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

Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study ID
NCT07241936
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • sirolimus (albumin-bound) — DRUG
    intravenous infusion
  • DP303c — DRUG
    intravenous infusion
  • SYS6043 — DRUG
    intravenous infusion
  • SYS6002 — DRUG
    intravenous infusion
  • SYS6010 — DRUG
    intravenous infusion

Study Details

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).

Key Dates

First listed
Nov 21, 2025
Start date
Nov 13, 2025
Status verified
Nov 2025
Primary completion
Oct 30, 2027
Completion
Oct 30, 2028

Study Design

Enrollment
444 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: sirolimus (albumin-bound)+ DP303c
  • Experimental: sirolimus (albumin-bound)+ SYS6043
  • Experimental: sirolimus (albumin-bound)+ SYS6002
  • Experimental: sirolimus (albumin-bound)+ SYS6010

Primary Outcome Measure

The occurrence and frequency of adverse events (AE) and serious adverse events (SAE) [ Time Frame: Up to approximately 36 weeks after the first participant is enrolled ]

Central Contacts

Related Studies