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NOT YET RECRUITING
NCT07593144
PHASE1

A Single-Arm, Open-Label Phase Ia/Ib Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of FS-207 in Patients With Advanced Solid Tumors With High Microsatellite Instability (MSI-H)

Sponsor: Foresight Therapeutics (Hefei) Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a Phase Ia/Ib clinical study of FS-207, an investigational oral tablet, in patients with advanced solid tumors that are microsatellite instability-high, also called MSI-H. MSI-H tumors have specific changes in DNA repair pathways and may depend on the WRN protein to survive. FS-207 is designed to inhibit WRN. The main purpose of this study is to evaluate the safety and tolerability of FS-207 and to understand how the drug moves through the body. The study will also look for early signs of anti-tumor activity. This study has two parts. In the first part, called dose escalation, small groups of patients will receive increasing dose levels of FS-207 to help identify a safe and appropriate dose for further study. In the second part, called dose expansion, additional patients with selected MSI-H advanced solid tumors will receive FS-207 at dose level(s) chosen based on the earlier safety and clinical data. Participants will take FS-207 orally once daily. Study doctors will monitor participants closely through physical examinations, blood and urine tests, electrocardiograms, heart function tests, imaging scans, and blood samples for pharmacokinetic testing. Tumor assessments will be performed regularly to evaluate whether the cancer has responded to treatment, remained stable, or progressed. This is an open-label study, which means that both the participants and study doctors will know that FS-207 is being given. There is no placebo group in this study.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

156

Start Date

2026-05-15

Completion Date

2029-05-15

Last Updated

2026-06-03

Healthy Volunteers

No

Interventions

DRUG

FS-207

FS-207 will be administered orally

Locations (17)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Jilin Cancer Hospital

Changchun, Jilin, China

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Cancer Hospital of Shandong First Medical School

Jinan, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

West China Hospital,Sichuan University

Chengdu, Sichuan, China

the Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Peking University Cancer Hospital

Beijing, China

Peking Union Medical College Hospital

Beijing, China

Shanghai Tenth People's Hospital

Shanghai, China