drugset / Trial / NCT05829057
The IIT Study of Evaluation of P-IL-2 Single Agent and With Anti-PD-1
Phase 1
Unknown
10 enrolled
Zhejiang University
Zcapsule Pharmaceuticals (Shaoxing) Co., Ltd · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
Phase Ia: single-dose escalation study: accelerated titration combined with traditional "3+3" dose. Sample size is correlated with the DLT occurring in each dose group. 4 dose groups are expected; the first dose group is the accelerated titration group, which includes only 1 subject; subsequent dose groups are in traditional "3+3" dose increments, with 3-6 subjects in each group; a total of 10-19 subjects are expected in all dose groups. If the DLT is still not present in the highest dose ,the safety monitoring committee(SMC) to determine if it is necessary to continue incrementally to a higher dose.
Timeline
- Start
- 2023-05-23
- Primary completion
- 2024-12-31
- Completion
- 2025-06-21