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MAPK Pathway Inhibitor
Tovorafenib + Pimasertib for Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Day One Biopharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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, PCR, FISH, or another clinically accepted molecular diagnostic method recognized by local laboratory or agency.
If brain metastases are present, they must have been previously treated and be stable as assessed by radiographic imaging
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights
Study Summary
This trial is testing a new treatment for cancer that targets a patient's specific genetic makeup.
Who is the study for?
This trial is for people aged 12 and older with certain types of cancer, like melanoma or colorectal cancer, that have specific genetic changes in the MAPK pathway. They must have measurable disease progression and provide a tissue sample. It's not for those who've had prior treatment targeting the RAS-RAF-MEK-ERK pathway or have certain eye conditions.Check my eligibility
What is being tested?
The study tests Tovorafenib alone or combined with Pimasertib on patients with solid tumors having alterations in the MAPK pathway. This includes different substudies focusing on various genetic mutations related to this pathway.See study design
What are the potential side effects?
Potential side effects may include typical reactions to targeted cancer therapies such as skin rash, fatigue, gastrointestinal issues (like diarrhea), liver enzyme elevation, vision problems, and possibly high blood pressure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer diagnosis is confirmed and has a BRAF or CRAF/RAF1 change.
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My brain metastases have been treated and are stable.
Select...
My cancer diagnosis is confirmed and it has a MAPK pathway alteration.
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My cancer has grown or returned and can be measured by scans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1b: Determine the MTD and RP2D of tovorafenib in combination with other therapies
Phase 1b: Determine the safety of tovorafenib in combination with other therapies
Phase 2: Evaluate the efficacy of tovorafenib monotherapy or in combination with other therapies
Secondary outcome measures
Phase 1b & 2: Assess additional efficacy parameters of tovorafenib alone and in combination with other therapies
Phase 1b & 2: Characterize the pharmacodynamic (PD) profile of tovorafenib alone and in combination with other therapies
Phase 1b & 2: Characterize the pharmacokinetic (PK) profile of tovorafenib alone and in combination with other therapies
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm #2Experimental Treatment2 Interventions
Tovorafenib plus pimasertib
Group II: Arm #1 (Closed to Enrollment)Experimental Treatment1 Intervention
Tovorafenib monotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pimasertib
2021
Completed Phase 2
~380
Find a Location
Who is running the clinical trial?
Day One Biopharmaceuticals, Inc.Lead Sponsor
6 Previous Clinical Trials
722 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or had eye conditions like CSR or RVO.I have never been treated with RAS, RAF, MEK, or ERK inhibitors.I have signed the consent form and am 18 or older, or I am 12-17 and have given my assent.My cancer diagnosis is confirmed and has a BRAF or CRAF/RAF1 change.I can provide recent or new tumor tissue samples for study.My brain metastases have been treated and are stable.My cancer diagnosis is confirmed and it has a MAPK pathway alteration.My cancer has grown or returned and can be measured by scans.My cancer has a known activating mutation.
Research Study Groups:
This trial has the following groups:- Group 1: Arm #1 (Closed to Enrollment)
- Group 2: Arm #2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In which areas is this clinical experiment being conducted?
"The study is currently open at 10 different sites, which includes locations in Pittsburgh, Newport Beach and Aurora. To reduce travel requirements when enrolling, it might be best to select the site closest to you."
Answered by AI
Is enrollment open for this experiment at the present time?
"Confirmed, this clinical trial is open for recruitment based on information posted to clinicaltrials.gov. The study was initiated July 15th 2021 and last revised November 2nd 2022."
Answered by AI
What is the aggregate population participating in this clinical experiment?
"Affirmative. The clinical trials website reveals that this research trial, which was first advertised on July 15th 2021, is still open for participants. They are recruiting 168 individuals from 10 distinct medical sites."
Answered by AI
What is the ultimate purpose of this medical investigation?
"Over the course of up to 48 months, this trial will assess DAY101's efficacy as a monotherapy. Additionally, researchers are looking into its pharmacodynamic profile by measuring changes from baseline in phosphorylated ERK and other biomarkers. The safety and tolerability of DAY101 is being evaluated through treatment-emergent adverse events and laboratory abnormalities. Lastly, tumor responses observed with Day 101 such as time to response for those with complete or partial remission are also being compared against DOR outcomes from prior lines of anticancer treatments."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
What site did they apply to?
OHSU Knight Cancer Institute
UPMC Hillman Cancer Center
Princess Margaret Cancer Centre
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
What questions have other patients asked about this trial?
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