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Also known as Oral [14C] PF-07799544, Oral Unlabeled PF-07799544, Unlabeled PF-07799544, ARRY-134
PF-07799544 · 1 trial · 13 indications
DLTs will be evaluated during the first cycle (21 days) as a single agent (phase 1a monotherapy) or in combination with other agents (phase 1b dose escalation)
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
Laboratory abnormalities as characterized by type, frequency, severity, and timing.
Vital sign abnormalities as characterized by type, frequency, severity, and timing.
Physical exam abnormalities as as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Response will be evaluated via radiographical tumor assessments by RECIST v1.1 for solid tumors or RANO for primary brain tumors
| Arm | Type | Description |
|---|---|---|
| Phase 1a Monotherapy Dose Escalation | EXPERIMENTAL | Participants will receive PF-07799544 |
| Phase 1b Combination Dose Escalation | EXPERIMENTAL | Participants will receive PF-07799544 and PF-07799933 |
| Phase 1b Combination Dose Expansion | EXPERIMENTAL | Participants will receive PF-07799544 and PF-07799933 |
| Name | Type | Description |
|---|---|---|
| PF-07799544 | DRUG | Tablet |
| PF-07799933 | DRUG | Tablet |
Phase 1b Inclusion Criteria: * Diagnosis of advanced/metastatic solid tumor (excluding colorectal cancer) * Measurable disease by RECIST version 1.1 * Evidence of a BRAF V600 mutation * Prior therapy per tumor cohort * Adequate organ function per protocol Phase 1b Exclusion Criteria: * Other acti...
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PF-07799544 is an investigational oral small molecule being developed by Pfizer, Inc. (PFE) for the treatment of melanoma and other advanced solid tumors. It is a Phase 1 study medicine that has not been approved by the FDA and remains in clinical development.
PF-07799544 is being studied for use in melanoma as part of a Phase 1 program that also includes glioma, thyroid cancer, non-small cell lung cancer, and other advanced or metastatic solid tumors. It is investigational and has not been approved for any indication.
PF-07799544 targets BRAF, a gene that encodes a kinase in the MAPK signaling pathway. The Phase 1 study NCT05538130 is biomarker selected, meaning participants are enrolled based on tumor biomarker characteristics. The drug is administered as monotherapy or in combination.
Pfizer, Inc. (ticker PFE) is developing PF-07799544. The company is running the Phase 1 study NCT05538130, which is evaluating the drug as monotherapy or in combination in people with advanced solid tumors.
PF-07799544 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The single active trial, NCT05538130, is currently active but not recruiting, with an enrollment of 148 participants.
PF-07799544 is being evaluated in the Phase 1 trial NCT05538130, titled a study of PF-07799544 as monotherapy or in combination in people with advanced solid tumors. The trial is active but not recruiting and spans the United States, Australia, Brazil, Canada, China, Israel, and Japan.
Yes. PF-07799544 is also referred to as Oral [14C] PF-07799544, Oral Unlabeled PF-07799544, and Unlabeled PF-07799544. These names describe the labeled and unlabeled oral forms used in the clinical program, and all refer to the same investigational BRAF-targeted small molecule.