The current design provides a window to analyze the impact of the ACT001+Pembrolizumab
combination on the tumor microenvironment and disease outcomes.
Phase 1b: The identified RP2D of combined ACT001 with Pembrolizumab will be determined by
standard 3+3 dose escalation methodology among three ACT001 dosages (200mg, 400mg and 800mg,
BID) with standard Pembrolizumab dosage. Patients will be dosed approximately 2 weeks prior
to surgical resection with a single dose of Pembrolizumab and ACT001. Tumor resection will be
performed and a biopsy will be obtained from the resected tumor tissue to evaluate the impact
of the study drugs on the TME. After recovery from surgery, patients will resume ACT001 and
Pembrolizumab until tumor progression (assessed by iRANO) or an AE requiring discontinuation
of study drug. The Safety Monitoring Committee (SMC) will review the data available from all
evaluable patients at each dose level prior to recommending escalation to the next dose
Phase 2a: Using the same dosing schedule and ACT001 dosage as determined in Phase 1b.
Patients will be randomized to receive either Pembrolizumab only treatment (Arm A, 10
patients) or ACT001 plus Pembrolizumab treatment (Arm B, 20 patients).
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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