Maintenance Combinatorial Myeloid Immunotherapy for Unresectable Pancreatic Cancer

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT07199764
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Odetiglucan — DRUG
    Odetiglucan 4 mg/kg IV every 3 weeks
  • Mitazalimab — DRUG
    Mitazalimab 0.9 mg/kg IV every 3 weeks

Study Details

Phase II, open-label, single-arm study of CD40/Dectin-1 immunotherapy as maintenance treatment in patients with unresectable pancreatic ductal adenocarcinoma (PDA) who have not progressed following 4-8 months of first line (1L) chemotherapy.

Key Dates

Start date
Nov 25, 2025
Status verified
Jun 2026
Primary completion
Oct 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    Patients with metastatic pancreatic adenocarcinoma achieving a partial response (PR) on 1L chemotherapy
  • Experimental: Cohort B
    Patients with metastatic adenocarcinoma achieving stable disease (SD) on 1L chemotherapy
  • Experimental: Cohort C
    Patients with locally advanced pancreatic adenocarcinoma who have achieved disease stability partial response (PR) or stable disease (SD) on 1L chemotherapy
  • No Intervention: Prospective Cohort A
    Observational Prospective patient with metastatic pancreatic adenocarcinoma achieving a partial response (PR) on 1L chemotherapy
  • No Intervention: Prospective Cohort B
    Observational Prospective Patients with metastatic adenocarcinoma achieving stable disease (SD) on 1L chemotherapy
  • No Intervention: Prospective Cohort C
    Observational Prospective Patients with locally advanced pancreatic adenocarcinoma who have achieved disease stability partial response (PR) or stable disease (SD) on 1L chemotherapy
  • No Intervention: Retrospective Cohort A
    Observational Retrospective patient with metastatic pancreatic adenocarcinoma achieving a partial response (PR) on 1L chemotherapy
  • No Intervention: Retrospective Cohort B
    Observational Retrospective Patients with metastatic adenocarcinoma achieving stable disease (SD) on 1L chemotherapy
  • No Intervention: Retrospective Cohort C
    Observational Retrospective Patients with locally advanced pancreatic adenocarcinoma who have achieved disease stability partial response (PR) or stable disease (SD) on 1L chemotherapy

Primary Outcome Measure

Median progression-free survival (mPFS) of 7.5 months in Cohort A [ Time Frame: 7.5 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in Philadelphia, PA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Hospital of the University of Pennsylvania· Philadelphia, PA

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