Study of Avutometinib (VS-6766) +Defactinib With Gemcitabine and Nab-paclitaxel in Patients With Pancreatic Cancer (RAMP205)
KRAS Activating Mutation, Metastatic Cancer, Pancreas Cancer
About this trial
This is an interventional treatment trial for KRAS Activating Mutation focused on measuring avutometinib (VS-6766), Metastatic Cancer, KRAS Mutation, Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria: Male or female subjects ≥ 18 years of age Histologic or cytologic evidence of metastatic pancreatic ductal adenocarcinoma. An Eastern Cooperative Group (ECOG) performance status ≤ 1 Measurable disease according to RECIST 1.1 Adequate organ function Adequate cardiac function Agreement to use highly effective method of contraceptive Exclusion Criteria: Patients with pancreatic neuroendocrine tumors Prior or concomitant treatment for metastatic pancreatic ductal adenocarcinoma Prior treatment with inhibitors of the RAS /MAPK pathway [e.g. MEK inhibitors] or inhibitors of FAK History of prior malignancy, with the exception of curatively treated malignancies Major surgery within 4 weeks (excluding placement of vascular access) Concurrent heart disease or severe obstructive pulmonary disease Concurrent ocular disorders Active skin disorder that has required systemic therapy within the past 1 year Patients with interstitial lung disease or pulmonary fibrosis or severe lung disease, pulmonary edema, and adult respiratory distress syndrome Known SARS-Cov2 infection ≤28 days prior to first dose of study therapy
Sites / Locations
- Dana Farber Cancer InstituteRecruiting
- Washington University School of MedicineRecruiting
- Laura & Isaac Perlmutter Cancer Center at NYU Langone HealthRecruiting
- New York Presbyterian/Weill-Cornell Medical CenterRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- University of PennsylvaniaRecruiting
- Virginia Mason Medical CenterRecruiting
- Fred Hutchinson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Gemcitabine + nab-paclitaxel + avutometinib (VS-6766) + defactinib
Gemcitabine + nab-paclitaxel + avutometinib (VS-6766) + defactinib RP2D
To determine the recommended phase 2 dose (RP2D) for gemcitabine Gemcitabine + nab-paclitaxel + avutometinib (VS-6766) + defactinib in patients with untreated metastatic PDAC.
To determine the efficacy of the RP2D identified in Part A in untreated metastatic PDAC patients