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

NCT05484011 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-04-10

No results posted yet for this study

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).

Conditions

  • Metastatic Pancreatic Adenocarcinoma

Interventions

BIOLOGICAL

odetiglucan

Odetiglucan is a soluble, β-1,3/1,6 glucan isolated from the cell wall of a proprietary Saccharomyces cerevisiae yeast strain. Odetiglucan acts as a Pathogen-Associated Molecular Pattern (PAMP).

BIOLOGICAL

CDX-1140

A fully human agonist anti-CD40 monoclonal antibody

Sponsors & Collaborators

  • Celldex Therapeutics

    collaborator INDUSTRY

  • HiberCell, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark O'Hara · University of Pennsylvania

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-15
Primary Completion
2024-03-04
Completion
2024-03-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05484011 on ClinicalTrials.gov