drugset / Trial / NCT05757492

Study to Evaluate Safety and PK of CHS-006 in Combination With Toripalimab in Patients With Advanced Solid Tumors

NCT05757492

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

EvaluationDrugModalityDoseRoute
Comparator CHS-006 Unknown Intravenous
Comparator Toripalimab Monoclonal antibody Intravenous