Stopped: High levels of BRD9 degradation did not result in sufficient efficacy in heavily pre-treated synovial sarcoma and SMARCB1-null solid tumor patients treated with CFT8634 as a single agent.
This is an open-label, non-randomized, first-in-human Phase 1/2 study designed to evaluate the safety and tolerability of CFT8634 in subjects with synovial sarcoma and SMARCB1-null tumors who: have received prior systemic therapy; have relapsed/refractory tumors; have unresectable or metastatic disease; and are not candidates for available therapies known to confer clinical benefit. The study will characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of CFT8634.
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Frequency and severity of AEs and serious adverse events (SAEs)
Timeframe: From screening until at least 30 days after completion of study treatment
Number of subjects with changes between baseline and post-baseline safety assessments based on safety laboratory results graded by CTCAE v5.0
Timeframe: From screening until at least 30 days after completion of study treatment
Frequency of dose interruptions and dose reductions
Timeframe: From first dose until end of treatment
Incidence of dose limiting toxicities (DLTs)
Timeframe: From first dose until 28 days after first dose
Overall Response Rate (ORR)
Timeframe: Up to approximately 24 months