NCT07156253 Study of SYN818 With Olaparib for the Treatment of Locally Advanced or Metastatic Solid Tumors
| NCT ID | NCT07156253 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd |
| Condition | Metastatic Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2025-08-26 |
| Primary Completion | 2028-08-25 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 110 participants in total. It began in 2025-08-26 with a primary completion date of 2028-08-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07156253 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07156253 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07156253 currently recruiting?
Yes, NCT07156253 is actively recruiting participants. Contact the research team at wuduo@synrx.cn for enrollment information.
Where is the NCT07156253 trial being conducted?
This trial is being conducted at Shanghai, China, Shanghai, China.
Who is sponsoring the NCT07156253 clinical trial?
NCT07156253 is sponsored by Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd. The trial plans to enroll 110 participants.