Study of SIM0501 Alone and in Combination in Patients With Advanced Solid Tumors - Trial NCT06331559
Access comprehensive clinical trial information for NCT06331559 through Pure Global AI's free database. This Phase 1 trial is sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd. and is currently Recruiting. The study focuses on Advanced Solid Tumors. Target enrollment is 176 participants.
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Study Focus
Sponsor & Location
Jiangsu Simcere Pharmaceutical Co., Ltd.
Timeline & Enrollment
Phase 1
Mar 19, 2024
Dec 31, 2027
Primary Outcome
Dose-limiting toxicity (DLT),Adverse events will be evaluated according to the CTCAE v5.0
Summary
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06331559
Non-Device Trial