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

Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd

Status and phase

Enrolling

Phase 1

Conditions

Breast Cancer

BRCA 1 /2 and / or HRD

Advanced Solid Tumors

Ovarian Cancer

Metastatic Solid Tumor

Treatments

Drug: SYN818 and Olaparib will be administered

Study type

Interventional

Funder types

Industry

Identifiers

NCT07156253

SYN-818-102

Details and patient eligibility

About

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

Full 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

Enrollment

110 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.