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

Trial Title: Study of SYN818 for the Treatment of Advanced or Metastatic Solid Tumors

NCT ID: NCT06666270

Condition: Advanced Solid Cancer
Metastatic Solid Tumor
Ovarian Cancer
Breast Cancer
Prostate Cancer
BRCA Mutation
HRR Deficiency

Study type: Interventional

Study phase: Phase 1

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: SYN818
Description: Patients will orally receive SYN818
Arm group label: SYN818 tablet

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

Detailed description: This study is a Phase I, open-label, multicentre study of SYN818 administered orally in patients with advanced solid tumors

Criteria for 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; - 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.

Gender: All

Gender based: Yes

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: SynRx Therapeutics

Address:
City: Shanghai
Country: China

Contact:
Last name: Tongfu Xu, PhD

Phone: +86-571-86360796
Email: xutongfu@synrx.cn

Start date: November 30, 2024

Completion date: December 30, 2026

Lead sponsor:
Agency: Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd
Agency class: Industry

Source: Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06666270