drugset / Trial / NCT07639450

N-3C01 Monotherapy and Combination With PD-(L)1 Inhibitors in Advanced Solid Tumors

NCT07639450

Phase 1/2 Recruiting 114 enrolled Hefei Xinzhu Biological Technology Co., Ltd.
Non-randomizedSequentialOpen-labelTreatment

Summary

This Phase I/II study evaluates the safety, tolerability, and efficacy of N-3C01 administered subcutaneously, both as monotherapy and in combination with a PD-(L)1 monoclonal antibody, in patients with advanced solid tumors. Phase I involves dose escalation for both monotherapy and combination therapy, while Phase II includes cohort expansion for the combination therapy.

Timeline

Start
2026-06-15
Primary completion
2028-08-31
Completion
2028-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject N-3C01 Unknown Subcutaneous
Subject Pembrolizumab Monoclonal antibody Intravenous

Indications