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Brief Title: A Trial of YL-13027 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Refractory Metastatic Pancreatic Cancer
Official Title: A Phase 1b Trial of YL-13027 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Refractory Metastatic Pancreatic Cancer
Study ID: NCT06199466
Brief Summary: To learn if the study drug, YL-13027, is safe to give in combination with gemcitabine and nab-paclitaxel to participants with pancreatic cancer.
Detailed Description: Primary Objectives 1. To determine the safety and tolerability of YL-13027 in combination with gemcitabine and nab-paclitaxel in participants with refractory metastatic pancreatic cancer. 2. To determine the objective response rate (ORR) of YL-13027 in combination with gemcitabine and nab-paclitaxel in participants with refractory metastatic pancreatic cancer. Secondary Objectives 1. To evaluate other indicators of the antitumor activity of YL-13027 in combination with gemcitabine and nab-paclitaxel. 2. To evaluate the PK of YL-13027 in combination with gemcitabine and nabpaclitaxel. Exploratory Objectives 1. To evaluate the PD effects of YL-13027 in combination with gemcitabine and nabpaclitaxel. 2. To evaluate biomarkers of response and resistance to YL-13027 in combination with gemcitabine and nab-paclitaxel.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
MD Anderson Cancer Center, Houston, Texas, United States
Name: Jordi Rodon Ahnert, MD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR