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

NCT06666270 | Recruiting Phase 1

• 1 other identifier: SYN-818-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Number of participants with Dose Limiting Toxicities (DLTs)

  Severity of adverse events as assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

  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)

  Number of participants with incidence of adverse events and with serious adverse events including changes from baseline in laboratory parameters, vital signs, ECGs, and physical examination, etc.

  From time of information consent to 30 days post last dose, up to 3 years

• Maximum tolerated dose (MTD)

  MTD is defined as the maximum dose level at which ≤1 patient have DLTs during the DLT observation period, and it should be determined with 6 evaluable patients.

  Up to 3 years

Secondary Outcomes (5)

• Pharmacokinetic (PK) parameters and Pharmacodynamic (PD) marker change

  Up to 3 years

• Objective Response Rate (ORR)

  Up to 3 years

• Duration of Response (DoR) and Time to Response (TTR)

  Up to 3 years

• Progression Free Survival (PFS)

  Up to 3 years

• Serum tumor marker change: CA125, etc. (OC), prostatic specific antigen (PSA, prostate cancer) decreased, and specific tumor markers for other tumor types may also be included (to be assessed by clinical investigators)

  Up to 3 years

Study Arms (1)

SYN818 tablet

EXPERIMENTAL

SYN818 tablet monotherapy

Drug: SYN818

Interventions

SYN818 DRUG

Patients will orally receive SYN818

SYN818 tablet

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd: lead

Study Sites (2)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

Fudan University Shanghai Cancer Center.

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Ovarian Neoplasms; Breast Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Tongfu Xu, PHD

CONTACT

+86-571-86360796; xutongfu@synrx.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 30, 2024
• Study Start: November 21, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)