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Association details:
| Biomarker: | NFE2L2 mutation |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | sirpiglenastat (DRP-104) (Glutamine antagonist) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
DRACEN PHARMACEUTICAL’S DRP-104 GRANTED U.S. FDA FAST TRACK DESIGNATION FOR THE TREATMENT OF NON-SMALL CELL LUNG CANCER
Published date:
10/27/2020
Excerpt:
Dracen Pharmaceuticals...announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s novel glutamine antagonist DRP-104 for the treatment of advanced, previously treated non-small cell lung cancer (NSCLC) patients whose tumors express mutations in KEAP1, NFE2L2 and/or STK11.
Source:
Title:
First-in-human (FIH) study of DRP-104 as single agent and in combination with atezolizumab in patients with advanced solid tumors.
Excerpt:
...Lesions in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.o At time of enrollment, patients must have progressed on, be intolerant of, decline, or be ineligible for, all available standard of care therapies with proven benefit.Part 2 – dose escalation/phase 2a:Cohort 2: locally advanced or metastatic NSCLC with the presence of a known mutation in KEAP1, NFE2L2 and/or STK11.- The mutational status of KEAP1, NFE2L2, STK11 and KRAS genes will be performed by locally validated DNA tests. ...
Trial ID:
Source:
Title:
Study to Investigate DRP-104 in Adults With Advanced Solid Tumors
Excerpt:
...- Part 2: locally advanced or metastatic NSCLC with KEAP1, NFE2L2 and/or STK11 mutation ; Patients must have received at least a platinum doublet chemotherapy and an anti-PD-(L)1 antibody; Received up to 3 lines of systemic anticancer therapy in the recurrent or metastatic setting...
Trial ID:
