Stopped: Sponsor decision following completion of Phase I part not driven by safety reason
This is a Phase I/IIa, multicenter, open-label, consecutive cohorts, dose-escalation study of BT-001 with repeated IT administrations alone and in combination with IV infusions of pembrolizumab.
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Phase I: Safety and tolerability (Adverse Event reported per NCI-CTCAE v5.0)
Timeframe: Up to 5 years
Phase I, Part A: Recommended dose for Part B (RDPB) definition
Timeframe: Week 10-12
Phase IIa (except Soft Tissue Sarcoma cohort): Immune Overall Response Rate (iORR) by iRECIST
Timeframe: Up to 2 years
Phase IIa (Soft Tissue Sarcoma cohort): Immune Disease Control Rate (iDCR) at 6 months by iRECIST
Timeframe: Up to 6 months