Actively Recruiting
Phase I/II Trial of ONT01 with Gemcitabine and Nab-paclitaxel as Second-Line Therapy for Metastatic Pancreatic Ductal Adenocarcinoma
Led by Washington University School of Medicine · Updated on 2026-05-19
61
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether ONT01, a medication that targets the tumor environment, can help overcome resistance to checkpoint immunotherapy in people with metastatic pancreatic ductal adenocarcinoma (PDAC) that cannot be removed by surgery. This open-label phase I/II trial evaluates ONT01 combined with standard chemotherapy drugs gemcitabine and nab-paclitaxel as a second-line treatment after disease progression or intolerance to initial therapy. Participants will receive ONT01 orally twice daily on Days 1 to 21 of each 28-day cycle, with doses determined during the phase I portion. Gemcitabine and nab-paclitaxel will be given intravenously on Days 1, 8, and 15 per standard care. The trial has three arms: phase I dose de-escalation with ONT01 plus chemotherapy, phase II experimental arm with ONT01 plus chemotherapy, and phase II control arm with chemotherapy alone. Throughout the study, participants will be monitored for safety and treatment effects including dose-limiting toxicities, progression-free rate at 6 months, adverse events, response rates, and survival outcomes. Assessments will be conducted during and after treatment cycles, with follow-up lasting up to 18 months. The study aims to identify a recommended phase II dose and evaluate the combination therapy's impact on disease control and patient survival.
CONDITIONS
Brief Title
ONT01 and Gemcitabine/Nab-paclitaxel as Second Line Therapy for Metastatic Pancreatic Ductal Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed adenocarcinoma of the pancreas.
- Measurable or evaluable disease per RECIST 1.1.
- Previously treated with first-line systemic therapy for unresectable, advanced, or metastatic PDAC and experienced progression or intolerance.
- At least 18 years of age.
- ECOG performance status of 0 or 1.
- Adequate bone marrow and organ function including specified blood counts and liver/kidney measures.
- Agreement to use adequate contraception during and after the study as specified.
- Ability to understand and willingness to sign informed consent.
You will not qualify if you...
- Received more than one line of treatment or prior gemcitabine or nab-paclitaxel in the metastatic setting, with exceptions for certain adjuvant/neoadjuvant therapies.
- Current or planned use of alternative cancer treatments like holistic or botanical formulations.
- Major surgery within 28 days before treatment start.
- Chemotherapy, targeted therapy, immunotherapy, or radiation within 14 days before treatment start.
- History of other malignancies unless treated and no evidence of disease for at least 2 years or low-risk indolent cancers.
- History of allogeneic organ or stem cell transplant.
- Current use of other investigational agents.
- Known untreated brain metastases; treated brain metastases allowed if stable.
- Allergic reactions to study drugs or similar compounds.
- QTc interval greater than 470 msec on EKG.
- Gastrointestinal issues preventing absorption of ONT01.
- Significant peripheral neuropathy grade 2 or worse.
- Uncontrolled illnesses including active infections or serious heart conditions.
- Pregnant or breastfeeding.
- HIV infection without effective treatment and undetectable viral load.
- Active hepatitis B or C infections unless controlled or cured.
- Active autoimmune diseases except certain stable conditions after discussion.
- Recent use of high-dose systemic corticosteroids or immunosuppressive drugs except allowed exceptions.
- Known Gilbert's syndrome.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive ONT01 orally twice daily on Days 1-21 of each 28-day cycle along with gemcitabine and nab-paclitaxel intravenously on Days 1, 8, and 15 of each cycle as second-line therapy for metastatic pancreatic ductal adenocarcinoma.
3 visits per 28-day cycle (in-person)
Duration - Up to 18 months after treatment completion
Participants are monitored for safety and survival outcomes after treatment ends.
Periodic visits for up to 18 months
Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
P
Patrick Grierson, M.D., Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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