NCT07088588

Study of SYN608 for the Treatment of Advanced or Metastatic Solid Tumors

A First-in-Human Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SYN608, a Poly ADP-ribose Glycohydrolase (PARG) Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This interventional study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SYN608 as monotherapy in adult patients with advanced solid tumors

Detailed description

This study is a Phase I, open-label, multicentre study of SYN608 administered orally in patients with advanced solid tumors

Conditions

• Advanced Solid Cancer
• Metastatic Solid Tumor
• Ovarian Cancer
• Breast Cancer
• BRCA Mutation
• HRR Deficiency

Interventions

Type	Name	Description
DRUG	SYN608	Patients will orally receive SYN608

Timeline

• Start date: 2025-07-31
• Primary completion: 2028-07-31
• Completion: 2028-10-31
• First posted: 2025-07-28
• Last updated: 2025-07-28

Locations

2 sites across 1 country: China