Clinical trialPhase 1 / Phase 2Recruiting
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
- Outcome
- Ongoing
- Phase
- Phase 1 / Phase 2
- Status
- Recruiting
- Study type
- Interventional
- Start
- 25 March 2026
- Expected end
- 30 September 2029
- Enrollment
- 61 participants
- Sites
- 1
- Primary outcomes
- Recommended phase II dose (RP2D) (Phase I only); Number of participants with dose-limiting toxicities (DLTs) (Phase I only); Progression-free rate at 6 months (RP2D participants in Phase I and Phase II participants only)
- Sponsor
- Other
- Results posted
- No
- Last update
- 19 May 2026
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Brief summary public domain (ClinicalTrials.gov)
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.