Study on Tovorafenib (DAY101) Alone or with Other Treatments for Melanoma and Other Solid Tumors

Sponsor: Day One Biopharmaceuticals, Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04985604

Provider View

This clinical trial is exploring the use of Tovorafenib, either by itself or combined with other treatments, for patients aged 12 and older with melanoma or other solid tumors that have specific changes in the MAPK pathway, which affects cell growth.

Patient Parameters

Program Overview

This study is testing Tovorafenib, a new treatment, on its own or with other therapies for patients aged 12 and older who have melanoma or other solid tumors that have come back, are getting worse, or are not responding to treatment. These tumors have changes in the MAPK pathway, which is important for cell growth. The study will take place in multiple centers and will include different phases to check the safety and effectiveness of the treatment.

Description

The study includes several parts: a screening period to check if participants qualify, a treatment period where they receive the study drug, a safety follow-up to monitor any side effects, and a long-term follow-up to track their health and any other cancer treatments they receive.

Tovorafenib will be tested alone or with another targeted therapy in different sub-studies. The first phase (Phase 1b) will focus on safety and finding the right dose, while the second phase (Phase 2) will look at how well the treatment works against tumors.

Substudy A (now closed) was for patients with melanoma or other solid tumors that have specific BRAF or CRAF/RAF1 changes.

Substudy B is for patients with melanoma or other solid tumors that have changes in the MAPK pathway, which includes RAS, RAF, MEK, or NF1 genes.

Eligibility Criteria

Inclusion Criteria

  • Patients aged 18 and older must sign a consent form; those aged 12 to under 18 need to give assent.
  • Must have tumors that have come back or are getting worse, and can be measured by scans.
  • Must provide a recent or new tumor sample for study purposes.
  • If cancer has spread to the brain, it must have been treated and stable.

Substudy A (closed) required:

  • A confirmed diagnosis of melanoma or other solid tumor with specific BRAF or CRAF/RAF1 changes.

Substudy B requires:

  • A confirmed diagnosis of melanoma or other solid tumor with changes in the MAPK pathway (RAS, RAF, MEK, or NF1).

Exclusion Criteria

  • Cannot have other active mutations that affect treatment.
  • Cannot have or have had certain eye conditions like central serous retinopathy or retinal vein occlusion.

Substudy A (closed) excluded:

  • Patients who had previous treatments targeting RAS, RAF, MEK, or ERK.

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