Lorigerlimab for Pancreatic Cancer

PJ
Overseen ByPeter J Hosein, MBBS
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Peter Hosein, MD
Must be taking: Platinum-based chemotherapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, lorigerlimab, for individuals with pancreatic cancer unresponsive to other treatments. The researchers aim to evaluate lorigerlimab's effectiveness alone or with another drug, docetaxel, in shrinking tumors. Participants should have metastatic pancreatic cancer, a specific gene mutation (such as BRCA1/2), and prior experience with platinum-based chemotherapy. If the cancer progresses on standard treatment, participants may switch to lorigerlimab alone. This study offers hope for those with difficult-to-treat pancreatic cancer seeking new options. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing access to potentially effective new therapies.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, there is a requirement to recover from any significant side effects of recent treatments before starting the trial.

Is there any evidence suggesting that lorigerlimab is likely to be safe for humans?

Studies have shown that lorigerlimab is generally safe for humans. In one study involving 43 patients with advanced solid tumors, lorigerlimab was well-tolerated, with most participants not experiencing serious side effects. However, another study reported a serious side effect in one patient: neutropenia, a drop in white blood cells, which led to septic shock and was fatal. Despite this, other studies did not directly link fatal side effects to lorigerlimab. In a larger study with 127 patients, the treatment was considered safe for most, as it did not cause severe problems.

Overall, while some serious events have occurred, the treatment has been manageable for most participants in trials so far.12345

Why do researchers think this study treatment might be promising for pancreatic cancer?

Lorigerlimab is unique because it is an experimental treatment that combines with docetaxel to target pancreatic cancer in a new way. Unlike traditional treatments that primarily rely on chemotherapy alone, Lorigerlimab offers a potential new mechanism by acting as a monoclonal antibody designed to enhance the body's immune response against cancer cells. Researchers are excited because this approach might lead to more effective targeting of cancer cells and better outcomes for patients, especially those who do not respond well to standard chemotherapy options like gemcitabine or FOLFIRINOX. The possibility of using Lorigerlimab as a monotherapy for those showing disease progression adds an extra layer of hope for improved patient care.

What evidence suggests that lorigerlimab might be an effective treatment for pancreatic cancer?

Research has shown that lorigerlimab might help treat pancreatic cancer, especially in patients with certain genetic changes. In earlier studies, lorigerlimab showed promise in slowing tumor growth and delaying disease progression. In this trial, participants will receive either lorigerlimab with docetaxel or docetaxel alone. One study found that combining lorigerlimab with another treatment improved survival rates at six and nine months compared to standard treatments. Although the data is still developing, these early results suggest lorigerlimab could help manage pancreatic cancer in some cases.25678

Who Is on the Research Team?

PJ

Peter J Hosein, MBBS

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults (18+) with metastatic pancreatic cancer who have a specific inherited gene mutation (BRCA1/2, PALB2, RAD51C/D), measurable disease, and good physical health. They must have already tried platinum-based chemotherapy that didn't work.

Inclusion Criteria

My life expectancy is at least 3 months.
I may or may not have taken a PARP inhibitor before.
I am fully active or can do light work despite my illness.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Lorigerlimab with docetaxel or docetaxel alone, with potential crossover to Lorigerlimab monotherapy upon disease progression

Up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 60 months

What Are the Treatments Tested in This Trial?

Interventions

  • Lorigerlimab

Trial Overview

The study tests lorigerlimab in people with advanced pancreatic cancer and certain genetic mutations. It looks at how well the drug works after other treatments have failed.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Lorigerlimab GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Peter Hosein, MD

Lead Sponsor

Trials
1
Recruited
40+

MacroGenics

Industry Sponsor

Trials
51
Recruited
5,400+

Citations

Lorigerlimab for Pancreatic Cancer · Info for Participants

The purpose of this study is to determine the objective response rate (ORR) to lorigerlimab in patients with refractory pancreatic ductal adenocarcinoma ...

NCT05293496 | A Study of MGC018 in Combination With ...

The study is designed to characterize safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics, and preliminary antitumor activity.

FDA Issues Partial Clinical Hold on Lorigerlimab Trial in ...

Thus far, 41 patients have been enrolled in the trial and have received a 6-mg/kg dose of lorigerlimab intravenously every 3 weeks. The study ...

Corporate Presentation - MacroGenics, Inc.

results of efficacy and safety data with respect to product ... Pancreatic Cancer. H-score = 116. 7. 21. 28. 35. 42. 49. 0. 500. 1000. 1500. 2000.

Emerging therapeutic advancements in pancreatic cancer - PMC

Pancreatic cancer has significantly high mortality rate of approximately 90% and a dismal survival rate of 5 years in ~ 15–25% of patients who ...

Lorigerlimab (MGD019) in Patients With Pancreatic ...

The purpose of this study is to determine the objective response rate (ORR) to lorigerlimab in patients with refractory pancreatic ductal ...

757 A phase 1/1b dose escalation and cohort expansion ...

Phase 1 testing of single-agent lorigerlimab (NCT03761017) demonstrated acceptable safety in 43 patients with advanced solid tumors and ...

FDA Lifts Clinical Hold on Lorigerlimab Trial in Ovarian ...

A fourth newly enrolled patient experienced concurrent grade 4 neutropenia and septic shock, which resulted in a grade 5 fatal outcome. Patients ...