Trials / Terminated
TerminatedNCT05757492
Study to Evaluate Safety and PK of CHS-006 in Combination With Toripalimab in Patients With Advanced Solid Tumors
A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CHS-006, as Monotherapy and in Combination With Toripalimab, in Participants With Advanced Solid Tumors
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Coherus Oncology, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase 1 open-label study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of CHS-006 in combination with toripalimab in 2 phases. Phase 1 (Dose Optimization phase) will explore 2 different dose combinations in participants with advanced/metastatic solid tumors (except pancreatic) and Phase 2 (Indication-specific Expansion phase) will use one selected dose in specific tumor types (non-small cell lung cancer-non squamous \[NSCLC-NS\] and Hepatocellular carcinoma \[HCC\])
Detailed description
The Dose Optimization phase will enroll participants with advanced/metastatic solid tumors (except pancreatic). Up to 20 participants will be randomized into two dosing arms. Two different primary advanced solid tumors have been selected for investigation of antitumor activity in the Indication-specific Expansion phase. Up to 40 participants will be enrolled into each Indication-specific Expansion phase cohort. All participants in both phases will receive CHS-006 in combination with toripalimab intravenously (IV) every 3 weeks (Q3W).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CHS-006 (anti-TIGIT) | Arm A participants will receive CHS-006 administered via IV Q3W. |
| DRUG | toripalimab (anti-PD-1) | Arm B participants will receive toripalimab administered via IV Q3W. |
Timeline
- Start date
- 2023-04-26
- Primary completion
- 2024-07-31
- Completion
- 2024-07-31
- First posted
- 2023-03-07
- Last updated
- 2025-05-01
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05757492. Inclusion in this directory is not an endorsement.