Overview
A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors.
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2027-08-27
2027-08-27
Target enrollment:
0
0
Participant gender:
All
All
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 (called binimetinib and cetuximab) 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, 1 or 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. 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.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
PfizerTreatments:
Cetuximab
Criteria
This study is seeking participants who meet the following 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 and Part 2).
- Tumor specific cohorts (melanoma, colorectal cancer) must have received specific prior
approved therapies
Exclusion Criteria:
- Brain metastasis larger than 4 cm
- Systemic anti-cancer therapy or small molecule therapeutics within 2 weeks prior to
start of study treatment. Antibody based agents within 4 weeks prior to start of study
treatment. Mitomycin C or nitrosoureas within 6 weeks prior to start of study
treatment.
- For participants who may get binimetinib on study, history or current evidence of
retinal vein occlusion (RVO) or concurrent neuromuscular disorder associated with
elevated creatine kinase (CK)