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Learning about PF-07799544 in patients with advanced solid tumors

A PHASE 1A/B OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH BRAF-MUTANT MELANOMA AND OTHER SOLID TUMORS

Phase 1 Interventional Pfizer · NCT05538130

This study is testing a new medication called PF-07799544 to see if it can help people with advanced solid tumors who have run out of other treatment options.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment124 (estimated)
Ages16 Years and up
SexAll
SponsorPfizer Industry-sponsored
Locations79 sites (Birmingham, Alabama and 78 other locations)
Trial IDNCT05538130 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and effects of PF-07799544, a new medication, in individuals with advanced solid tumors who have exhausted other treatment options. Participants will take PF-07799544 daily, and some may also receive additional medications like encorafenib, depending on their specific cancer type. The study is divided into different parts, focusing on various solid tumors, including melanoma and those with specific genetic mutations. The goal is to determine the effectiveness of this treatment regimen in managing advanced cancers.

Who should consider this trial

Good fit: Ideal candidates include individuals with advanced or metastatic solid tumors who have not responded to previous treatments and have measurable disease.

Not a fit: Patients with large brain metastases or certain retinal or neuromuscular disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are resistant to current therapies.

How similar studies have performed: Other studies have shown promise with similar approaches targeting BRAF mutations, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 78 other locations

+29 more sites — see ClinicalTrials.gov for the full list.

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 MelanomaGliomaThyroid CancerNon-Small Cell Lung CancerMalignant NeoplasmsBrain NeoplasmsAdvanced or Metastatic Solid TumorsHGG
Last reviewed 2026-06-09 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.