Tovorafenib (DAY101) Monotherapy or in Combination With Other Therapies for Patients With Melanoma and Other Solid Tumors

Colorectal Cancer Clinical Trial

Official title: A Phase 1b/2, Open Label Study of DAY101 Monotherapy or Combination With Other Therapies for Patients With Recurrent, Progressive, or Refractory Solid Tumors Harboring MAPK Pathway Aberrations

Status Recruiting

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. ;

Related Conditions & MeSH terms

• Astrocytoma
• Bladder Cancer
• Bladder Urothelial Carcinoma
• Carcinoma
• Colorectal Cancer
• MEK Mutation
• Melanoma
• Non Small Cell Lung Cancer
• Non-Small Cell Adenocarcinoma
• Pancreatic Acinar Carcinoma
• Pancreatic Neoplasms
• Pilocytic Astrocytoma
• RAS Mutation
• Solid Tumor
• Thyroid Cancer, Papillary

• 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