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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06904378
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Metastatic Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ONT01 — DRUG
    Per assigned dose level.
  • Gemcitabine — DRUG
    The dose of gemcitabine is 1000 mg/m\^2.
  • Nab paclitaxel — DRUG
    The dose of nab-paclitaxel is 125 mg/m\^2.

Study Details

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.

Key Dates

Start date
Mar 25, 2026
Status verified
May 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
61 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I Dose de-escalation (starting dose): ONT01 + Gemcitabine + Nab-paclitaxel
    ONT01 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).
  • Experimental: Phase 2 Experimental Arm: ONT01 + Gemcitabine + Nab-paclitaxel
    ONT01 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).
  • Active Comparator: Phase 2 Control Arm: Gemcitabine + Nab-paclitaxel
    Gemcitabine and nab-paclitaxel will be given as per standard of care (intravenous on Days 1, 8, and 15 of each 28-day cycle).

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Patrick Grierson, M.D., Ph.D.
[email protected]
557-747-2109
Patrick Grierson, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
Olivia Aranha, M.D., Ph.D. (SUB_INVESTIGATOR)
James J Sears, M.D. (SUB_INVESTIGATOR)
Kian-Huat Lim, M.D., Ph.D. (SUB_INVESTIGATOR)
Rama Suresh, M.D. (SUB_INVESTIGATOR)
Benjamin Tan, M.D. (SUB_INVESTIGATOR)
Nikolaos Trikalinos, M.D. (SUB_INVESTIGATOR)
David DeNardo, Ph.D. (SUB_INVESTIGATOR)
Esther Lu, Ph.D. (SUB_INVESTIGATOR)

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