NCT05635643

Study of CHS-114 in Participants With Advanced Solid Tumors

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 87 (estimated)
• Sponsor: Coherus Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Advanced Solid Tumor
• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	CHS-114	CHS-114
DRUG	toripalimab	toripalimab-tpzi

Timeline

• Start date: 2022-12-15
• Primary completion: 2026-09-30
• Completion: 2027-01-01
• First posted: 2022-12-02
• Last updated: 2026-03-19

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study