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
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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

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

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