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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
156
FS-207 will be administered orally
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
...and 7 more locations
Number of Participants with a Dose Limiting Toxicity (DLT)
Time frame: Up to 21 days
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to 3 years
Maximum Serum Concentration (Cmax) of FS-207
Time frame: up to 60 days
Minimum Serum Concentration (Cmin) of FS-207
Time frame: Up to 60 days
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of FS-207
Time frame: Up to 60 days
Time to Achieve Cmax (Tmax) of FS-207
Time frame: Up to 60 days
Confirmed Objective Response Rate(ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to 5 years
Duration of Response (DOR) per RECIST v1.1
Time frame: Up to 5 years
Disease Control Rate (DCR) per RECIST v1.1
Time frame: Up to 5 years
Progression-free Survival (PFS) per RECIST v1.1
Time frame: Up to 5 years
Overall Survival (OS) per RECIST v1.1
Time frame: Up to 5 years
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