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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 ---