Melanoma Clinical Trial

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

Summary

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

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

Signed informed consent by patients ≥ 18 years of age and, assent for patients ≥ 12 up to < 18 years of age
Patients must have radiographically-recurrent or radiographically-progressive disease that is measurable using the appropriate tumor response criteria (e.g. RECIST version 1.1)
Archival tumor tissue (preferably less than 3 years old) or fresh tumor tissue for correlative studies is required
If brain metastases are present, they must have been previously treated and be stable as assessed by radiographic imaging

(Closed to Enrollment) Substudy A-specific inclusion criterion:

Patients must have a report of histologically confirmed diagnosis of melanoma or other solid tumor and a concurrent BRAF fusion, CRAF/RAF1 fusion, or CRAF/RAF1 amplification through a tumor or liquid biopsy as assessed by genomic sequencing, polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), or another clinically accepted molecular diagnostic method recognized by local laboratory or agency.

Substudy B-specific inclusion criterion:

Patients must have a report of histologically confirmed diagnosis of melanoma or other solid tumor and a concurrent MAPK pathway alteration (genomic alterations in RAS, RAF, MEK, or NF1) through a tumor or liquid biopsy as assessed by genomic sequencing, PCR, FISH, or another clinically accepted molecular diagnostic method recognized by local laboratory or agency.

Exclusion Criteria:

Known presence of concurrent activating mutation
Patients with current evidence or a history of central serous retinopathy (CSR), retinal vein occlusion (RVO)

(Closed to Enrollment) Substudy A-specific exclusion criterion:

Prior therapy of any RAS- RAF-, MEK-, or ERK-directed inhibitor therapy

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

168

Study ID:

NCT04985604

Recruitment Status:

Recruiting

Sponsor:

Day One Biopharmaceuticals, Inc.

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There are 9 Locations for this study

See Locations Near You

The Angeles Clinic
Los Angeles California, 90025, United States
Hoag Health
Newport Beach California, 92663, United States
University of Colorado Hospital
Aurora Colorado, 80045, United States
Cancer Specialists of North Florida
Jacksonville Florida, 32256, United States
Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States
Community North Cancer Center
Indianapolis Indiana, 46250, United States
OHSU Knight Cancer Institute
Portland Oregon, 97239, United States
UPMC Hillman Cancer Center
Pittsburgh Pennsylvania, 15213, United States
Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37232, United States
Monash Medical Centre
Clayton Victoria, , Australia
Antwerp University Hospital
Edegem , , Belgium
Princess Margaret Cancer Centre
Toronto Ontario, , Canada
The Hospital for Sick Children
Toronto Ontario, , Canada
Hopital de La Timone - APHM
Marseille Bouches-du-Rhône, , France
Dong-A University Hospital
Busan , , Korea, Republic of
Asan Medical Center
Seoul , , Korea, Republic of
Samsung Medical Center
Seoul , , Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , , Korea, Republic of
Hospital Clinic Barcelona
Barcelona , , Spain
Hospital Universitari Vall d'Hebron
Barcelona , , Spain
Hospital Universitario Ramón y Cajal
Madrid , , Spain

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

168

Study ID:

NCT04985604

Recruitment Status:

Recruiting

Sponsor:


Day One Biopharmaceuticals, Inc.

How clear is this clinincal trial information?

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