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Study of SYN818 With Olaparib for the Treatment of Locally Advanced or Metastatic Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT07156253•Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd

View on ClinicalTrials.gov

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

Detailed Description

This study is a Phase Ib, open-label, multicentre study of SYN818 with Olaparib administered orally in patients with locally advanced or metastatic solid tumors harboring mutations in BRCA and/or defects in the homologous recombination repair (HRR) pathway

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Having signed the written Informed Consent Form (ICF);
•Male or female aged ≥18 years;
•Life expectancy ≥12 weeks;
•Eastern Cooperative Oncology Group (ECOG) Performance Score 0 or 1;
•Participant has a histologically confirmed diagnosis of advanced or metastatic solid tumor and has exhausted all standard-of-care treatment options, with documented BRCA mutations and/or homologous recombination repair deficiency (Part 1).
•Participant has histologically or cytologically confirmed locally advanced or metastatic epithelial ovarian cancer or HER2-negative breast cancer, with documented BRCA mutations and/or homologous recombination repair deficiency (Part 2).
•At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
•No serious hematological, cardiopulmonary, or liver or kidney diseases other than the primary disease;
•Adequate organ function and bone marrow function.

Exclusion Criteria

•Previous or current use of DNA Polymerase Theta (POLQ) inhibitors;
•Current or previous other malignancy unless treated radically and with no evidence of recurrence or metastasis within the past 5 years;
•Central nervous system (CNS) metastasis or meningeal metastasis with clinical symptoms, or other evidence indicating that CNS metastasis or meningeal metastasis has not been adequately controlled;
•Patients with Myelodysplastic syndrome (MDS)/Acute myeloid leukemia (AML) or with features suggestive of MDS/AML;
•Dysphagia or refractory nausea and vomiting, malabsorption, extracorporeal biliary shunts, or gastrointestinal disorders that affect drug absorption, e.g., Crohn's disease, ulcerative colitis, or short bowel syndrome, or other malabsorption conditions;
•Treatment with an anti-cancer small molecule within 5 half-lives (t1/2), or 2 weeks, whichever is shorter;
•History of use within 2 weeks prior to the first dose of the study treatment and need to use protocol-prohibited potent inhibitors or potent inducers of cytochrome P450 (CYP) 3A4/BCRP/P-gp during the study;
•Serious systemic diseases or laboratory abnormalities or other conditions that, at the Investigator's discretion, will make it unsuitable for the patient to participate in this clinical trial.

Locations (2)

FuDan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

FuDan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

August 26, 2025

Primary Completion Date

August 25, 2028

Completion Date

February 25, 2029

Last Updated

September 5, 2025

Enrollment

110

ESTIMATED participants

Conditions

Metastatic Solid TumorOvarian CancerBreast CancerBRCA 1 /2 and / or HRDAdvanced Solid Tumors

Interventions

SYN818 and Olaparib will be administered

DRUG

Contacts

Duo Wu

CONTACT

+86-571-86360796 wuduo@synrx.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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