Study of SYN818 With Olaparib for the Treatment of Locally Advanced or Metastatic Solid Tumors

Launched by HANGZHOU SYNRX THERAPEUTICS BIOMEDICAL TECHNOLOGY CO., LTD ·

Keywords

ClinConnect Summary

This is a Phase 1b, open-label study testing a combination pill of SYN818 with Olaparib in adults with locally advanced or metastatic solid tumors that have BRCA mutations or problems with the DNA repair system (HRD). The goal is to learn about safety and tolerability, how the drugs behave in the body (pharmacokinetics), and to spot early signs of anti-tumor activity. Eligible participants are adults 18 and older with a confirmed BRCA mutation or HRD, including ovarian cancer or HER2-negative breast cancer, and at least one measurable tumor. They should have good overall health (ECOG 0–1), adequate organ function, and have already exhausted standard treatments. The study is being conducted in Shanghai, China at Fudan University Shanghai Cancer Center and is sponsored by Hangzhou SynRx Therapeutics.

Participants will take SYN818 together with Olaparib by mouth. The study’s main aim is to identify the highest dose that can be given safely (dose-finding) and to monitor for side effects. In addition, researchers will collect blood data to understand how the drugs are processed in the body and will track any tumor responses, duration of response, and progression-free survival as early indicators of benefit. This is not a randomized trial, so there is no comparison group. About 110 participants are planned, and the study is currently recruiting with anticipated completion in 2029. Results are not yet available.

Gender

ALL

Eligibility criteria