Melanoma Clinical Trial

DAY101 Monotherapy or in Combination With Other Therapies for Patients With 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.

DAY101 will be evaluated alone or combined with a different targeted therapy in each sub-study. The Phase1b part of each 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.

View Eligibility Criteria

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 a histologically confirmed diagnosis of tumor with concurrent MAPK pathway alteration as assessed by sequencing, PCR, FISH, or another clinically accepted molecular diagnostic method recognized by local laboratory or regulatory agency
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

Exclusion Criteria:

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

Substudy A-specific exclusion criterion:

Prior therapy with BRAF-, MEK-, or MAPK-directed inhibitor therapy, except for tumor types and indications where such therapy has been approved by the FDA or applicable regulatory authorities

Substudy B-specific exclusion criterion:

Prior receipt of any pan-RAF inhibitor therapy (e.g., LXH254/naporafenib, BGB- 283, BGB-3245, belvarafenib)

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 More Info
Saba Mukarram
Contact
310-231-2181
[email protected]
Hoag Health
Newport Beach California, 92663, United States More Info
Wendy Price
Contact
949-764-4510
[email protected]
Clinical Research Main Line
Contact
949-764-5543
University of Colorado Hospital
Aurora Colorado, 80045, United States More Info
Intake CRC
Contact
[email protected]
Cancer Specialists of North Florida
Jacksonville Florida, 32256, United States More Info
Mary Alice Anderson
Contact
[email protected]
University of Miami Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States More Info
Janet McIntosh
Contact
[email protected]
Community North Cancer Center
Indianapolis Indiana, 46250, United States More Info
Betsy Glowinski
Contact
317-497-2836
[email protected]
OHSU Knight Cancer Institute
Portland Oregon, 97239, United States More Info
Knight Clinical Trials Information Line
Contact
503-494-1080
[email protected]; [email protected]
UPMC Hillman Cancer Center
Pittsburgh Pennsylvania, 15213, United States More Info
Sarah Johnson
Contact
[email protected]
Vanderbilt-Ingram Cancer Center Recruitment and Eligibility Office
Nashville Tennessee, 37232, United States More Info
Contact
800-811-8480
Princess Margaret Cancer Centre
Toronto Ontario, , Canada
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 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.

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