Study of SIM0508 Alone and in Combination in Patients With Advanced Solid Tumors

Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
Study ID
NCT06686745
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

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

Interventions

  • SIM0508 Tablets — DRUG
    Every 28 days is one cycle. Multiple dose levels of SIM0508 will be explored in dose escalation, and determine the maximum tolerated dose.
  • SIM0508 in combination with olaparib — DRUG
    Every 28 days is one cycle.Multiple dose levels of SIM0508 and olaparib will be explored in dose escalation, and determine the maximum tolerated dose.
  • SIM0508 in combination with olaparib — DRUG
    Every 28 days is one cycle.Patients will be administered a potential recommended dose of SIM0508 combination with olaparib established from SIM0508 combination dose escalation.

Study Details

This is a multicenter, open-label, first-in-human study to evaluate the safety,efficacy, and PK/PD characteristics of SIM0508 as a single agent and in combination with olaparib in participants with locally advanced/metastatic solid tumors.

Key Dates

Start date
Dec 6, 2024
Status verified
Jan 2025
Primary completion
Jun 30, 2027
Completion
Dec 30, 2028

Study Design

Enrollment
130 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: SIM0508 mono dose escalation
    Every 28 days is one cycle. Multiple dose levels of SIM0508 will be explored in dose escalation, and determine the maximum tolerated dose.
  • Experimental: SIM0508 combination dose escalation
    Every 28 days is one cycle.Multiple dose levels of SIM0508 and olaparib will be explored in dose escalation, and determine the maximum tolerated dose.
  • Experimental: SIM0508 in combination with olaparib
    Every 28 days is one cycle.Patients will be administered a potential recommended dose of SIM0508 combination with olaparib established from SIM0508 combination dose escalation.

Primary Outcome Measure

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

Central Contacts

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