Ontegimod + Chemotherapy for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Patrick Grierson, M.D., Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?

The investigators hypothesize that CD11b agonism reprograms the tumor microenvironment (TME) to overcome resistance to checkpoint immunotherapy in pancreatic ductal adenocarcinoma (PDAC). Therefore, the investigators propose an open label phase I/II clinical trial of Ontegimod with gemcitabine and nab-paclitaxel in unresectable pancreatic ductal adenocarcinoma prior to future studies incorporating anti-PD1 checkpoint immunotherapy.

Research Team

Patrick Grierson, M.D., Ph.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for individuals with metastatic pancreatic ductal adenocarcinoma who have already tried one treatment without success. Participants should be able to perform daily activities with minimal assistance. Specific eligibility details are not provided, but typically include factors like age, overall health, and cancer stage.

Inclusion Criteria

My doctor can safely take a biopsy of my cancer for research.

I've had treatment for advanced pancreatic cancer that didn't work or caused side effects.

I can understand and am willing to sign the consent form, or have someone legally authorized to do so on my behalf.

Exclusion Criteria

I have not had major surgery within the last 28 days.

I have a stomach condition that affects medication absorption.

I have severe nerve pain or numbness.

Treatment Details

Interventions

• Gemcitabine (Anti-metabolites)
• Nab paclitaxel (Anti-tumor antibiotic)
• Ontegimod (Monoclonal Antibodies)

Trial Overview The study tests Ontegimod combined with chemotherapy drugs Gemcitabine and Nab-paclitaxel as a second-line treatment for pancreatic cancer. It's an early-phase trial aiming to see if this combination can make the body's environment less friendly to cancer and improve outcomes.

Participant Groups

Group I: Phase I Dose de-escalation (starting dose): Ontegimod + Gemcitabine + Nab-paclitaxel Experimental Treatment 3 Interventions

Ontegimod is an oral medication taken twice daily on Days 1-21 of each 28-day cycle. The starting dose is 800 mg. Gemcitabine and nab-paclitaxel will be given as per standard of care (intravenous on Days 1, 8, and 15 of each 28-day cycle).

Group II: Phase 2 Experimental Arm: Ontegimod + Gemcitabine + Nab-paclitaxel Experimental Treatment 3 Interventions

Ontegimod is an oral medication taken twice daily on Days 1-21 of each 28-day cycle. The dose will determined during the Phase I portion of the trial. Gemcitabine and nab-paclitaxel will be given as per standard of care (intravenous on Days 1, 8, and 15 of each 28-day cycle).

Group III: Phase 2 Control Arm: Gemcitabine + Nab-paclitaxel Active Control 2 Interventions

Gemcitabine and nab-paclitaxel will be given as per standard of care (intravenous on Days 1, 8, and 15 of each 28-day cycle).

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

David H. Perlmutter

Washington University School of Medicine

Chief Executive Officer since 2015

MD from Washington University School of Medicine

Paul Scheel

Washington University School of Medicine

Chief Medical Officer since 2022

MD from Washington University School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School