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New pill combo takes on Hard-to-Treat cancers

NCT ID NCT05538130

Disease control Sponsor: Pfizer 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 This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 02, 2026 · Updated 10 times

Summary

This early-stage trial tests two experimental pills (PF-07799544 and PF-07799933) taken twice daily at home by adults with advanced solid tumors that have a specific gene change called BRAF V600. The study aims to find safe doses and see if the drugs can shrink tumors. About 124 participants will be enrolled, and treatment continues as long as it works or side effects are manageable.

What this could mean

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

Active substance
PF-07799544 (ARRY-134) and PF-07799933 (ARRY-440) tablets
What this could lead to
If it works, this could point toward a new treatment option for people with advanced BRAF-mutant cancers that have stopped responding to other therapies.
What could go wrong
This is a very early Phase 1 trial with only 124 participants, so safety and effectiveness are not yet proven. The drug combo may cause side effects or fail to shrink tumors.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

148 people

The number who actually took part.

Started

Nov 2022

Expected to finish

Aug 2027

An estimate. End dates often move.

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

16 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.

Phase 1b Inclusion Criteria: * Diagnosis of advanced/metastatic solid tumor (excluding colorectal cancer) * Measurable disease by RECIST version 1.1 * Evidence of a BRAF V600 mutation * Prior therapy per tumor cohort * Adequate organ function per protocol Phase 1b Exclusion Criteria: * Other active malignancy within 3 years * Presence of leptomeningeal disease * History or current evidence of retinal vein occlusion (RVO) or history of retinal degenerative disease * Concurrent neuromuscular disorder associated with elevated creatine kinase (CK) * Active gastrointestinal disease as defined per protocol * History of interstitial lung disease as defined per protocol

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Conditions

The condition(s) this trial relates to.

brain cancer brain neoplasm cancer colorectal cancer differentiated thyroid carcinoma glioma low grade glioma malignant glioma melanoma metastatic malignant neoplasm neoplasm non-small cell lung carcinoma pediatric high-grade glioma T-cell large granular lymphocyte leukemia thyroid cancer Thyroid Neoplasms

As listed by the trial registrant

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

Advanced or metastatic solid tumors Brain neoplasms Colorectal cancer Differentiated thyroid cancer GLIOMA HGG High grade glioma LGG Low grade glioma Malignant neoplasms Melanoma Non-small cell lung cancer NSCLC (non-small cell lung cancer) Thyroid cancer

Contacts and locations

Locations

  • ANIMI - Unidade de Tratamento Oncologico

    Lages, Santa Catarina, 88501001, Brazil

  • Alberta Health Services and The Governors of The University of Alberta

    Edmonton, Alberta, T6G 2C8, Canada

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Brigitte Harris Cancer Pavilion

    Detroit, Michigan, 48202, United States

  • CUIMC Research Pharmacy

    New York, New York, 10032, United States

  • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus

    Québec, Quebec, G1J 1Z4, Canada

  • Centro de Oncologia - CEON+ - Unidade São Caetano do Sul

    São Caetano do Sul, 09541-270, Brazil

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195, United States

  • Cleveland Clinic Taussig Cancer Center Investigational Pharmacy

    Cleveland, Ohio, 44106, United States

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Columbia University Medical Center - Neurological Institute of New York

    New York, New York, 10032, United States

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • Hadassah Medical Center

    Jerusalem, Jerusalem, 9112001, Israel

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Highlands Oncology Group, PA

    Fayetteville, Arkansas, 72703, United States

  • Highlands Oncology Group, PA

    Rogers, Arkansas, 72758, United States

  • Highlands Oncology Group, PA

    Springdale, Arkansas, 72762, United States

  • IBCC - Núcleo de Pesquisa e Ensino

    São Paulo, 04014-002, Brazil

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • Kansai Medical University Hospital

    Hirakata, Osaka, 573-1191, Japan

  • Keck Hospital of USC

    Los Angeles, California, 90033, United States

  • Keck Medical Center of USC Pasadena

    Pasadena, California, 91105, United States

  • Los Angeles General Medical Center

    Los Angeles, California, 90033, United States

  • MSK Basking Ridge.

    Basking Ridge, New Jersey, 07920, United States

  • MSK Bergen.

    Montvale, New Jersey, 07645, United States

  • MSK Commack.

    Commack, New York, 11725, United States

  • MSK Monmouth.

    Middletown, New Jersey, 07748, United States

  • MSK Nassau.

    Uniondale, New York, 11553, United States

  • MSK Westchester.

    Harrison, New York, 10604, United States

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1, Canada

  • Memorial Sloan Kettering Cancer Center - Main Campus

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Cancer Center 53rd street.

    New York, New York, 10022, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center

    Tampa, Florida, 33612, United States

  • Moffitt McKinley Hospital

    Tampa, Florida, 33612, United States

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577, Japan

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121, United States

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Providence Cancer Institute Franz Clinic

    Portland, Oregon, 97213, United States

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

  • Rabin Medical Center

    Petah Tikva, Central District, 4941492, Israel

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050, Australia

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203, United States

  • Sheba Medical Center

    Ramat Gan, Central District, 5265601, Israel

  • Soroka Medical Center

    Beersheba, Southern District, 8410101, Israel

  • Sunnybrook Research Institute

    Toronto, Ontario, M4N 3M5, Canada

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate (Emergency Back-up only)

    Santa Monica, California, 90404, United States

  • The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate

    Los Angeles, California, 90025, United States

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000, China

  • The Kirklin Clinic of UAB Hospital

    Birmingham, Alabama, 35233, United States

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6, Canada

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35249, United States

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94143, United States

  • UCSF Helen Diller Medical Center at Parnassus Heights

    San Francisco, California, 94143, United States

  • UCSF Medical Center, Investigational Pharmacy

    San Francisco, California, 94158, United States

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • University of Alabama at Birmingham - Phase I Clinical Trials Unit

    Birmingham, Alabama, 35249, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    Madison, Wisconsin, 53718, United States

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792, United States

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

More trials for these conditions

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