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

NCT07565155 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 20251062
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Pancreatic Adenocarcinoma; Homologous Recombination Deficiency

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Objective Response Rate (ORR) is defined as the proportion or percentage of patients with confirmed partial (PR) or complete (CR) best overall response.

  Baseline, Up to 60 months

Secondary Outcomes (2)

• Progression-Free Survival (PFS)

  Up to 60 months

• Overall Survival (OS)

  Up to 60 months

Study Arms (1)

Lorigerlimab Group

EXPERIMENTAL

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.

Drug: Lorigerlimab

Interventions

Lorigerlimab DRUG

6mg/kg every 3 weeks (Q3W) Intravenous

Also known as: MGD019

Lorigerlimab Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Life expectancy of at least 3 months.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ function defined as the following laboratory values within 14 days of Cycle 1 Day 1:
• Neutrophils \>1000/μL (stable off any growth factor within 4 weeks of first study treatment administration).
• Platelets \> 100 × 103/μL (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration).
• Hemoglobin \> 8.0 g/dL (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration).
• Serum creatinine \< 1.5 × upper limit of normal (ULN), or creatinine clearance ≥30 mL/min (measured or calculated using Modification of Diet in Renal Disease (MDRD) or Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi)).

You may not qualify if:

• 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.
• Has clinically significant ascites defined as requiring 1 or more therapeutic paracenteses in the last 4 weeks prior to study entry.
• Grade 2 or higher peripheral neuropathy
• Clinically significant gastrointestinal disorders including:
• 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.
• Bowel obstruction or impending bowel obstruction within the past 3 months.
• Clinically significant (i.e. active) cardiovascular disease:
• Cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication.
• Pericarditis or clinically significant pericardial effusion.
• Any history of myocarditis.
• Known central nervous system (CNS) involvement as follows: a. Untreated CNS metastases. b. Leptomeningeal metastases. c. NOTE: Patients may be eligible if CNS metastases have been treated and patients have neurologically returned to baseline (except for residual signs and symptoms related to the CNS treatment).
• Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 1 year prior to the first dose of study treatment (i.e. patients with a history of prior malignancy are eligible if treatment was completed at least 1 year before the first dose of study treatment and the patient has no evidence of disease). Patients with history of prior early-stage basal/squamous cell skin cancer or noninvasive or in situ cancers who have undergone definitive treatment at any time are also eligible.

Sponsors & Collaborators

• Peter Hosein, MD: lead
• MacroGenics: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Study Officials

• Peter J Hosein, MBBS

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter J Hosein, MBBS

CONTACT

(305) 243-6606; phosein@miami.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Clinical

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2031
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)