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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-26

Study Completion Date

2029-02-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC

NCT07002177

Metastatic Breast Cancer Breast Cancer Stage I Breast Cancer Stage II +2 more

RECRUITING PHASE1/PHASE2

Phase I Study of SYD985 With Niraparib in Patients With Solid Tumors

NCT04235101

Solid Tumor

COMPLETED PHASE1

Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer

NCT06413745

HER2 Expression / Amplification in Patients With Biliary Tract Cancer

RECRUITING PHASE2

A Study to Test How Well Different Doses of BI 3820768 Are Tolerated by People With Advanced Cancer (Solid Tumours)

NCT07306559

Advanced Relapsed or Refractory Germ Cell Tumours Advanced Relapsed or Refractory Endometrial Cancer Advanced Relapsed or Refractory Ovarian Cancer

NOT_YET_RECRUITING PHASE1

Open Label Study to Assess Efficacy and Safety of Olaparib in Confirmed Genetic BRCA1 or BRCA2 Mutation Pats

NCT01078662

Ovarian Breast Prostate +2 more

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic Solid Tumor Ovarian Cancer Breast Cancer BRCA 1 /2 and / or HRD Advanced Solid Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SYN818 combination with Olaparib

Group Type EXPERIMENTAL

SYN818 and Olaparib will be administered

Intervention Type DRUG

Patients will orally receive SYN818 and Olaparib

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SYN818 and Olaparib will be administered

Patients will orally receive SYN818 and Olaparib

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No