SYN818 plus olaparib for advanced or metastatic BRCA‑mutant or HRD solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase Ib, open‑label, multicenter trial gives SYN818 together with oral olaparib to adults with locally advanced or metastatic solid tumors that harbor BRCA mutations or homologous recombination repair (HRR) defects. It enrolls patients in defined cohorts and collects safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti‑tumor activity data, with responses assessed by RECIST v1.1. Eligible participants include adults with measurable disease and ECOG 0–1 who have adequate organ and bone marrow function; some cohorts focus specifically on epithelial ovarian cancer or HER2‑negative breast cancer. Primary objectives are early safety and tolerability while secondary objectives include PK/PD profiling and initial signals of clinical benefit.

Why it matters

Who can join: the full rules

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.

Where it's running

• FuDan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting
• FuDan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Duo Wu
• Email: wuduo@synrx.cn
• Phone: +86-571-86360796

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.