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Recruiting NCT07156253

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

Phase I Interventional Metastatic Solid Tumor Ovarian Cancer Breast Cancer BRCA 1 /2 and / or HRD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SYN818 and Olaparib will be administered.
Who it may be relevant to
Registry conditions: Metastatic Solid Tumor, Ovarian Cancer, Breast Cancer, BRCA 1 /2 and / or HRD. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug SYN818 and Olaparib will be administered
    Patients will orally receive SYN818 and Olaparib

Primary outcome measures

  • Maximum tolerated dose (MTD) [Time frame: Up to 3 years]
  • Number of participants with Dose Limiting Toxicities (DLTs) [Time frame: From first dose of study treatment until the end of Cycle 1 (each cycle is 21-days)]
  • Number of participants experiencing adverse events (AEs)/serious adverse events (SAEs) [Time frame: From time of information consent to 30 days post last dose, up to 3 years]
Secondary outcome measures (7)
  • Pharmacokinetic (PK) parameters [Time frame: Up to 3 years]
  • Pharmacokinetic (PK) parameters [Time frame: Up to 3 years]
  • Pharmacokinetic (PK) parameters [Time frame: Up to 3 years]
  • Pharmacokinetic (PK) parameters [Time frame: Up to 3 years]
  • Objective Response Rate (ORR) [Time frame: Up to 3 years]
  • Duration of Response (DoR) and Time to Response (TTR) [Time frame: Up to 3 years]
  • Progression Free Survival (PFS) [Time frame: Up to 3 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • FuDan University Shanghai Cancer Center — Shanghai
  • FuDan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT07156253 · SYN-818-102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗