Study of SYN608 for the Treatment of Advanced or Metastatic Solid Tumors (NCT07088588) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Study of SYN608 for the Treatment of Advanced or Metastatic Solid Tumors
China105 participantsStarted 2025-07-31
Plain-language 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
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 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 …
What they're measuring
1
Maximum tolerated dose (MTD)
Timeframe: Up to 3 years
2
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)
3
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