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

Conditions

• Advanced Colorectal Cancer (Part 1)
• Glioma
• Melanoma
• Non-Small-Cell Lung Cancer
• Thyroid Cancer

Eligibility Criteria

Sex

ALL

Age

16 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PF-07799933 — DRUG
  Tablet
• binimetinib — DRUG
  Tablet
• cetuximab — BIOLOGICAL
  Injection for intravenous use
• midazolam — DRUG
  syrup
• fluorouracil — DRUG
  Injection for intravenous use
• leucovorin — DRUG
  Injection for intravenous use
• oxaliplatin — DRUG
  Injection for intravenous use

Study Details

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.

Key Dates

Start date

Jul 5, 2022

Status verified

Jun 2026

Primary completion

Apr 23, 2028

Completion

Oct 25, 2029

Study Design

Enrollment

267 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Monotherapy dose escalation (Part 1)
  Participants will receive PF-07799933
• Experimental: Combination dose escalation (Part 2)
  Participants will receive PF-07799933 in combination with binimetinib or cetuximab
• Experimental: Dose expansion (Part 3) - Tumor and mutation specific Cohort 1
  Participants will receive PF-07799933
• Experimental: Dose expansion (Part 3) - Tumor and mutation specific Cohort 2
  Participants will receive PF-07799933
• Experimental: Dose expansion (Part 3) - Tumor and mutation specific Cohort 3
  Participants will receive PF-07799933
• Experimental: Dose expansion (Part 3) - Tumor and mutation specific Cohort 4
  Participants will receive PF-07799933 in combination with cetuximab
• Experimental: Dose expansion (Part 3) - Tumor and mutation specific Cohort 5
  Participants will receive PF-07799933 in combination with cetuximab and mFOLFOX6 regimen
• Experimental: Dose expansion (Part 3) - Tumor and mutation specific Cohort 6
  Participants will receive PF-07799933
• Experimental: Dose expansion (Part 3) - Tumor and mutation specific Cohort 7
  Participants will receive PF-07799933

Primary Outcome Measure

Number of participants with dose limiting toxicities (DLTs) (Part 1 and Part 2) [ Time Frame: Cycle 1 (21 days) ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (31)

Find similar trials in Fayetteville, AR

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