The main purpose of the study is to evaluate the safety of GDC-1971 in combination with either osimertinib or cetuximab. The study consists of a dose-finding stage followed by an expansion stage.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
GDC-1971 capsules or tablets will be administered as specified in each treatment arm.
Osimertinib tablets will be administered as specified in each treatment arm.
Cetuximab, solution for infusion will be administered as specified in each treatment arm.
SCRI Oncology Partners
Nashville, Tennessee, United States
START South Texas Accelerated Research Therapeutics-San Antonio
San Antonio, Texas, United States
Border Medical Oncology
Wodonga, New South Wales, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Seoul National University Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Percentage of Participants with Adverse Events (AEs) Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Time frame: Up to approximately 41 months
Number of Participants with Dose-Limiting Toxicities (DLTs)
Time frame: Day 1 through Day 28 of Cycle 1 (1cycle= 28 days)
Plasma Concentration of GDC-1971
Time frame: Up to approximately 41 months
Plasma Concentration of Osimertinib
Time frame: Up to approximately 41 months
Objective Response Rate (ORR) as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
Time frame: Up to approximately 41 months
Duration of Response (DOR) as Determined by Investigator According to RECIST v1.1
Time frame: Up to approximately 41 months
Progression-Free Survival (PFS) After Enrollment as Determined by Investigator According to RECIST v1.1
Time frame: Up to approximately 41 months
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