Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
204

Summary

Conditions
  • Carcinoma
  • Metastatic Pancreatic Adenocarcinoma
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 101 years
Gender
Both males and females

Description

This is a Phase 1b/2, multicenter, open-label, dose-escalation, and dose-expansion study to assess the safety, preliminary antitumor activity, immunogenicity, and PK of oleclumab with or without durvalumab in combination with chemotherapy administered in subjects with metastatic PDAC. Subjects with ...

This is a Phase 1b/2, multicenter, open-label, dose-escalation, and dose-expansion study to assess the safety, preliminary antitumor activity, immunogenicity, and PK of oleclumab with or without durvalumab in combination with chemotherapy administered in subjects with metastatic PDAC. Subjects with previously untreated metastatic PDAC (1L metastatic PDAC) with be enrolled in Cohort A. Subjects with metastatic PDAC previously treated with gemcitabine-based chemotherapy (without exposure to 5-FU, capecitabine, or oxaliplatin, 2L metastatic PDAC) will be enrolled in Cohort B. The study consists of 2 parts, dose escalation (part 1) and dose expansion (Part 2).

Tracking Information

NCT #
NCT03611556
Collaborators
Not Provided
Investigators
Not Provided