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Clinical Trial Summary

This is an open-label, non-controlled study conducted in two parts - Part A (dose escalation) followed by Part B (dose expansion).


Clinical Trial Description

Patients in Part A will have previously treated progressive or metastatic NSCLC, pancreatic, or colorectal cancer, with or without KRAS mutation. Five dose levels will be explored. In dose level 5, only patients with previously-treated NSCLC with KRAS mutation will be included. Patients in Part B must have previously treated NSCLC with confirmed KRAS mutation. Two dose levels will be explored further in Part B. Twenty (20) patients will be enrolled in Part B, with 10 patients enrolled in each of the two cohorts. Once dose level 5 has been confirmed to be safe in Part A (i.e. 0-1 DLT in 6 patients), an additional 4 patients will then be enrolled for a planned total of 24 patients in Part B. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03819387
Study type Interventional
Source Nitto BioPharma, Inc.
Contact
Status Active, not recruiting
Phase Phase 1
Start date March 18, 2019
Completion date August 2024

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