RecruitingPhase 1NCT07156253

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

A Phase Ib Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SYN818 With Olaparib in Patients With Locally Advanced or Metastatic Solid Tumors


Sponsor

Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd

Enrollment

110 participants

Start Date

Aug 26, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This interventional study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SYN818 with Olaparib in adult patients with locally advanced or metastatic solid tumors


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a combination of two drugs — SYN818 and olaparib — for people with advanced or metastatic solid tumors, particularly ovarian cancer or HER2-negative breast cancer, who carry BRCA gene mutations or similar DNA repair defects. Both drugs target cancer cells with broken DNA repair systems. **You may be eligible if...** - You are 18 or older with an advanced or metastatic solid tumor and have exhausted all standard treatment options - You have confirmed BRCA mutations or a similar DNA repair deficiency (called HRD) - For Part 2: you have locally advanced or metastatic ovarian cancer or HER2-negative breast cancer - You have at least one measurable tumor on imaging **You may NOT be eligible if...** - You have previously taken a DNA Polymerase Theta (POLQ) inhibitor drug - You have another active cancer (unless treated and in remission for 5+ years) - You have symptomatic or uncontrolled cancer spread to the brain - You have a history of MDS or AML Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSYN818 and Olaparib will be administered

Patients will orally receive SYN818 and Olaparib


Locations(2)

FuDan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

FuDan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT07156253


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