drugset / Trial / NCT06081907
The Efficacy and Safety of IBI363 in Solid Tumors
Phase 1/2
Recruiting
430 enrolled
Hunan Province Tumor Hospital
Xiangya Hospital of Central South University · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The study is a prospective multi-cohort clinical study. The study is divided into two phases, Phase Ia and Phase Ib. In Phase Ia, a dose escalation portion was conducted using a 3+3 dose-escalation design, with a preference for enrolling subjects with advanced non-small cell lung cancer and melanoma. Phase Ib represents the cohort expansion phase, comprising seven cohorts.
Timeline
- Start
- 2023-12-25
- Primary completion
- 2026-12-01
- Completion
- 2028-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IBI363 | Protein / enzyme biologic | 600 ug/kg | — |
| Subject | IBI363 | Protein / enzyme biologic | 1 mg/kg | — |
| Subject | IBI363 | Protein / enzyme biologic | 1.5 mg/kg | — |