Clinical trialPhase 1Active not recruiting
A Phase 1b Study of Gemcitabine and Nab-paclitaxel in Combination With IM156 in Patients With Advanced Pancreatic Cancer.
- Outcome
- Ongoing
- Phase
- Phase 1
- Status
- Active not recruiting
- Study type
- Interventional
- Start
- 21 October 2022
- Expected end
- 2 February 2027
- Enrollment
- 19 participants
- Sites
- 1
- Primary outcomes
- National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0
- Sponsor
- Other
- Results posted
- No
- Last update
- 7 October 2026
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.