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Clinical Trials in China / NCT06666270
Recruiting Phase 1

Study of SYN818 for the Treatment of Advanced or Metastatic Solid Tumors

NCT06666270 · tracked via the Priya Life Science China tracker
Sponsor
Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd
Phase
Phase 1
Started
2024-11-21
Last updated
2025-07-20

Condition(s) studied

Advanced Solid CancerMetastatic Solid TumorOvarian CancerBreast CancerProstate CancerBRCA MutationHRR Deficiency

Investigational drug(s) / intervention(s)

SYN818

SYN818: Patients will orally receive SYN818

Study summary

This interventional study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SYN818 as monotherapy in adult patients with advanced solid tumors

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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; * Patients with histologically or cytologically confirmed locally advanced or metastatic breast cancer, ovarian cancer, prostate cancer or other advanced solid tumors who have experienced disease progression, and available SOC therapies had been exhausted; * be willing to provide tumor tissue samples (fresh frozen \[SF\] or previously retained paraffin-embedded \[FFPE\] tumor tissue samples) or peripheral blood germline DNA or ctDNA sample to detect BRCA mutation, or other deficiency in the HR pathway (by the detection method of next generation sequencing \[NGS\]) * At least one measurable lesion according to 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 POLQ inhibitors; * Hypersensitivity to the active pharmaceutical ingredient or any excipient of SYN818; * 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; * Other malignant tumors than the study tumors within 5 years prior to the first dose of the study drug, except for localized cancers that have been evidently cured or disease-free for at least 3 years, such as basal or squamous cell skin cancer, superficial bladder cancer, prostate carcinoma in situ, carcinoma in situ of cervix, or carcinoma in situ of breast; * 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; * Major surgery or serious trauma within 4 weeks prior to the first dose of the study treatment or major surgery planned during the trial period, and none of the AEs related to surgery or major trauma have resolved (to ≤ CTCAE v5.0 Grade 1 or baseline level) before the first dose of the study drug; * 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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Henan Cancer Hospital Zhengzhou Henan Recruiting
Fudan University Shanghai Cancer Center. Shanghai Shanghai Municipality Recruiting

More Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06666270 on ClinicalTrials.gov ↗ ← All trials in China