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drugset / Trial / NCT05484011

A Maintenance Therapy Study of Odetiglucan With CDX-1140 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

NCT05484011 ↗

Phase 1 Terminated 5 enrolled HiberCell, Inc. Celldex Therapeutics · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

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 32 weeks of chemotherapy. Up to 45 patients will be enrolled and dosed (30 patients in Part A and 15 in Part B).

Timeline

Start
2022-12-15
Primary completion
2024-03-04
Completion
2024-03-04

Drugs

EvaluationDrugModalityDoseRoute
Subject CDX-1140 Monoclonal antibody 0.72 mg/kg Intravenous
Subject CDX-1140 Monoclonal antibody 1.5 mg/kg Intravenous
Subject Odetiglucan Other / unclassified 4 mg/kg Intravenous

Indications

pancreatic adenocarcinoma