Spots Global Cancer Trial Database for A Phase 1b Study of Gemcitabine and Nab-paclitaxel in Combination With IM156 in Patients With Advanced Pancreatic Cancer.
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Trial Identification
Brief Title: A Phase 1b Study of Gemcitabine and Nab-paclitaxel in Combination With IM156 in Patients With Advanced Pancreatic Cancer.
Official Title: A Phase 1b Study of Gemcitabine and Nab-paclitaxel in Combination With IM156 in Patients With Advanced Pancreatic Cancer.
Study ID: NCT05497778
Conditions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
MD Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: Shubham Pant, MD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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