Actively Recruiting
ONT01 and Gemcitabine/Nab-paclitaxel as Second Line Therapy for Metastatic Pancreatic Ductal Adenocarcinoma
Led by Washington University School of Medicine · Updated on 2026-03-30
61
Participants Needed
1
Research Sites
183 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
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 ONT01 with gemcitabine and nab-paclitaxel in unresectable pancreatic ductal adenocarcinoma prior to future studies incorporating anti-PD1 checkpoint immunotherapy.
CONDITIONS
Official 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 according to RECIST 1.1.
- Previously treated with first-line systemic therapy for unresectable or metastatic PDAC and experienced progression or intolerance requiring another systemic therapy.
- At least 18 years of age.
- ECOG performance status of 0 or 1.
- Adequate bone marrow and organ function: absolute neutrophil count 21.5 K/cumm, platelets 100 K/cumm, hemoglobin 9.0 g/dL, total bilirubin 1.5 times upper limit of normal (IULN), AST/ALT 2.5 times IULN (or 5.0 times if liver metastases), creatinine 1.5 times IULN or creatinine clearance > 50 mL/min.
- Women of childbearing potential and men must agree to use adequate contraception before and during the study and for specified periods after treatment.
- Ability to understand and sign informed consent or have a legally authorized representative do so.
You will not qualify if you...
- Received more than one prior line of treatment or prior gemcitabine or nab-paclitaxel in the metastatic setting, with exceptions based on timing and setting of prior therapy.
- Current or planned use of alternative or botanical cancer treatments.
- Major surgery within 28 days prior to treatment start.
- Chemotherapy, targeted therapy, immunotherapy, or radiation within 14 days prior to treatment.
- History of other malignancies except certain cured or indolent cancers.
- History of allogeneic organ or stem cell transplant.
- Use of other investigational agents.
- Known untreated brain metastases; treated brain metastases allowed if stable.
- Allergic reactions to ONT01, gemcitabine, nab-paclitaxel, or related compounds.
- QTc interval > 470 msec on ECG.
- Gastrointestinal conditions preventing absorption or digestion of ONT01.
- Significant peripheral neuropathy (grade 2 or worse).
- Uncontrolled illnesses such as active infection or heart problems.
- Pregnant or breastfeeding women; women must have negative pregnancy test.
- Untreated or uncontrolled HIV, hepatitis B, or hepatitis C infections.
- Active autoimmune diseases requiring systemic treatment or high-dose steroids.
- Known Gilbert's syndrome.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here