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Study of SIM0508 Alone and in Combination in Patients With Advanced Solid Tumors
Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Summary
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.
Official title: A Phase I, First-in-Human, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0508 Monotherapy and Combination Therapy in Adult Participants With Locally Advanced/Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2024-12-06
Completion Date
2028-12-30
Last Updated
2025-01-07
Healthy Volunteers
No
Conditions
Interventions
SIM0508 Tablets
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
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
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.
Locations (2)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Chongqing Cancer Hospital
Chongqing, China