Tovorafenib (DAY101) or in Combination With Pimasertib for Participants With Melanoma and Other Solid Tumors
This is a subprotocol of Master Protocol DAY101-102 and is a Phase 1b/2, multi-center, open label subprotocol of participants ≥12 years of age, with recurrent or progressive solid tumors with alterations in the key proteins of the MAPK pathway, such as tumors that harbor RAS or RAF alterations. \*Note: Study concluded as Phase 1b only.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Aug 14, 2025 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Day One Biopharmaceuticals, Inc.
- Interventions being studied
- Drug: Tovorafenib; Drug: Tovorafenib Drug: Pimasertib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Signed informed consent by participant ≥12 years of age; either a Consent or an Assent Form will be provided to the patient based on their capacity, local regulations, and guidelines.
- Participants must have a report of histologically confirmed diagnosis of tumor and a concurrent MAPK pathway alteration (genomic alterations in RAS, RAF, MEK, or NF1) obtained 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 regulatory agency
- Participants must have radiographically stable, recurrent or progressive disease that is measurable using the appropriate tumor response criteria eg, (RECIST version 1.1, RANO)
- Archival tumor tissue should be preferably less than 3 years old. If unavailable, a freshly acquired tumor tissue biopsy or liquid biopsy is required
- If brain metastases are present, they must have been previously treated and be stable as assessed by radiographic imaging
- Known presence of concurrent activating alterations
- Participants with current evidence or a history of serous retinopathy (SR), retinal vein occlusion (RVO) or ophthalmopathy present at screening or baseline who would be considered at risk for SR or RVO
- Participants who have an unstable neurological condition, despite adequate treatment (eg, uncontrolled seizures)
- Participants with history of acute neurological events (such as intracranial or subarachnoid hemorrhage, stroke, intracranial trauma) within the past 6 months
- History of second malignancy within 3 years prior to study treatment except for curatively treated cervical cancer in situ, non-melanoma skin cancer, or superficial bladder cancer
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- The Angeles ClinicLos Angeles, California
- Hoag HealthNewport Beach, California
- University of Colorado HospitalAurora, Colorado
- Cancer Specialists of North FloridaJacksonville, Florida
- Community North Cancer CenterIndianapolis, Indiana
- OHSU Knight Cancer InstitutePortland, Oregon
- UPMC Hillman Cancer CenterPittsburgh, Pennsylvania
- vanderbilt-Ingram Cancer CenterNashville, Tennessee
- Princess Margaret Cancer CentreToronto, Ontario
- The Hospital for Sick ChildrenToronto, Ontario
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 14, 2025. Always confirm current availability with the study team.