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Investigating PF-07799933 for patients with advanced solid tumors and BRAF alterations

A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI TUMOR ACTIVITY OF PF-07799933 (ARRY-440) AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 16 YEARS AND OLDER WITH ADVANCED SOLID TUMORS WITH BRAF ALTERATIONS

Phase 1 Interventional Pfizer · NCT05355701

This study is testing a new medication called PF-07799933 to see if it can help people with advanced solid tumors that have certain BRAF gene changes, especially those whose cancer has not improved with other treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment267 (estimated)
Ages16 Years and up
SexAll
SponsorPfizer Industry-sponsored
Drugs / interventionschemotherapy, cetuximab, binimetinib
Locations18 sites (Aurora, Colorado and 17 other locations)
Trial IDNCT05355701 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of PF-07799933, a new medication, in patients with advanced solid tumors that have specific BRAF gene alterations. Participants will receive PF-07799933, which is taken orally twice daily, and may also receive binimetinib or cetuximab depending on their specific cancer type. The study focuses on individuals whose cancer has progressed despite previous treatments and who have no satisfactory alternative options available. The trial will assess the effects of these medications on tumor progression and patient outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with advanced solid tumors, such as melanoma or non-small-cell lung cancer, who have specific BRAF alterations and have exhausted other treatment options.

Not a fit: Patients with brain metastasis larger than 4 cm or those currently undergoing systemic anti-cancer therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that have BRAF alterations.

How similar studies have performed: Other studies targeting BRAF alterations in solid tumors have shown promising results, indicating that this approach is not entirely novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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).

Where this trial is running

Aurora, Colorado and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions MelanomaNon-Small-Cell Lung CancerThyroid CancerGliomaAdvanced Colorectal Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.