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Clinical Trial Summary

This is a Phase 1b/2, multi-center, open label umbrella study of patients ≥12 years of age with recurrent, progressive, or refractory melanoma or other solid tumors with alterations in the key proteins of the RAS/RAF/MEK/ERK pathway, referred to as the MAPK pathway.


Clinical Trial Description

Study DAY101-102 (master study) and sub-studies will consist of a screening period, a treatment period, a safety follow-up period, and a long-term follow-up period where survival, status and subsequent anticancer therapies are collected. Tovorafenib will be evaluated alone or combined with a different targeted therapy in each sub-study. The Phase 1b part of each applicable sub-study will evaluate the safety of the combination and select the dose for the Phase 2 part. The Phase 2 part of each sub-study will evaluate anti-tumor activity. (Closed to Enrollment) Substudy A will enroll patients with recurrent or progressive melanoma or other solid tumors with BRAF fusion or CRAF/RAF1 fusions or amplification. Substudy B will enroll patients with recurrent or progressive melanoma or other solid tumors with alterations in the key proteins of the MAPK pathway. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04985604
Study type Interventional
Source Day One Biopharmaceuticals, Inc.
Contact Day One Biopharmaceuticals
Phone 650-484-0899
Email clinicaltrials@dayonebio.com
Status Recruiting
Phase Phase 1/Phase 2
Start date July 15, 2021
Completion date December 31, 2025

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