NCT05497778

A Phase 1b Study of Gemcitabine and Nab-paclitaxel in Combination With IM156 in Patients With Advanced Pancreatic Cancer.

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if adding a new medication, IM156, to treatment with gemcitabine and nab-paclitaxel is safe and tolerable. The ability of this combination to improve the success of this treatment for these patients will also be studied.

Detailed description

Primary Safety Objective: To evaluate the safety and tolerability of IM156 with Gem+NP in patients with metastatic PDAC Exploratory Efficacy Objective: To evaluate the efficacy of IM156 with Gem+NP in patients with metastatic PDAC Exploratory Biomarker Objective: To identify biomarkers that are predictive of response to IM156 (i.e., predictive biomarkers), are associated with progression to a more severe disease state (i.e., prognostic biomarkers), are associated with resistance to IM156, are associated with susceptibility to developing adverse events, can provide evidence of study treatment activity, or can increase the knowledge and understanding of disease biology.

Conditions

• Pancreas Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine	Given by IV (vein)
DRUG	Nab paclitaxel	Given by IV (vein)
DRUG	IM156	Given by PO

Timeline

• Start date: 2022-10-21
• Primary completion: 2027-02-02
• Completion: 2027-02-02
• First posted: 2022-08-11
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study