This is a Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 Combination Therapy in Subjects with KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
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: Till 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: Till study completion, approximately 3 years
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