Suspended

DAY101 and Pimasertib for Solid Tumors with MAPK Pathway Alterations

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Tovorafenib

+ Tovorafenib Drug: Pimasertib

Drug
Who is being recruted

Astrocytoma+34

+ Bronchial Neoplasms

+ Carcinoma, Bronchogenic

Over 12 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: May 2022
See protocol details

Summary

Principal SponsorDay One Biopharmaceuticals, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 2, 2022

Actual date on which the first participant was enrolled.

This clinical trial is focused on testing a combination of two drugs, DAY101 and Pimasertib, for individuals aged 12 and older who are dealing with certain types of solid tumors. These tumors have specific changes, known as alterations, in the MAPK pathway, which includes RAS or RAF alterations. The goal is to find out if this drug combination can be an effective treatment for patients whose tumors have returned, worsened, or not responded to other treatments. This research is important because finding effective treatments for these specific types of tumors can greatly improve patient outcomes and provide new options for those who have limited alternatives. Participants in this study will receive the treatment, which involves taking DAY101 and Pimasertib, and their progress will be closely monitored. The study does not specify how the drugs are administered, but typically in such trials, drugs can be given orally or through injections. Researchers will observe how the tumors respond to the treatment and look for any side effects. Although the study originally planned for multiple phases, it concluded after the first phase (Phase 1b), focusing on assessing the safety and effectiveness of the drug combination in targeting the MAPK pathway alterations.

Official TitleA Phase 1b/2, Subprotocol of DAY101 in Combination With Pimasertib for Patients With Recurrent, Progressive, or Refractory Solid Tumors and MAPK Pathway Aberrations
NCT07121829
Principal SponsorDay One Biopharmaceuticals, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

44 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AstrocytomaBronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungColonic DiseasesDigestive System DiseasesDigestive System NeoplasmsEndocrine System DiseasesEndocrine Gland NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsGliomaIntestinal DiseasesIntestinal NeoplasmsLung DiseasesLung NeoplasmsMelanomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissuePancreatic DiseasesPancreatic NeoplasmsRectal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsSkin DiseasesSkin NeoplasmsThoracic NeoplasmsColorectal NeoplasmsSkin and Connective Tissue DiseasesNeuroectodermal TumorsNeoplasms, NeuroepithelialNevi and MelanomasNeuroendocrine Tumors

Criteria

5 inclusion criteria required to participate
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
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5 exclusion criteria prevent from participating
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
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Tovorafenib plus pimasertib

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 10 locations

Suspended

The Angeles Clinic

Los Angeles, United StatesOpen The Angeles Clinic in Google Maps
Suspended

Hoag Health

Newport Beach, United States
Suspended

University of Colorado Hospital

Aurora, United States
Suspended

Cancer Specialists of North Florida

Jacksonville, United States
Suspended10 Study Centers