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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age16+
SponsorPfizer

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • PF-07799933
  • binimetinib
  • cetuximab
  • midazolam
  • fluorouracil
  • leucovorin
  • oxaliplatin

Treatment groups

267 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Sponsors and collaborators