participants in each dose level with HNSCC.
Drug: CHS-114
CHS-114
Drug: toripalimab
toripalimab-tpzi
Other Names:
  • Loqtorzi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
[Arms 1a, 1b, and 2] Rate of Dose Limiting Toxicity (DLT)
Time Frame: Assessed during first 21 days of treatment
Evaluation of rate of DLT of CHS-114 as a monotherapy, or in combination with toripalimab
Assessed during first 21 days of treatment
[Arm 2] Summary of adverse events (AEs) based on treatment emergent AEs (TEAEs), anti-drug antibodies (ADA), and laboratory values.
Time Frame: Up to 24 months
Safety and tolerability of CHS-114 in combination with toripalimab,
Up to 24 months
[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.
Time Frame: Up to 24 months
Safety and tolerability of CHS-114 in combination with toripalimab
Up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
[Arms 1a and 1b] Summary of AEs based on TEAEs.
Time Frame: Up to 24 months
Safety and tolerability of CHS-114 as monotherapy will be assessed by summarizing AEs and will be based on TEAEs as assessed by CTCAE v5.0 or higher.
Up to 24 months
[Arms 1a and 1b] ADAs to CHS-114
Time Frame: Up to 24 months
Serum will be collected and assessed for the development of ADAs to CHS-114
Up to 24 months
[Arms 1a, 1b, 2, and 3] PK of CHS-114
Time Frame: Up to 24 months
Serum concentrations of CHS-114 will be collected and analyzed to evaluate the PK of CHS-114 and in Arms 2 and 3, toripalimab.
Up to 24 months
[Arms 1a, 1b, 2, and 3] Confirmed objective response rate (ORR)
Time Frame: Up to 24 months
Confirmed objective response rate (ORR) based on RECIST v1.1
Up to 24 months
[Arms 1a, 1b, 2, and 3] Duration of response (DoR)
Time Frame: Up to 24 months
Duration of response (DoR) based on RECIST v1.1. DoR is defined as the time from the first documented response (CR or PR) to documented disease progression as determined by RECIST v1.1 or death.
Up to 24 months
[Arms 1a, 1b, 2, and 3] Disease control rate (DCR)
Time Frame: Up to 24 months
DCR based on RECIST v1.1. DCR is defined as the percentage of patients with CR, partial PR, or stable disease lasting a minimum of 12 weeks.
Up to 24 months
[Arms 1a, 1b, 2, and 3] Progression-free survival (PFS)
Time Frame: Up to 24 months
PFS based on RECIST v1.1. PFS is defined as the time from the first treatment on study with study drug to documented disease progression as determined by RECIST v1.1 or death.
Up to 24 months
[Arms 1a, 1b, 2, and 3] Changes in FOXP3 levels in participants undergoing pretreatment and on-treatment tumor biopsies
Time Frame: Up to 24 months
Cellular FOX3P expression within the tumor will be collected and analyzed in participants who are undergoing pretreatment and on-treatment biopsies
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coherus Oncology, Inc.

Investigators

  • Study Director: Koho Izuka, MD, Coherus BioSciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2022

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 14, 2022

First Submitted That Met QC Criteria

November 22, 2022

First Posted (Actual)

December 2, 2022

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRF114-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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