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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHangzhou SynRx Therapeutics Biomedical Technology Co., Ltd

About this trial

This interventional study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SYN818 as monotherapy in adult patients with advanced solid tumors

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • SYN818

Treatment groups

30 Participants
are divided into 1 treatment group