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Association details:
| Biomarker: | NOTCH mutation |
|---|---|
| Cancer: | Adenoid Cystic Carcinoma |
| Drug: | AL101 (γ-secretase inhibitor, Notch inhibitor, Notch-2 receptor inhibitor, Notch-3 receptor inhibitor, Notch-4 receptor inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Results of ACCURACY: A phase 2 trial of AL101, a selective gamma secretase inhibitor, in subjects with recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC) harboring Notch activating mutations (Notchmut).
Published date:
05/26/2022
Excerpt:
ACCURACY is an open-label, multicenter phase 2 study of AL101 (4 and 6 mg intravenous QW) in subjects with R/M ACC with Notch1-4mut...Of the 77 evaluable subjects, there were 9 PRs (12%) and 44 SDs (57%) for a disease control rate of 69%...Investigational drug AL101 at both 4 and 6 mg QW appears to be well tolerable in Notchmut R/M ACC.
DOI:
10.1200/JCO.2022.40.16_suppl.6046
Trial ID:
Source:
Title:
904P - ACCURACY: A phase II trial of AL101, a selective gamma secretase inhibitor, in subjects with recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC) harboring Notch activating mutations (Notchmut): Results of 6-mg cohort
Published date:
09/13/2021
Excerpt:
ACCURACY is an open-label, multicenter phase II study of AL101 (4 and 6 mg intravenous QW) in subjects with R/M ACC and known Notch1-4mut (ASCO ‘19, Abstr TPS6098). Subjects require evidence of disease progression within 6 months of entry or newly diagnosed metastatic disease and an ECOG performance status of 0-1. Primary end point was overall response rate (ORR) by RECIST v1.1 (or modified MD Anderson bone criteria), as assessed by investigators. Secondary end points were ORR by central review, duration of response, and safety. The study provides ≥80% power to detect an increase of the ORR from 8% to 25% using a type I error of 5%.AL101 6 mg QW appears to be well tolerated in Notchmut R/M ACC.
Trial ID:
