Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05355701

A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With 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

Status
Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
267 (estimated)
Sponsor
Pfizer · Industry
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

Summary

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07799933) administered as a single agent and in combination with other study medicines in people with solid tumors. This study is seeking participants who have an advanced solid tumor with a certain type of abnormal gene called "BRAF" and available treatments are no longer effective in controlling their cancer. All participants in this study will receive PF-07799933. PF-07799933 comes as a tablet to take by mouth, 2 times a day. Depending on the part of the study, participants may also receive another study medicine: * People with melanoma or other solid tumors may also receive binimetinib. Binimetinib comes as a tablet to take by mouth, 2 times a day. * People with colorectal cancer may also receive cetuximab or cetuximab and mFOLFOX6 (Chemotherapy regimen). Cetuximab will be given weekly (or every two weeks) in the clinic as a shot given in the vein or port (intravenous, IV). Participants may receive the study medicines for about 2 years. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.

Conditions

Interventions

TypeNameDescription
DRUGPF-07799933Tablet
DRUGbinimetinibTablet
BIOLOGICALcetuximabInjection for intravenous use
DRUGmidazolamsyrup
DRUGfluorouracilInjection for intravenous use
DRUGleucovorinInjection for intravenous use
DRUGoxaliplatinInjection for intravenous use

Timeline

Start date
2022-07-05
Primary completion
2028-11-02
Completion
2030-05-06
First posted
2022-05-02
Last updated
2026-03-27

Locations

41 sites across 3 countries: United States, Canada, Israel

Regulatory

Source: ClinicalTrials.gov record NCT05355701. Inclusion in this directory is not an endorsement.