This is a multiple institution, open-label, 2-part Phase 1b study to determine the MTD (and/ or RP2D), safety, tolerability, and preliminary efficacy of the combination of odetiglucan and CDX-1140 for the treatment of patients with metastatic PDAC with evidence of response or stable disease during a minimum of 16 and no more than 24 weeks of therapy immediately prior to study enrollment. Part A will identify the MTD and/ or RP2D and Part B will assess an alternative dosing regimen of RP2D.~In Part A, a 3 + 3 de-escalation design will be used to determine the MTD of CDX-1140 when administered in combination with odetiglucan (the starting dose for CDX-1140 is that anticipated to be the recommended phase 2 dose (RP2D) based on prior Phase 1 clinical assessment); up to 15 patients will be enrolled. The following 2 treatment cohorts will be evaluated for safety, tolerability, and preliminary efficacy: Dose Level 1: Odetiglucan 4 mg/kg IV plus CDX-1140 1.5 mg/kg~• Dose Level -1: Odetiglucan 4 mg/kg IV plus CDX-1140 0.72 mg/kg Treatment will be administered in 3-week cycles. Odetiglucan will be administered weekly on Days 1, 8, and 15 of each cycle followed ~15-30 minutes later by administration of CDX-1140 1.5 mg/kg or 0.72 mg/kg IV Day 1 of each cycle.~Part B will enroll 15 patients that will receive odetiglucan 4 mg/kg plus the CDX-1140 RP2D identified in Part A. As in Part A, treatment will be administered in 3-week cycles, however, both odetiglucan and CDX-1140 will be administered on Day 1 of each cycle. All patients enrolled into the study will receive pre- and post-infusion medications.
The primary objective of this maintenance therapy study is to identify the maximum tolerated dose (MTD) and/ or recommended Phase 2 dose (RP2D), and evaluate the safety, tolerability, and dose-limiting toxicities (DLTs) of odetiglucan in combination with CDX-1140 in patients with metastatic PDAC with evidence of response or stable disease following a minimum of 16 and no more than 24 weeks of chemotherapy.~Up to 30 patients will be enrolled and dosed (15 patients in Part A and B, respectively).