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OncoMatch/Clinical Trials/NCT05355701

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

Is NCT05355701 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments for melanoma.

Phase 1RecruitingPfizerNCT05355701Data as of Jun 2026Location: United States · Canada · Israel

Treatment: PF-07799933 · binimetinib · cetuximab · midazolam · fluorouracil · leucovorin · oxaliplatinThe 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.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

binimetinibcetuximab

Chemotherapy

fluorouraciloxaliplatin

Other

PF-07799933midazolamleucovorin

Cancer type

Melanoma

Non-Small Cell Lung Carcinoma

Tumor Agnostic

Glioblastoma

Colorectal Cancer

Biomarker criteria

Required: BRAF V600 mutation

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).

Required: BRAF non-V600 Class II BRAF alteration

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).

Required: BRAF non-V600 Class III BRAF alteration

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 stage

Metastatic disease required

Demographics

Ages ≥ 16

Prior therapy

Must have received:

Disease progressed during/following last prior treatment and no satisfactory alternative treatment options

Must have received: BRAF inhibitor

Part 3 (Cohort 1) (BRAF V600 mutant melanoma): Prior BRAF V600 inhibitor therapy required

Must have received: MEK inhibitor

Part 3 (Cohort 1) (BRAF V600 mutant melanoma): prior MEK inhibitor therapy required

Must have received: immune checkpoint inhibitor

Part 3 (Cohort 1) (BRAF V600 mutant melanoma): immune checkpoint inhibitor therapy required

Must have received: cytotoxic chemotherapy (5-FU)

Part 3 (Cohort 4) (BRAF V600E CRC): Minimum of 2 cycles of prior 5-FU based chemotherapy required

Cannot have received: BRAF inhibitor

No prior BRAF inhibitor allowed

Cannot have received: EGFR inhibitor

No prior EGFR inhibitor allowed

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Highlands Oncology Group · Fayetteville, Arkansas
  • Highlands Oncology Group · Rogers, Arkansas
  • Highlands Oncology Group · Springdale, Arkansas
  • Clinical and Translational Research Center (CTRC) · Aurora, Colorado
  • UCHealth Sue Anschutz-Rodgers Eye Center · Aurora, Colorado

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT05355701 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior BRAF inhibitor, EGFR inhibitor disqualifies patients from enrollment.

Does this trial require BRAF?

Yes, BRAF V600 mutation is a required biomarker for enrollment.

Does this trial require BRAF?

Yes, BRAF non-V600 Class II BRAF alteration is a required biomarker for enrollment.

Does this trial require BRAF?

Yes, BRAF non-V600 Class III BRAF alteration is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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