This is a phase 1/2, open label study of D-1553 single agent treatment to assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and antitumor activities in subjects with advanced or metastatic NSCLC with KRasG12C mutation
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
225
D-1553 is a novel, targeted KRasG12C inhibitor that is being developed as a potential oral agent for advanced or metastatic solid tumors with KRasG12C mutation.
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Zhejiang Cancer Hospital, Cancer Hospital of the University of Chinese Academy of Sciences,
Hangzhou, Zhejiang, China
Subject incidence of Dose-limiting toxicities (DLT)
Subject incidence of Dose-limiting toxicities (DLT)
Time frame: through out the DLT period, approximately 21 days
Number of subjects participants with adverse events
Number of subjects participants with adverse events
Time frame: Through study completion, approximately 3 years
antitumor activity of D-1553 in subjects with advanced or metastatic NSCLC with KRASG12C mutation
Overall Response Rate (ORR, Complete Response \[CR\] + Partial Response \[PR\])
Time frame: Through study completion, approximately 3 years
Plasma concentration of D-1553
Plasma concentration of D-1553 as a single agent in subjects with advanced or metastatic NSCLC with KRas G12C mutation
Time frame: approximately 6 months
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