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

NCT07156253 | Recruiting Phase 1

• 1 other identifier: SYN-818-102
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

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

Conditions

Metastatic Solid Tumor; Ovarian Cancer; Breast Cancer; BRCA 1 /2 and / or HRD; Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Maximum tolerated dose (MTD)

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

  Up to 3 years

• 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, Electrocardiogram (ECG), and physical examination, etc.

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

Secondary Outcomes (7)

• Pharmacokinetic (PK) parameters

  Up to 3 years

• Pharmacokinetic (PK) parameters

  Up to 3 years

• Pharmacokinetic (PK) parameters

  Up to 3 years

• Pharmacokinetic (PK) parameters

  Up to 3 years

• Objective Response Rate (ORR)

  Up to 3 years

Study Arms (1)

SYN818 combination with Olaparib

EXPERIMENTAL

Drug: SYN818 and Olaparib will be administered

Interventions

SYN818 and Olaparib will be administered DRUG

Patients will orally receive SYN818 and Olaparib

SYN818 combination with Olaparib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

FuDan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

FuDan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Ovarian Neoplasms; Breast Neoplasms; Kenny-Caffey syndrome, Type 1

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

Central Study Contacts

Duo Wu

CONTACT

+86-571-86360796; wuduo@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: August 27, 2025
• First Posted: September 5, 2025
• Study Start: August 26, 2025
• Primary Completion (Estimated): August 25, 2028
• Study Completion (Estimated): February 25, 2029
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)