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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.

About this trial

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).

Eligibility criteria

Qualifiers

1. Subjects aged 18 to 75 years (inclusive).

2. Patients with advanced solid tumors that are unresectable or metastatic and confirmed by histology or cytology.

3. At least one measurable lesion, as defined by RECIST 1.1 criteria.

4. ECOG performance status of 0 or 1.

Disqualifiers

1. Previous use of antibody-conjugated drugs with similar loading agents for treatment.

2. Previous anti-tumor treatment drugs were not adequately removed.

3. Active leptomeningeal disease or uncontrolled CNS metastasis.

4. Having a history of severe or uncontrolled cardiovascular or cerebrovascular diseases.

Trial design

Treatments tested in this trial

  • sirolimus (albumin-bound)
  • DP303c
  • SYS6043
  • SYS6002
  • SYS6010

Treatment groups

444 Participants
are divided into 4 treatment groups