A Phase 2 Trial of Lorigerlimab (MGD019) in Patients With Pancreatic Adenocarcinoma and Homologous Recombination Deficiency

Peter Hosein, MD

Summary

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).

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 1. Voluntarily agree to participate by giving signed, dated, and written informed consent prior to any study-specific procedures. 2. ≥ 18 years of age. 3. Histologically confirmed pancreas carcinoma with metastatic disease. Neuroendocrine neoplasms are not eligible. Adenosquamous, squamous and acinar histologies are allowed provided criteria #5 is fulfilled, and these histologies comprise no more than 10% of the total accrual. 4. Measurable disease on baseline imaging by CT (or MRI where CT is contraindicated) based on RECIST 1.1. 5. Documented germline mutation in BRCA1,…

Interventions

Drug
Lorigerlimab
6mg/kg every 3 weeks (Q3W) Intravenous

Location

University of Miami
Miami, Florida

A Phase 2 Trial of Lorigerlimab (MGD019) in Patients With Pancreatic Adenocarcinoma and Homologous Recombination Deficiency

Summary

Eligibility

Interventions

Location

Compensation

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Details

Conditions