Lorigerlimab (MGD019) in Patients With Pancreatic Adenocarcinoma and Homologous Recombination Def… (NCT07565155) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Lorigerlimab (MGD019) in Patients With Pancreatic Adenocarcinoma and Homologous Recombination Deficiency
United States40 participantsStarted 2026-06-01
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Voluntarily agree to participate by giving signed, dated, and written informed consent prior to any study-specific procedures.
✓. ≥ 18 years of age.
✓. 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.
✓. Measurable disease on baseline imaging by CT (or MRI where CT is contraindicated) based on RECIST 1.1.
✓. Documented germline mutation in BRCA1, BRCA2, PALB2, radiation sensitive protein 51 C (RAD51C), or radiation sensitive protein 51 D (RAD51D) that is known or predicted to be detrimental or lead to loss of function on a chemiluminescence immunoassay (CLIA)-approved assay (e.g. Invitae, Ambry, Myriad, Tempus).
✓. Must have an accessible tumor amenable to a safe biopsy where the major complication rate is ≤ 1.5% in the judgement of the investigator.
✓. Must have prior exposure and disease progression after at least one line of platinum-based chemotherapy. Platinum-based chemotherapy given in the neo-adjuvant or adjuvant setting also satisfies this requirement if progression occurs within 1 year of the end of adjuvant therapy.
✓. Prior receipt of a poly (ADP-ribose) polymerase (PARP) inhibitor is allowed but not mandatory.
Exclusion criteria
✕. Has received any prior therapy with an anti-PD-1/PD-L1 antibody or an anti-cytotoxic T lymphocyte-associated (CTLA) protein 4 (anti-CTLA-4) antibody.
✕. Any history of gastrointestinal perforation unless the affected area has been deemed by the investigator to no longer be a risk for perforation.
✕. History of clinically significant gastrointestinal bleeding within 4 weeks prior to initiation of study treatment.
✕. History of acute pancreatitis within 4 weeks prior to the initiation of study treatment.
✕. Diverticulitis that is clinically significant in the opinion of the investigator based on the extent or severity of known disease and/or the occurrence of clinically significant disease flares within 4 weeks prior to the initiation of study treatment administration.