RecruitingPhase 1NCT06666270

Study of SYN818 for the Treatment of Advanced or Metastatic Solid Tumors

A First-in-human, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Anti-tumor Activity of SYN818, a DNA Polymerase Theta (POLQ) Inhibitor Alone in Patients With Locally Advanced or Metastatic Solid Tumors


Sponsor

Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd

Enrollment

30 participants

Start Date

Nov 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This interventional study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SYN818 as monotherapy in adult patients with advanced solid tumors


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental drug called SYN818 — which targets a DNA repair protein called Pol theta (POLQ) — in people with advanced or metastatic solid tumors (breast, ovarian, prostate, or other cancers) who have a defect in the body's DNA repair system, including BRCA mutations, and whose cancer has progressed after standard treatments. **You may be eligible if...** - You are 18 or older - You have been diagnosed with advanced or metastatic breast cancer, ovarian cancer, prostate cancer, or another solid tumor - Your cancer has progressed and all available standard treatments have been exhausted - You are willing to provide a tumor tissue or blood sample for genetic testing - You have at least one measurable tumor on scans - Your general health, organ function, and blood counts are adequate **You may NOT be eligible if...** - You have previously taken a POLQ inhibitor drug (the same class as SYN818) - You are allergic to the drug's active ingredient or components - You have active brain or spinal fluid metastases that are not well-controlled - You have another cancer diagnosed within the past 5 years (certain low-risk cancers may be exceptions) - You have conditions affecting swallowing or gut absorption of the drug - You have signs of or risk factors for bone marrow failure (MDS/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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSYN818

Patients will orally receive SYN818


Locations(2)

Henan Cancer Hospital

Zhengzhou, Henan, China

Fudan University Shanghai Cancer Center.

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06666270


Related Trials