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

Condition(s) studied

Investigational drug(s) / intervention(s)

PF-07799933: Tablet

binimetinib: Tablet

cetuximab: Injection for intravenous use

midazolam: syrup

fluorouracil: Injection for intravenous use

leucovorin: Injection for intravenous use

oxaliplatin: Injection for intravenous use

Study 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.

Eligibility

Primary outcome measure(s)

• Number of participants with dose limiting toxicities (DLTs) (Part 1 and Part 2) — Cycle 1 (21 days)
  DLTs will be evaluated during the first cycle (21 days) as both a single agent or in combination with binimetinib or cetuximab
• Number of participants with treatment-emergent adverse events (AEs) (Part 1 and Part 2) — Baseline to 28 days after last dose of study medication
  AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
• Number of participants with clinically significant change from baseline in laboratory abnormalities (Part 1 and Part 2) — Baseline to 28 days after last dose of study treatment
  Laboratory abnormalities as characterized by type, frequency, severity, and timing
• Number of participants with clinically significant change from baseline in vital sign abnormalities (Part 1 and Part 2) — Baseline to 28 days after last dose of study treatment
  Vital sign abnormalities as characterized by type, frequency, severity, and timing
• Dose interruptions due to AEs (Part 1 and Part 2) — Baseline to 2 years
  Incidence of dose interruptions due to AEs
• Dose dose modifications due to AEs (Part 1 and Part 2) — Baseline to 2 years
  Incidence of dose modifications due to AEs
• Discontinuations due to AEs (Part 1 and Part 2) — Baseline to 2 years
  Incidence of discontinuations due to AEs
• Overall response rate (ORR) (Part 3) — Baseline to 2 years
  Response will be evaluated via radiographical tumor assessments by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
• Number of participants with clinically significant physical exam abnormalities (Part 1 and Part 2) — Baseline to 28 days after last dose of study treatment
  Physical exam abnormalities as as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Trial sites (40)

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