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

Launched by HANGZHOU SYNRX THERAPEUTICS BIOMEDICAL TECHNOLOGY CO., LTD · Oct 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called SYN818 for adults with advanced solid tumors, including types of cancer like breast, ovarian, and prostate cancers. The main goals of the study are to see how safe SYN818 is, how well it is tolerated by patients, and if it can help treat these cancers when other treatments have not worked. This trial is currently not recruiting participants, but it will be open to adults aged 18 and older who have certain types of cancer and meet specific health criteria.

To be eligible for this trial, participants must have cancers that have progressed after standard treatments and must be willing to provide tumor samples for testing. They also need to have a reasonable life expectancy and good overall health, without serious medical conditions that could interfere with the study. Participants in the trial will receive SYN818 and will be monitored for any side effects and how their cancer responds to the treatment. It’s important to note that this trial has specific requirements, so not everyone with cancer will qualify. If you or a loved one are interested in participating, discussing this option with a healthcare provider can help determine suitability.

Gender

ALL

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, 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.
• Exclusion Criteria:
• • 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.