drugset / Trial / NCT05757492
Study to Evaluate Safety and PK of CHS-006 in Combination With Toripalimab in Patients With Advanced Solid Tumors
Phase 1
Terminated
22 enrolled
Coherus Oncology, Inc.
Medpace, Inc. · collabShanghai Junshi Bioscience Co., Ltd. · collab
RandomizedSequentialOpen-labelTreatment
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 \[HCC\])
Timeline
- Start
- 2023-04-26
- Primary completion
- 2024-07-31
- Completion
- 2024-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | CHS-006 | Unknown | — | Intravenous |
| Comparator | Toripalimab | Monoclonal antibody | — | Intravenous |