drugset / Trial / NCT06904378
ONT01 and Gemcitabine/Nab-paclitaxel as Second Line Therapy for Metastatic Pancreatic Ductal Adenocarcinoma
Phase 1/2
Recruiting
61 enrolled
Washington University School of Medicine
National Cancer Institute (NCI) · collab
RandomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2026-03-25
- Primary completion
- 2028-09-30
- Completion
- 2029-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ONT01 | Small molecule | 800 mg | Oral |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 125 mg/m2 | Intravenous |