NCT07241936

A Study of Sirolimus (Albumin-Bound) in Combination With Different ADCs Treatment of Advanced Solid Tumors

A Phase Ib/II Clinical Trial on the Safety and Efficacy of Sirolimus (Albumin-bound) Combined With Different ADCs in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 444 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study adopts a multi-center, open-label, non-randomized trial design. It plans to enroll patients with Advanced solid tumor. Dose-escalation and PK-expansion studies will be carried out to evaluate the safety, tolerability, and preliminary efficacy of sirolimus (albumin-bound) in combination with Different ADCs (DP303c/SYS6043/SYS6002/SYS6010) in this patient population, and to confirm the recommended phase 2 dose (RP2D).

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	sirolimus (albumin-bound)	intravenous infusion
DRUG	DP303c	intravenous infusion
DRUG	SYS6043	intravenous infusion
DRUG	SYS6002	intravenous infusion
DRUG	SYS6010	intravenous infusion

Timeline

• Start date: 2025-11-13
• Primary completion: 2027-10-30
• Completion: 2028-10-30
• First posted: 2025-11-21
• Last updated: 2025-11-28

Locations

1 site across 1 country: China