Study of CHS-114 in Participants With Advanced Solid Tumors
- Conditions
- Advanced Solid TumorHead and Neck Squamous Cell Carcinoma
- Interventions
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 87
Not provided
Not provided
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 (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). Arm 1b: CHS-114 Dose Expansion CHS-114 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). Arm 2: CHS-114 + toripalimab Dose Escalation CHS-114 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. Arm 2: CHS-114 + toripalimab Dose Escalation toripalimab 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. Arm 3: CHS-114 + toripalimab Dose Expansion CHS-114 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. Arm 3: CHS-114 + toripalimab Dose Expansion toripalimab 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.
- Primary Outcome Measures
Name Time Method [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. Up to 24 months Safety and tolerability of CHS-114 in combination with toripalimab
[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
[Arm 2] Summary of adverse events (AEs) based on treatment emergent AEs (TEAEs), anti-drug antibodies (ADA), and laboratory values. Up to 24 months Safety and tolerability of CHS-114 in combination with toripalimab,
- Secondary Outcome Measures
Name Time Method [Arms 1a, 1b, 2, and 3] 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.
[Arms 1a, 1b, 2, and 3] Disease control rate (DCR) 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.
[Arms 1a, 1b, 2, and 3] Progression-free survival (PFS) 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.
[Arms 1a, 1b, 2, and 3] 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
[Arms 1a and 1b] Summary of AEs based on TEAEs. 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.
[Arms 1a and 1b] 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, 2, and 3] 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 Arms 2 and 3, toripalimab.
[Arms 1a, 1b, 2, and 3] Confirmed objective response rate (ORR) Up to 24 months Confirmed objective response rate (ORR) based on RECIST v1.1
Trial Locations
- Locations (14)
FOMAT Medical Research
🇺🇸Oxnard, California, United States
Stanford Cancer Center
🇺🇸Palo Alto, California, United States
SCRI Lake Nona DDU (FL Cancer Specialists)
🇺🇸Orlando, Florida, United States
Emory Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
Hope & Healing Cancer Services
🇺🇸Hinsdale, Illinois, 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
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, 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