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Metastatic Pancreatic Ductal AdenocarcinomaPhase 1/2NCT06904378

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

A Phase 1/2 study testing ONT01, Gemcitabine and Nab paclitaxel in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Washington University School of Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The investigators hypothesize that CD11b agonism reprograms the tumor microenvironment (TME) to overcome resistance to checkpoint immunotherapy in pancreatic ductal adenocarcinoma (PDAC). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ONT01, Gemcitabine and Nab paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteUnited States
Study dates
25 Mar 2026to 30 Sep 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • Absolute neutrophil count ≥ 1.5 K/cumm
  • Platelets ≥ 100 K/cumm
  • Hemoglobin ≥ 9.0 g/dL
  • Total bilirubin ≤ 1.5 x IULN
  • AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN, unless there are liver metastases in which case AST and ALT ≤ 5.0 x IULN
  • Creatinine ≤ 1.5 x IULN or Creatinine clearance > 50 mL/min by Cockcroft-Gault
  • The effects of ONT01 on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 120 days after last dose of ONT01 or 180 days after last dose of nab-paclitaxel/gemcitabine. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s/he must inform her treating physician immediately.
  • Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.

Who cannot join

  • 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 or 2) known indolent malignancies that do not require treatment and will likely not alter the course of treatment of metastatic PDAC (including but not limited to prostate adenocarcinoma Gleason 6 on surveillance, indolent follicular lymphoma on watch and wait surveillance, low risk CLL on surveillance, non-metastatic cutaneous basal cell or squamous cell carcinoma not requiring systemic therapy).
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  • 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.
  • Average QTc >470 msec on screening EKGs.
  • Gastrointestinal condition which could prevent absorption of ONT01, or inability to digest ONT01, in the opinion of the PI or sub-investigator.
  • Clinically significant peripheral neuropathy grade 2 or worse.
  • Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days of C1D1 (phase I portion) or date of randomization (phase II portion).
  • HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.
  • Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.
  • History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.
  • Participants with active, known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, euthyroid participants with a history of Grave's disease (participants with suspected autoimmune thyroid disorders must be negative for thyroglobulin and thyroid peroxidase antibodies and thyroid stimulating immunoglobulin prior to first dose of study treatment), psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll after discussing with the Principal Investigator.
  • Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of C1D1 except for adrenal replacement steroid doses > 10 mg daily prednisone equivalent in the absence of active autoimmune disease. Note: treatment with a short course of steroids (< 5 days) up to 7 days prior to C1D1 (phase I portion) or date of randomization (phase II portion) is permitted. Inhaled intranasal, intra-articular, and topical steroid uses are permitted.
  • Patients with known Gilbert's syndrome.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

557-747-2109

grierson@wustl.edu

United States1 site, 1 recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Patrick Grierson, M.D., Ph.D., 557-747-2109, grierson@wustl.edu

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

    Recruiting

Other trials in United States

About this study

Official title: 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

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.

Being tested
ONT01, Gemcitabine, Nab paclitaxel
Keywords
Pancreatic cancer CD11b, Gemcitabine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ONT01Drug

    Per assigned dose level.

  • GemcitabineDrug

    Also called Gemzar

    The dose of gemcitabine is 1000 mg/m^2.

  • Nab paclitaxelDrug

    Also called Abraxane

    The dose of nab-paclitaxel is 125 mg/m^2.

Study groups in NCT06904378
Study groupRoleWhat they receive
Phase I Dose de-escalation (starting dose): ONT01 + Gemcitabine + Nab-paclitaxelExperimentalONT01 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).
Receives: Drug: ONT01; Drug: Gemcitabine; Drug: Nab paclitaxel
Phase 2 Experimental Arm: ONT01 + Gemcitabine + Nab-paclitaxelExperimentalONT01 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).
Receives: Drug: ONT01; Drug: Gemcitabine; Drug: Nab paclitaxel
Phase 2 Control Arm: Gemcitabine + Nab-paclitaxelActive comparatorGemcitabine and nab-paclitaxel will be given as per standard of care (intravenous on Days 1, 8, and 15 of each 28-day cycle).
Receives: Drug: Gemcitabine; Drug: Nab paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended phase II dose (RP2D) (Phase I only)

    The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle. In the absence of excess toxicity, the maximum tolerated dose will become the recommended phase 2 dose (RP2D).

    Measured: After completion of cycle 1 (each cycle is 28 day) for all Phase I participants (estimated to be 12 months)

  2. Number of participants with dose-limiting toxicities (DLTs) (Phase I only)

    DLTs are defined in the protocol.

    Measured: After completion of cycle 1 (each cycle is 28 days)

  3. Progression-free rate at 6 months (RP2D participants in Phase I and Phase II participants only)

    Measured: At 6 months from start of treatment

Secondary outcomes (5)

  1. Frequency of adverse events (RP2D participants in Phase I and Phase II participants in experimental arm only)

    • The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting.

    Measured: From start of treatment through 30 days after last dose of treatment (estimated to be 7 months)

  2. Objective response rate (ORR) (RP2D participants in Phase I and Phase II participants in experimental arm only)

    • ORR is defined as the proportion of patients with disease control (Complete response + Partial response).
    • Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level.
    • Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Through completion of treatment (estimated to be 6 months)

  3. Progression-free survival (PFS) (RP2D participants in Phase I and Phase II participants in experimental arm only)

    • PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
    • Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

    Measured: Through completion of follow-up (estimated to be 18 months)

  4. Overall survival (OS) (RP2D participants in Phase I and Phase II participants in experimental arm only)

    OS is defined as the duration of time from start of treatment to time of death from any cause. The alive patients are censored at last follow-up date.

    Measured: Through completion of follow-up (estimated to be 18 months)

  5. Disease control rate (DCR) (RP2D participants in Phase I and Phase II participants in experimental arm only)

    • DCR is defined as the proportion of patients with disease control (Complete response + Partial response + Stable Disease) per RECIST 1.1.
    • Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level.
    • Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
    • Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

    Measured: Through completion of follow-up (estimated to be 18 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2025
  2. Study start25 Mar 2026
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Sequential for Phase I portion of trial and parallel for Phase II portion of trial. Participants will be randomized 6:1 to the experimental arm (ONT01/gemcitabine/nab-paclitaxel) vs the control arm (gemcitabine/nab-paclitaxel alone) in the Phase II portion.
Masking
None (open label)
Enrolment
61 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06904378
Sponsor's protocol ID
202508149
Other IDs
P50CA272213
Status last verified
May 2026
First submitted
24 Mar 2025
Last updated
19 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ONT01, Gemcitabine and Nab paclitaxel in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Patrick Grierson, M.D., Ph.D. (557-747-2109, grierson@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended phase II dose (RP2D) (Phase I only) (time frame: After completion of cycle 1 (each cycle is 28 day) for all Phase I participants (estimated to be 12 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06904378.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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