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Advanced Solid TumorPhase 1NCT05635643

Study of CHS-114 in Participants With Advanced Solid Tumors

A Phase 1 study testing CHS-114 and toripalimab in people with Advanced Solid Tumor and Head and Neck Squamous Cell Carcinoma, run by Coherus Oncology, Inc. at 12 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
CHS-114 and toripalimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
12 sitesUnited States
Study dates
15 Dec 2022to 1 Jan 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • University of Michigan

    Ann Arbor, Michigan, 48104

  • Emory Winship Cancer Institute

    Atlanta, Georgia, 30308

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • Barbara Ann Karmanos Cancer Institute - Karmanos Cancer Center

    Detroit, Michigan, 48201

  • University of Louisville

    Louisville, Kentucky, 40202

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37203

  • Stanford Cancer Center

    Palo Alto, California, 94305

  • START- San Antonio

    San Antonio, Texas, 78229

  • University of Washington/Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • Washington University

    St Louis, Missouri, 63110

  • START Mountain

    West Valley City, Utah, 84119

Other trials in United States

About this study

Official title: 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.

Read the 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.
Being tested
CHS-114, toripalimab
Keywords
metastatic solid tumors, advanced solid tumors, Phase 1, SRF114, CCR8, safety, efficacy, immunotherapy, cancer, immuno-oncology, CHS-114
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CHS-114Drug

    CHS-114

  • toripalimabDrug

    Also called Loqtorzi

    toripalimab-tpzi

Study groups in NCT05635643
Study groupRoleWhat they receive
Arm 1a: CHS-114 Dose EscalationExperimentalArm 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).
Receives: Drug: CHS-114
Arm 1b: CHS-114 Dose ExpansionExperimentalArm 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).
Receives: Drug: CHS-114
Arm 2: CHS-114 + toripalimab Dose EscalationExperimentalArm 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.
Receives: Drug: CHS-114; Drug: toripalimab
Arm 3: CHS-114 + toripalimab Dose ExpansionExperimentalArm 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.
Receives: Drug: CHS-114; Drug: toripalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. [Arms 1a, 1b, and 2] Rate of Dose Limiting Toxicity (DLT)

    Evaluation of rate of DLT of CHS-114 as a monotherapy, or in combination with toripalimab

    Measured: Assessed during first 21 days of treatment

  2. [Arm 2] Summary of adverse events (AEs) based on treatment emergent AEs (TEAEs), anti-drug antibodies (ADA), and laboratory values.

    Safety and tolerability of CHS-114 in combination with toripalimab,

    Measured: Up to 24 months

  3. [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.

    Safety and tolerability of CHS-114 in combination with toripalimab

    Measured: Up to 24 months

Secondary outcomes (8)

  1. [Arms 1a and 1b] Summary of AEs based on TEAEs.

    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.

    Measured: Up to 24 months

  2. [Arms 1a and 1b] ADAs to CHS-114

    Serum will be collected and assessed for the development of ADAs to CHS-114

    Measured: Up to 24 months

  3. [Arms 1a, 1b, 2, and 3] PK of CHS-114

    Serum concentrations of CHS-114 will be collected and analyzed to evaluate the PK of CHS-114 and in Arms 2 and 3, toripalimab.

    Measured: Up to 24 months

  4. [Arms 1a, 1b, 2, and 3] Confirmed objective response rate (ORR)

    Confirmed objective response rate (ORR) based on RECIST v1.1

    Measured: Up to 24 months

  5. [Arms 1a, 1b, 2, and 3] Duration of response (DoR)

    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.

    Measured: Up to 24 months

  6. [Arms 1a, 1b, 2, and 3] Disease control rate (DCR)

    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.

    Measured: Up to 24 months

  7. [Arms 1a, 1b, 2, and 3] Progression-free survival (PFS)

    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.

    Measured: Up to 24 months

  8. [Arms 1a, 1b, 2, and 3] Changes in FOXP3 levels in participants undergoing pretreatment and on-treatment tumor biopsies

    Cellular FOX3P expression within the tumor will be collected and analyzed in participants who are undergoing pretreatment and on-treatment biopsies

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2022
  2. Study start15 Dec 2022
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
87 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05635643
Sponsor's protocol ID
SRF114-101
Status last verified
Aug 2026
First submitted
14 Nov 2022
Last updated
12 Aug 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang X, Kapoor VN, Chin DJ, Klakamp SL, Baruffaldi F, Mohan JF, Haines R, Dulak A, Panduro M, Ren Y, Masia R, Hill JA, LaVallee TM, Rajasekaran N. CHS-114: An Afucosylated Anti-CCR8 Monoclonal Antibody that Selectively Depletes Intratumoral Treg Cells and Induces Antitumor Immune Responses. Mol Cancer Ther. 2026 May 4;25(5):685-700. doi: 10.1158/1535-7163.MCT-25-0367.

    PubMed 41423415

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CHS-114 and toripalimab in people with Advanced Solid Tumor and Head and Neck Squamous Cell Carcinoma, run by Coherus Oncology, Inc. at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

[Arms 1a, 1b, and 2] Rate of Dose Limiting Toxicity (DLT) (time frame: Assessed during first 21 days of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05635643, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.

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