Study of SIM0501 Alone and in Combination in Patients With Advanced Solid Tumors
- Disease/Condition
- Advanced Solid Tumors
- Drug/Device/Intervention
- SIM0501 Tablets
- Study type
- Interventional
- Intervention type
- drug
- Primary sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Location
- Jinan, China
- Phase
- Phase 1
- Start date
- Mar 19, 2024
- End date
- Dec 31, 2027
- Enrollment
- 176 participants
Dose-limiting toxicity (DLT),Adverse events will be evaluated according to the CTCAE v5.0
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.
- Registry
- ClinicalTrials.gov
- Trial ID
- NCT06331559
- Type
- Non-Device Trial
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.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.