Study of SIM0501 Alone and in Combination in Patients With Advanced Solid Tumors

Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
Study ID
NCT06331559
Phase
PHASE1
Status
Terminated

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SIM0501 Tablets — DRUG
    Every 28 days is one cycle. Multiple dose levels of SIM0501 will be explored in dose escalation, and determine the maximum tolerated dose.
  • SIM0501 Tablets — DRUG
    Every 28 days is one cycle.Patients will be administered a potential recommended dose of SIM0501 established from SIM0501 mono dose escalation.
  • SIM0501 in combination with olaparib — DRUG
    Every 28 days is one cycle.Multiple dose levels of SIM0501 and olaparib will be explored in dose escalation, and determine the maximum tolerated dose.
  • SIM0501 in combination with olaparib — DRUG
    Every 28 days is one cycle.Patients will be administered a potential recommended dose of SIM0501 combination with olaparib established from SIM0501 combination dose escalation.

Study Details

This is an open-label, multicenter Phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0501 in participants with advanced solid tumors. The trial consists two parts, Part 1 for SIM0501 monotherapy and Part 2 for SIM0501 in combination with olaparib. In both parts, SIM0501 with/without olaparib will be administered until disease progression or the investigator determines that continuation of the study drug would not benefit, or there is intolerable toxicity, or the participant or legal representative voluntarily requests withdrawal, or the trial is terminated.

Key Dates

Start date
Mar 19, 2024
Status verified
Feb 2026
Primary completion
Sep 17, 2025
Completion
Sep 17, 2025

Study Design

Enrollment
13 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: SIM0501 mono dose escalation
  • Experimental: SIM0501 mono dose optimization
  • Experimental: SIM0501 combination dose escalation
  • Experimental: SIM0501 combination dose optimization

Primary Outcome Measure

Dose-limiting toxicity (DLT) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]

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