Study of SYN608 for the Treatment of Advanced or Metastatic Solid Tumors

NCT07088588 | Not Yet Recruiting Phase 1

• 1 other identifier: SYN-608-101
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

Brief Summary

This interventional study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SYN608 as monotherapy in adult patients with advanced solid tumors

Conditions

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

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)

SYN608 tablet

EXPERIMENTAL

SYN608 tablet monotherapy

Drug: SYN608

Interventions

SYN608 DRUG

Patients will orally receive SYN608

SYN608 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 or other advanced solid tumors who have experienced disease progression, and available standard of care (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 Homologous Recombination (HR) pathway (by the detection method of next generation sequencing \[NGS\])
• 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 Poly (ADP) ribose glycohydrolase (PARG) inhibitors;
• Serious allergy to the study drug or any of its excipients;
• 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;
• History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease;
• 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

Location

Shanghai GoBroad Cancer Hospital China Pharmaceutical University

Shanghai, Shanghai Municipality, 200131, China

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Ovarian Neoplasms; Breast 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

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: July 18, 2025
• First Posted: July 28, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)