drugset / Trial / NCT05417750
A Phase I Study of GC101 TIL in Advanced Solid Tumors
Non-randomizedParallel-groupOpen-labelTreatment
Summary
20-60 participants are expected to be enrolled for the Phase I clinical trial which is further divided into two parts: a "3+3" dose escalation study and an expanded enrollment study. The Phase I clinical trial is expected to be finished in 36 months. To be specific, the dose escalation study plans to include patients with advanced malignant solid tumors with clear pathological diagnosis, including melanoma, cervical cancer, head and neck squamous cell tumors, non-small cell lung cancer and breast cancer, etc.; while the expanded enrollment study plans to include those with melanoma, cervical cancer, and head and neck squamous cell tumors.
Timeline
- Start
- 2022-10-12
- Primary completion
- 2025-04-30
- Completion
- 2025-10-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GC101 TIL | Cell therapy | — | — |
| Background | Sintilimab | Monoclonal antibody | — | — |