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ONT01 and Gemcitabine/Nab-paclitaxel as Second Line Therapy for Metastatic Pancreatic Ductal Adenocarcinoma | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1/PHASE2

ONT01 and Gemcitabine/Nab-paclitaxel as Second Line Therapy for Metastatic Pancreatic Ductal Adenocarcinoma

Phase I/II Clinical Trial of ONT01 and Gemcitabine/Nab-paclitaxel as Second Line Therapy for Metastatic Pancreatic Ductal Adenocarcinoma: Reprogramming Tumor-associated Myeloid Cells

NCT06904378•Washington University School of Medicine

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 became intolerant to the therapy and is in need of another line of systemic therapy in the opinion of the investigator.
•At least 18 years of age.
•ECOG performance status ≤ 1.
•Adequate bone marrow and organ function as defined below:
•* Absolute neutrophil count ≥ 1.5 K/cumm
•* Platelets ≥ 100 K/cumm
•* Hemoglobin ≥ 9.0 g/dL
•* Total bilirubin ≤ 1.5 x IULN
+4 more criteria

Exclusion Criteria

•Received more than one line of treatment or received gemcitabine or nab-paclitaxel in the metastatic setting. Prior therapy in the adjuvant or neoadjuvant therapy will count as a line of treatment if progression occurred less than 6 months after the last dose of systemic therapy. The following exception applies:
•* If treated in the adjuvant or neoadjuvant setting with systemic therapy and progression occurred greater than 6 months after last dose, the adjuvant or neoadjuvant systemic therapy may have included gemcitabine or nab-paclitaxel. If progression occurred within 6 months of the last dose of systemic therapy in the adjuvant or neoadjuvant setting, then that therapy must not have included gemcitabine or nab-paclitaxel.
•Current use or anticipated need for alternative, holistic, naturopathic, or botanical formulations used for the purpose of cancer treatment.
•Major surgery (defined as surgery that requires general anesthesia) within 28 days of C1D1 of ONT01 (phase I portion) or date of randomization (phase II portion).
•Chemotherapy, small molecular directed therapy, immunotherapy, and/or radiation therapy within 14 days of C1 of ONT01 (phase I portion) or date of randomization (phase II portion).
•History of other malignancy with the exception of 1) malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease and 2) known indolent malignancies that do not require treatment and will likely not alter the course of treatment of metastatic PDAC.
•History of allogeneic organ or stem cell transplant.
•Currently receiving any other investigational agents.
•Patients with known, untreated brain metastases. Patients with treated brain metastases are allowed if post-treatment brain-imaging after CNS-directed therapy shows no evidence of progression.
•A history of allergic reactions attributed to compounds of similar chemical or biologic composition to ONT01, gemcitabine, nab-paclitaxel, or other agents used in the study.
+11 more criteria

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Key Dates

Start Date

March 31, 2026

Primary Completion Date

September 30, 2028

Completion Date

September 30, 2029

Last Updated

February 17, 2026

Enrollment

ESTIMATED participants

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma

Interventions

ONT01

DRUG

Gemcitabine

DRUG

Nab paclitaxel

DRUG

Contacts

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

CONTACT

314-747-7689 grierson@wustl.edu

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RECRUITINGPHASE3

Clinical Trial Comparing TQB2868 Injection Combined With Anlotinib Hydrochloride Capsules With Placebo Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

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Metastatic Pancreatic Ductal Adenocarcinoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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ONT01 and Gemcitabine/Nab-paclitaxel as Second Line Therapy for Metastatic Pancreatic Ductal Adenocarcinoma

Inclusion Criteria

Exclusion Criteria

Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors

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