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Squamous Cell Carcinoma of Head and Neck

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Head and Neck Neoplasms

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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 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 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).

CHS-114

toripaliamab

Hillary O'Kelly

Samuel Williams

Douglas Adkins, MD

Amita Patnaik

Marianne Herden

Justin Call, MD

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.

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.

Study of CHS-114 in Participants With Advanced Solid Tumors

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

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

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.

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

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

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

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.

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.

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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of CHS-114 in Participants With Advanced Solid Tumors	NCT05635643	Advanced Solid ... Head and Neck S...	CHS-114 toripaliamab	18 Years -	Coherus Biosciences, Inc.
Study of CHS-114 in Participants With Advanced Solid Tumors	NCT05635643	Advanced Solid ... Head and Neck S...	CHS-114 toripaliamab	18 Years -	Coherus Biosciences, Inc.

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