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Also known as Oral [14C] PF-07799544
PF-07799544 · 2 trials · 14 indications
To characterize the extent of excretion of total radioactivity in urine, feces and vomitus (if any) following administration of a single oral dose of \[14C\]PF-07799544.
To characterize the metabolic profile and identify the circulating and excreted metabolites of PF- 07799544 following administration of a single oral dose of \[14C\]PF-07799544.
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 |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Participants will receive one dose of \[14C\] PF-07799544 by mouth in Period 1. After a washout, participants will receive one dose of PF-07799544 by mouth and one intravenous (IV) infusion of \[14C\] PF-07799544 in Period 2 |
| 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 |
|---|---|---|
| Oral [14C] PF-07799544 | DRUG | A single oral dose of \[14C\] PF-07799544 will be administered as an extemporaneous suspension in Period 1. |
| Oral Unlabeled PF-07799544 | DRUG | A single oral dose of unlabeled PF-07799544 will be administered as extemporaneous solution in Period 2. |
| IV [14C] PF-07799544 | DRUG | A single IV infusion of \[14C\] PF-07799544 will be administered at the approximate Tmax after administration of the unlabeled oral dose of PF-07248144 in Period 2. |
| PF-07799544 | DRUG | Tablet |
| PF-07799933 | DRUG | Tablet |
Inclusion Criteria: Males 18 to 55years of age, inclusive, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead ECGs. BMI of 17.5-32 kg/m2; and a total body weight \>50 kg (110 lb). Exc...
PF-07799544 is an investigational small molecule being studied for use in advanced solid tumors, including melanoma, glioma, thyroid cancer, and non-small cell lung cancer. It is also being studied in healthy male volunteers to understand how the body processes the medicine. PF-07799544 is in Phase 1 clinical development and is not yet approved.
PF-07799544 targets BRAF, a gene that can drive tumor growth when mutated. As a small molecule designed to act on this target, it is being evaluated in cancers such as melanoma and glioma where BRAF alterations are relevant. The drug is in Phase 1 trials to assess its safety and behavior in the body.
PF-07799544 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker PFE. The drug is currently in Phase 1 clinical trials, with studies active but not recruiting participants.
PF-07799544 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Two Phase 1 trials are active but not recruiting: one in patients with advanced solid tumors and one in healthy male volunteers.
PF-07799544 is being studied in two Phase 1 trials. NCT05538130 evaluates the drug as monotherapy or in combination in people with advanced solid tumors, including melanoma and glioma. NCT07578636 is a healthy volunteer study to understand how the body processes the medicine. Both trials are active but not recruiting.
Yes, PF-07799544 is also known as Oral [14C] PF-07799544. The [14C] label indicates a radiolabeled version of the drug used in human absorption, distribution, metabolism, and excretion studies. This form is being tested in healthy male volunteers in trial NCT07578636.