Study of CHS-114 in Participants With Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Solid Tumor; Head and Neck Squamous Cell Carcinoma
• Interventions: Drug: CHS-114; Drug: toripaliamab

• Registration Number: NCT05635643
• Lead Sponsor: Coherus Biosciences, Inc.

Brief Summary

This is a Phase 1, open-label, first-in-human, dose-escalation and expansion study of SRF114, a monoclonal antibody that targets CCR8, as a monotherapy in patients with solid tumors.

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:
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-11-14
• Study First Submitted QC: 2022-11-22
• Study First Posted: 2022-12-02
• Study Start: 2022-12-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-20
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1a: CHS-114 Dose Escalation	CHS-114	Arm 1 monotherapy dose escalation portion of the study will evaluate the safety, tolerability, pharmacokinetics, 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).
Arm 1b: CHS-114 Dose Expansion	CHS-114	Arm 1b monotherapy expansion will evaluate the safety, tolerability, pharmacokinetics, 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).
Arm 2: CHS-114 + toripalimab Dose Expansion	CHS-114	Arm 2 combination dose expansion will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CHS-114 in combination with toripalimab at 2 dose recommended Phase 2 dose \[RDE\] levels in up to 6 participants in each dose level with Head and Neck Squamous Cell Carcinoma (HNSCC).
Arm 2: CHS-114 + toripalimab Dose Expansion	toripaliamab	Arm 2 combination dose expansion will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CHS-114 in combination with toripalimab at 2 dose recommended Phase 2 dose \[RDE\] levels in up to 6 participants in each dose level with Head and Neck Squamous Cell Carcinoma (HNSCC).

Primary Outcome Measures

Name	Time	Method
[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

Secondary Outcome Measures

Name	Time	Method
[Arms 1a and 1b] Summary of adverse events (AEs) based on treatment emergent AEs (TEAEs).	Up to 24 months	Safety and tolerability of CHS-114 as monotherapy, and in combination with toripalimab, will be assessed by summarizing adverse events (AEs) and will be based on treatment-emergent adverse events (TEAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher.
[Arms 1a, 1b, and 2] Progression-free survival (PFS)	Up to 24 months	Progression-free survival (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.
[Arms 1a and 1b] Changes in FOXP3 levels in participants undergoing pretreatment and on-treatment tumor biopsies	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
Anti-drug Antibodies (ADAs) to CHS-114	Up to 24 months	Serum will be collected and assessed for the development of ADAs to CHS-114
[Arms 1a, 1b, and 2] Disease control rate (DCR)	Up to 24 months	Disease control rate (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.
[Arms 1a, 1b, and 2] Pharmacokinetics (PK) of CHS-114	Up to 24 months	Serum concentrations of CHS-114 will be collected and analyzed to evaluate the PK of CHS-114 and in Arm 2 toripalimab.
[Arms 1a, 1b, and 2] Confirmed objective response rate (ORR)	Up to 24 months	Confirmed objective response rate (ORR) based on RECIST v1.1
[Arms 1a, 1b, and 2] Duration of response (DoR)	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.

Trial Locations

Locations (11)

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States

Stanford Cancer Center; 🇺🇸 Palo Alto, California, United States

Emory Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Barbara Ann Karmanos Cancer Institute - Karmanos Cancer Center; 🇺🇸 Detroit, Michigan, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

START- San Antonio; 🇺🇸 San Antonio, Texas, United States

START Mountain; 🇺🇸 West Valley City, Utah, United States

University of Washington/Fred Hutchinson Cancer Center; 🇺🇸 Seattle, Washington, United States