Lorigerlimab (MGD019) in Patients With Pancreatic Adenocarcinoma and Homologous Recombination Deficiency

Part of paid clinical trials in Miami, Florida.

Sponsor
Peter Hosein, MD
Study ID
NCT07565155
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Lorigerlimab — DRUG
    6mg/kg every 3 weeks (Q3W) Intravenous

Study Details

The purpose of this study is to determine the objective response rate (ORR) to lorigerlimab in patients with refractory pancreatic ductal adenocarcinoma (PDAC) and pathogenic germline variants (PGVs) in breast cancer type 1 or 2 susceptibility protein (BRCA1/2), Partner and Localizer of BRCA2 (PALB2) and radiation sensitive protein 51 C or D (RAD51C/D).

Key Dates

Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Jun 1, 2031
Completion
Jun 1, 2031

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lorigerlimab Group
    Participants will receive Lorigerlimab with docetaxel (experimental arm) or docetaxel alone (standard-of-care arm). Participants who were randomized to the standard-of-care arm (docetaxel) and meet the criteria for radiographic disease progression may be eligible to receive Lorigerlimab as a monotherapy. Total participation duration is up to 3 years.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Baseline, Up to 60 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Peter J Hosein, MBBS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
University of Miami· Miami, FL

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