This is a phase 1/2, open label study of D-1553 single agent and combination 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 solid tumor with KRasG12C mutation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
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.
Standard treatment of solid tumor, NSCLC or CRC
Research Site
Fresno, California, United States
Subject incidence of Dose-limiting toxicities (DLT)
Time frame: through out the DLT period, approximately 21 days
Number of subjects participants with adverse events
Time frame: Through study completion, approximately 3 years
Plasma concentration of D-1553 as a single agent or in combination with other therapies in subjects wiht advanced or metastatic solid tumors with KRas G12C mutation.
Time frame: Through study completion, approximately 3 years
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Research Site
Orange, California, United States
Research Site
San Francisco, California, United States
Research Site
Louisville, Kentucky, United States
Research Site
Detroit, Michigan, United States
Research Site
New York, New York, United States
Research Site
Portland, Oregon, United States
Research Site
Blacktown, New South Wales, Australia
Research Site
East Albury, New South Wales, Australia
Research Site
Kogarah, New South Wales, Australia
...and 15 more locations