Study of SYN818 for the Treatment of Advanced or Metastatic Solid Tumors (NCT06666270) | Clinical Trial Compass
RecruitingPhase 1
Study of SYN818 for the Treatment of Advanced or Metastatic Solid Tumors
China30 participantsStarted 2024-11-21
Plain-language summary
This interventional study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SYN818 as monotherapy in adult patients with advanced solid tumors
Who can participate
Age range18 Years
SexALL
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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 …
What they're measuring
1
Number of participants with Dose Limiting Toxicities (DLTs)
Timeframe: From first dose of study treatment until the end of Cycle 1 (each cycle is 21-days)
2
Number of participants experiencing adverse events (AEs)/serious adverse events (SAEs)
Timeframe: From time of information consent to 30 days post last dose, up to 3 years