Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug targets genetic weakness in tough cancers

NCT ID NCT04985604

Disease control Sponsor: Day One Biopharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested the drug tovorafenib (DAY101) in 23 people aged 12 and older with recurrent or progressive solid tumors that have specific genetic changes in the MAPK pathway. The goal was to see how many patients' tumors shrank or disappeared. The study was terminated early, so the full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tovorafenib (also called DAY101), a targeted cancer drug taken as a tablet by mouth.
What this could lead to
If successful, this drug could offer a new treatment option for certain hard-to-treat cancers with specific genetic changes.
What could go wrong
This was a small, early-phase trial that was terminated, so results are limited. The drug may not work for all tumor types and can cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

23 people

The number who actually took part.

Started

Jul 2021

Finished

Jul 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Signed informed consent by participants ≥ 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 histologically confirmed diagnosis of melanoma or other solid tumor and a BRAF fusion, CRAF/RAF1 fusion, or CRAF/RAF1 amplifications 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-recurrent or radiographically-progressive disease that is measurable using the appropriate tumor response criteria (e.g. RECIST version 1.1 or RANO). * 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: * Prior therapy of any RAS-, RAF-, MEK-, or ERK-directed inhibitor therapy * Known presence of concurrent activating mutation * Participants with current evidence or a history of central serous retinopathy (CSR), retinal vein occlusion (RVO)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Bladder cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

astrocytoma (excluding glioblastoma) bladder transitional cell carcinoma colorectal cancer colorectal neoplasm familial pancreatic carcinoma lung adenocarcinoma melanoma neoplasm non-small cell lung carcinoma pancreatic neoplasm pilocytic astrocytoma spitzoid melanoma Thyroid Cancer, Papillary thyroid gland papillary carcinoma urinary bladder carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bladder cancer Bladder urothelial carcinoma BRAF fusion BRAF gene fusion Colorectal cancer Craf fusion Craf gene amplification Craf gene fusion Map kinase family gene mutation Melanoma Non-small cell adenocarcinoma Non-small cell lung cancer Pancreatic acinar carcinoma Pilocytic astrocytoma Pilocytic astrocytoma, adult Raf mutation RAF1 fusion RAF1 gene amplification RAF1 gene fusion Solid tumor Spitzoid malignant melanoma Spitzoid melanoma Thyroid cancer, papillary

Contacts and locations

Locations

  • Antwerp University Hospital

    Edegem, Belgium

  • Asan Medical Center

    Seoul, South Korea

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256, United States

  • Community North Cancer Center

    Indianapolis, Indiana, 46250, United States

  • Dong-A University Hospital

    Busan, South Korea

  • Hoag Health

    Newport Beach, California, 92663, United States

  • Hopital de La Timone - APHM

    Marseille, Bouches-du-Rhône, France

  • Hospital Clinic Barcelona

    Barcelona, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, Spain

  • Monash Medical Centre

    Clayton, Victoria, Australia

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239, United States

  • Princess Margaret Cancer Centre

    Toronto, Ontario, Canada

  • Samsung Medical Center

    Seoul, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, South Korea

  • The Angeles Clinic

    Los Angeles, California, 90025, United States

  • The Hospital for Sick Children

    Toronto, Ontario, Canada

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Colorado Hospital

    Aurora, Colorado, 80045, United States

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.