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Report for Clinical Trial NCT04585035
 Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene 
      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.
    
NCT04585035  Solid Tumor, Adult  NSCLC  CRC 
  2  Interventions 
 
Name: D-1553
Description: 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.
 Type: Drug
Group Labels:  3  Dose combination of D-1553 with other therapies  Dose escalation of D-1553 monotherapy  Phase 2 of D-1553 monotherapy and combination therapies  
 Name: Other
Description: Standard treatment of solid tumor, NSCLC or CRC
 Type: Drug
Group Labels:  2  Dose combination of D-1553 with other therapies  Phase 2 of D-1553 monotherapy and combination therapies  
  
Primary Outcomes 
 Measure: Subject incidence of Dose-limiting toxicities (DLT) Time: through out the DLT period, approximately 21 days
 Measure: Number of subjects participants with adverse events Time: Through study completion, approximately 3 years
 Measure: 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: Through study completion, approximately 3 years
  
Purpose: Treatment
Allocation: Non-Randomized
Sequential Assignment 
There is one SNP
SNPs
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.. null. --- G12C ---