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

NCT05355701

RecruitingPhase 1

Sponsor: Pfizer

Conditions: Melanoma, Non-Small-Cell Lung Cancer, Thyroid Cancer, Glioma, Advanced Colorectal Cancer (Part 1)

Interventions: PF-07799933, binimetinib, cetuximab, midazolam, fluorouracil

Countries: United States, Canada, Israel

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 overview

Sex: ALL

Age: 16 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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).
Locations (40)
  • Fayetteville, Arkansas, United States
  • Rogers, Arkansas, United States
  • Springdale, Arkansas, United States
  • Aurora, Colorado, United States
  • Aurora, Colorado, United States
  • Aurora, Colorado, United States
  • Aurora, Colorado, United States
  • Aurora, Colorado, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Newton, Massachusetts, United States
  • Detroit, Michigan, United States
  • Detroit, Michigan, United States
  • Novi, Michigan, United States
  • Plymouth, Michigan, United States
  • Middletown, New Jersey, United States
  • New York, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Cleveland, Ohio, United States
  • Cleveland, Ohio, United States
  • Portland, Oregon, United States
  • Portland, Oregon, United States
  • Nashville, Tennessee, United States
  • Nashville, Tennessee, United States
  • Nashville, Tennessee, United States
  • Nashville, Tennessee, United States
  • Nashville, Tennessee, United States
  • + 10 more on CT.gov