Tovorafenib (DAY101) or in Combination With Pimasertib for Participants With Melanoma and Other Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-02

Study Completion Date

2024-12-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Melanoma Solid Tumor Pilocytic Astrocytoma Non Small Cell Lung Cancer Colorectal Cancer Pancreatic Cancer MAP Kinase Family Gene Mutation RAS Mutation RAF Mutation MEK Mutation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental Arm

Tovorafenib plus pimasertib

Group Type EXPERIMENTAL

Tovorafenib

Intervention Type DRUG

Tovorafenib tablet for oral use.

Tovorafenib Drug: Pimasertib

Intervention Type DRUG

Tovorafenib tablet for oral use. Pimasertib capsule for oral use

Interventions

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Tovorafenib

Tovorafenib tablet for oral use.

Intervention Type DRUG

Tovorafenib Drug: Pimasertib

Tovorafenib tablet for oral use. Pimasertib capsule for oral use

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No