Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PF-07104091 monotherapy dose escalation
PF-07104091 · 1 trial · 1 indication
Percentage of 14C excreted in urine following 14C PF-07104091 single dose administration will be determined as: (Total 14C urine/ 14C dose administered) \*100 where, 14C dose was administered dose of 14C PF-07104091.
Percentage of 14C excreted in feces following 14C PF-07104091 single dose administration will be determined as: (Total 14C feces/ 14C dose administered) \*100 where, 14C dose was administered dose of 14C PF-07104091.
Percentage of 14C excreted in vomitus (if applicable) following 14C PF-07104091 single dose administration will be determined as: (Total 14C vomitus/ 14C dose administered) \*100 where, 14C dose was administered dose of 14C PF-07104091.
Percentage recovery of total radioactivity (14C) in urine, feces, and vomitus (If applicable) was determined based on total administered dose.
The percentage of major metabolites detected in plasma after oral administration of PF-07104091
The percentage of major metabolites detected in urine after oral administration of PF-07104091
The percentage of major metabolites detected in feces after oral administration of PF-07104091
| Arm | Type | Description |
|---|---|---|
| Regimen A; Period 1 | EXPERIMENTAL | Single oral dose of 14C-labeled PF-07104091 administered under fed conditions. |
| Regimen B; Period 2 | EXPERIMENTAL | Single oral dose of unlabeled PF-07104091 administered under fed conditions followed by an intravenous (IV) infusion of PF-07104091 containing a microdose of 14C-labeled PF-07104091. |
| Name | Type | Description |
|---|---|---|
| PF-07104091 | DRUG | Cyclin-dependent kinase-2 inhibitor |
* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and standard 12-lead ECGs. * Body mass index (BMI) of 17.5-32.0 kg/m2 inclusive and a total body weight \>50 kg (110 lb) * Evidence of a personal...
PF-07104091 is an investigational small molecule being studied for the treatment of Small Cell Lung Cancer, Ovarian Cancer, and Breast Cancer. It is also being evaluated in healthy adults to understand how the body processes the drug. The drug is currently in Phase 1 clinical development.
PF-07104091 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug as a single agent and in combination with other therapies.
PF-07104091 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in early-stage trials to assess its safety, tolerability, and how the body processes it.
PF-07104091 is being studied in two clinical trials. NCT04553133 is a Phase 2 trial evaluating the drug as a single agent and in combination therapy for Small Cell Lung Cancer, Ovarian Cancer, and Breast Cancer. NCT07127770 is a Phase 1 trial in healthy adults to understand how the body processes the drug.
PF-07104091 is the base drug, and the combination of PF-07104091 with PF-07220060 and fulvestrant is a specific treatment regimen being studied in clinical trials. The combination is being evaluated for its potential efficacy in certain cancers, while PF-07104091 alone is also being tested as monotherapy.