JAB-3312 is a new investigational potent SHP2 inhibitor. In vitro and in vivo pharmacology studies have demonstrated strong inhibitory potency and
antitumor activity of JAB-3312. A combination of KRAS G12C inhibitor and SHP2 inhibitor is considered a promising strategy to address KRAS G12C inhibitor monotherapy resistance and to synergistically
enhance response and tumor regression

One of the main rationale of this Phase 1/2a, multicenter, open-label study is to demonstrate the safety and tolerability of JAB-3312 (SHP2 inhibitor) in combination with  K-RAS GTPase inhibitors (KRASi) in patients with advanced solid tumors. Furthermore, an expansion Phase 2a will be added to explore the safety, tolerability, and preliminary antitumor activity of JAB-3312 at RP2D in combination with sotorasib in patients with KRAS mutated tumors.

Inclusion Criteria:

Advanced NSCLC with KRAS G12C mutation
Received at least one prior systemic therapy
Naïve to KRAS G12C inhibitor treatment
Participants must have at least 1 measurable lesion as defined by RECIST v1.1
Must be able to provide an archived tumor sample
ECOG performance status score of 0 or 1.

Locations
United States, Arizona
Research Site 
Phoenix, Arizona, United States, 85054
Research Site 
Scottsdale, Arizona, United States, 85259
United States, California
Research Site 
Los Angeles, California, United States, 90033
United States, Connecticut
Research Site 
New Haven, Connecticut, United States, 06510
United States, Florida
Research Site 
Jacksonville, Florida, United States, 32224
Research Site 
Orange City, Florida, United States, 32763
United States, Illinois
Research Site 
Chicago, Illinois, United States, 60637
United States, Indiana
Research Site 
Indianapolis, Indiana, United States, 46202
United States, Michigan
Research Site 
Detroit, Michigan, United States, 48202
United States, Minnesota
Research Site 
Rochester, Minnesota, United States, 55902
United States, Missouri
Research Site 
Saint Louis, Missouri, United States, 63130
United States, New York
Research Site 
New York, New York, United States, 10016
United States, Oklahoma
Research Site 
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
Research Site 
Houston, Texas, United States, 77030
United States, Utah
Research Site 
Salt Lake City, Utah, United States, 84112

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04720976