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New pill shows promise for Hard-to-Treat cancers with BRAF mutation

NCT ID NCT05355701

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 8 times

Summary

This early-stage trial is testing a new oral drug, PF-07799933, in people aged 16 and older with advanced solid tumors that have a specific BRAF gene change. The drug is given alone or combined with other medicines like binimetinib or cetuximab. The study aims to find safe doses and see if the drug can shrink tumors. About 267 participants will be enrolled.

What this could mean

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

Active substance
PF-07799933 (ARRY-440) tablet, taken twice daily, alone or with binimetinib, cetuximab, or chemotherapy
What this could lead to
If successful, this could lead to a new treatment option for people with advanced solid tumors that have a BRAF gene change and have stopped responding to other therapies.
What could go wrong
This is an early Phase 1 trial focused mainly on safety and dosing, so it is too soon to know if the drug will effectively shrink tumors. Side effects are possible and will be closely monitored.

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

103 people

The number who actually took part.

Started

Jul 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.

This study is seeking participants who meet the following key eligibility criteria: Inclusion Criteria: * Diagnosis of advanced/metastatic solid tumor including primary brain tumor. * Qualifying BRAF alteration (V600 or non-V600 Class II/Class III BRAF alteration), in tumor tissue and/or blood (ie circulating tumor deoxyribonucleic acid \[DNA\], or ctDNA). * Disease progressed during/following last prior treatment and no satisfactory alternative treatment options (Part 1, Part 2 (doublet), and Part 3 (cohorts 2, 3, 6, 7)). * Tumor specific cohorts (melanoma, colorectal cancer) must have received specific prior approved therapies * Part 3 (Cohort 1) (BRAF V600 mutant melanoma): Prior BRAF V600 inhibitor therapy required, prior MEK inhibitor therapy required, and immune checkpoint inhibitor therapy required. * Part 3 (Cohort 4) (BRAF V600E CRC): Minimum of 2 cycles of prior 5-FU based chemotherapy required. No prior BRAF inhibitor/EGFR inhibitor allowed. Participants with MSI-H/dMMR mCRC should receive prior immune checkpoint inhibitor therapy. * Part 3 (Cohort 5) (BRAF V600E CRC): No more than 2 cycles of prior 5-FU based chemotherapy allowed. No prior BRAF inhibitor/EGFR inhibitors allowed. Participants with MSI-H/dMMR mCRC should receive prior immune checkpoint inhibitor therapy. Exclusion Criteria: * Brain metastasis larger than 4 cm * Systemic anti-cancer therapy or small molecule therapeutics ongoing at the start of study treatment. * History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO; history of retinal degenerative disease. * Concurrent neuromuscular disorder associated with elevated creatine kinase (CK).

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Conditions

The condition(s) this trial relates to.

colorectal cancer glioma melanoma neoplasm non-small cell lung carcinoma thyroid cancer Thyroid Neoplasms

As listed by the trial registrant

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

Advanced colorectal cancer (part 1) GLIOMA Melanoma Non-small cell lung cancer Thyroid cancer

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Brigitte Harris Cancer Pavilion

    Detroit, Michigan, 48202, United States

  • CT Scan and Echo Only: Henry Ford Medical Center-Plymouth

    Plymouth, Michigan, 48170, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Cleveland Clinic Taussig Cancer Center Investigational Pharmacy

    Cleveland, Ohio, 44106, United States

  • Clinical and Translational Research Center (CTRC)

    Aurora, Colorado, 80045, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dana-Farber Cancer Institute - Chestnut Hill

    Newton, Massachusetts, 02467, United States

  • Hadassah Medical Center

    Jerusalem, 9112001, Israel

  • Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)

    Detroit, Michigan, 48202, United States

  • Henry Ford Medical Center - Columbus

    Novi, Michigan, 48377, 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

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • MSK David H. Koch Center for Cancer Care

    New York, New York, 10021, United States

  • MSK Monmouth

    Middletown, New Jersey, 07748, United States

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1, Canada

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Cancer Center 53rd street

    New York, New York, 10022, United States

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 1X6, Canada

  • Providence Cancer Institute Franz Clinic

    Portland, Oregon, 97213, United States

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

  • Rambam Health Care Campus

    Haifa, Ḥeifā, 3109601, Israel

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203, United States

  • START San Antonio

    San Antonio, Texas, 78229, United States

  • Sarah Cannon Research Institute - Pharmacy

    Nashville, Tennessee, 37203, United States

  • Sheba Medical Center

    Ramat Gan, 5262000, Israel

  • Sourasky Medical Center

    Tel Aviv, Central District, 6423906, Israel

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136, United States

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6, Canada

  • TriStar Bone Marrow Transplant

    Nashville, Tennessee, 37203, United States

  • TriStar Centennial Medical Center - Cell Processing Lab

    Nashville, Tennessee, 37203, United States

  • TriStar Centennial Medical center

    Nashville, Tennessee, 37203, United States

  • UCHealth Sue Anschutz-Rodgers Eye Center

    Aurora, Colorado, 80045, United States

  • University Health Network

    Toronto, Ontario, M5G 2C4, Canada

  • University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

    Aurora, Colorado, 80045, United States

  • University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)

    Aurora, Colorado, 80045, United States

  • University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)

    Aurora, Colorado, 80045, United States

  • University of Miami Hospital and Clinics

    Miami, Florida, 33136, United States

More trials for these conditions

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