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Not yet recruiting NCT07088588

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

Phase I Interventional Advanced Solid Cancer Metastatic Solid Tumor Ovarian Cancer Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SYN608.
Who it may be relevant to
Registry conditions: Advanced Solid Cancer, Metastatic Solid Tumor, Ovarian Cancer, Breast Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A First-in-Human Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SYN608, a Poly ADP-ribose Glycohydrolase (PARG) Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors

Overview

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

Detailed description

This study is a Phase I, open-label, multicentre study of SYN608 administered orally in patients with advanced solid tumors

Interventions

  • Drug SYN608
    Patients will orally receive SYN608

Primary outcome measures

  • Maximum tolerated dose (MTD) [Time frame: Up to 3 years]
  • Number of participants with Dose Limiting Toxicities (DLTs) [Time frame: 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) [Time frame: From time of information consent to 30 days post last dose, up to 3 years]
Secondary outcome measures (7)
  • Pharmacokinetic (PK) parameters [Time frame: Up to 3 years]
  • Pharmacokinetic (PK) parameters [Time frame: Up to 3 years]
  • Pharmacokinetic (PK) parameters [Time frame: Up to 3 years]
  • Pharmacokinetic (PK) parameters [Time frame: Up to 3 years]
  • Objective Response Rate (ORR) [Time frame: Up to 3 years]
  • Duration of Response (DoR) and Time to Response (TTR) [Time frame: Up to 3 years]
  • Progression Free Survival (PFS) [Time frame: Up to 3 years]

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 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • FuDan University Shanghai Cancer Center — Shanghai
  • Shanghai GoBroad Cancer Hospital China Pharmaceutical University — Shanghai

Identifiers

NCT: NCT07088588 · SYN-608-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗