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RECRUITING
NCT06686745
PHASE1

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

Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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.

DRUG

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