The purpose of the dose escalation part of the study is to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab; and to determine the recommended dose(s) for expansion (RDFE) of ALN-BCAT as monotherapy and in combination with pembrolizumab. The purpose of the dose expansion part of the of the study is to evaluate the antitumor activity of ALN-BCAT as monotherapy and in combination with pembrolizumab; to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
158
Administered by intravenous (IV) infusion
Administered by intravenous (IV) infusion
Clinical Trial Site
Phoenix, Arizona, United States
RECRUITINGClinical Trial Site
La Jolla, California, United States
RECRUITINGClinical Trial Site
Los Angeles, California, United States
RECRUITINGClinical Trial Site
Jacksonville, Florida, United States
RECRUITINGClinical Trial Site
Atlanta, Georgia, United States
RECRUITINGClinical Trial Site
Chicago, Illinois, United States
RECRUITINGClinical Trial Site
Ann Arbor, Michigan, United States
RECRUITINGClinical Trial Site
Rochester, Minnesota, United States
RECRUITINGClinical Trial Site
New York, New York, United States
RECRUITINGClinical Trial Site
New York, New York, United States
RECRUITING...and 13 more locations
Frequency of Adverse Events (AEs)
Time frame: From the time of first dose of study drug administration to 30-37 days after the last dose
Severity of AEs
Time frame: From the time of first dose of study drug administration to 30-37 days after the last dose
Dose Escalation: Occurrence of Dose-limiting Toxicities (DLTs)
Time frame: From the time of first dose of study drug administration up to 21 days
Dose Expansion: Antitumor Activity as assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: Up to 30-37 Days after the last dose
Concentrations of ALN-BCAT in Plasma
Area Under the Plasma Concentration-time Curve (AUC), Maximum Observed Plasma Concentration (Cmax) Time to Maximum Plasma Concentration (Tmax)
Time frame: Up to the end of the last study drug administration
Percent Change in Gene that Encodes ß-catenin Protein (CTNNB1) Messenger Ribonucleic Acid (mRNA) Expression Comparing Pre- treatment with On-treatment Tumor Samples
Time frame: Up to 30 days
Dose Escalation: Antitumor Activity as assessed by RECIST v1.1
Time frame: Up to 30-37 Days after the last dose
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