NCT06686745

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-06
• Primary completion: 2027-06-30
• Completion: 2028-12-30
• First posted: 2024-11-13
• Last updated: 2025-01-07

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated drug study