A Clinical Trial to Evaluate the Safety, Tolerability and Clinical Efficacy of M3T01 Monotherapy and in Combination With Pembrolizumab and Other Systemic Therapies

This is a first-in-human, phase I, open-label, dose escalation, dose expansion clinical trial designed to evaluate the safety, tolerability and preliminary clinical efficacy of M3T01 monotherapy and in combination with standard of care systemic therapies (including pembrolizumab, temozolomide, and FOLFOX) in subjects with advanced solid tumors. Within the Part 1 dose escalation stage of the study, the maximum tolerated dose (MTD) or maximum administered dose (MAD) for M3T01 monotherapy and in combination with pembrolizumab will be determined. The recommended phase 2 dose (RP2D) will be determined based upon available pharmacokinetic, pharmacodynamic, and preliminary clinical efficacy data and will be equal to or lower than the MTD. M3T01 will be administered at the RP2D in combination with standard of care systemic therapies (including pembrolizumab, temozolomide, and FOLFOX) in the Part 2 dose expansion stage of the clinical trial. Up to 48 subjects will be enrolled in the Part 1 dose escalation stage of the study (depending on observed toxicity and when the MTD/MAD is reached). The Part 2 dose expansion portion of the study will enroll up to 62 subjects.