A Phase 1 Study of CHS-114 in Participants With Advanced Solid Tumors
Coherus Oncology, Inc.
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.
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 en…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Key Inclusion Criteria - Arms 1a, 1b, 2, and 3 * 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 pre…
Interventions
- DrugCHS-114
CHS-114
- Drugtoripalimab
toripalimab-tpzi
Locations (16)
- Hoag Memorial HospitalNewport Beach, California
- FOMAT Medical ResearchOxnard, California
- Stanford Cancer CenterPalo Alto, California
- SCRI Lake Nona DDU (FL Cancer Specialists)Orlando, Florida
- Emory Winship Cancer InstituteAtlanta, Georgia
- Hope & Healing Cancer ServicesHinsdale, Illinois