Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-07104091 monotherapy dose escalation · 1 trial · 3 indications
Number of participants with DLTs, which are typically Grade 3 or higher adverse events will be summarized by dose level
Type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and any laboratory abnormalities will be summarized by dose level
Identify pulse rate readings that are outside the normal range. The number and percentage of participants who experienced significant pulse rate change from baseline will be summarized by dose level
Identify systolic and diastolic readings that are outside the normal range. The number and percentage of participants who experienced significant blood pressure change from baseline will be summarized by dose level
Determine the effect of the drug on QT prolongation. The number and percentage of participants who experienced QT interval prolongation will be summarized by dose level
Percentage of participants with a best overall response of complete response (CR) or partial response (PR) using RECIST 1.1
| Arm | Type | Description |
|---|---|---|
| PF-07104091 | EXPERIMENTAL | CDK2 monotherapy dose escalation |
| PF-07104091 + palbociclib + fulvestrant | EXPERIMENTAL | CDK2 + palbociclib + fulvestrant |
| PF-07104091 + palbociclib + letrozole | EXPERIMENTAL | CDK2 + palbociclib + letrozole |
| PF-07104091 monotherapy dose expansion (SCLC) | EXPERIMENTAL | PF-07104091 monotherapy dose expansion (SCLC) |
| PF-07104091 monotherapy dose expansion (ovarian) | EXPERIMENTAL | PF-07104091 monotherapy dose expansion (ovarian) |
| PF-07104091 + fulvestrant (post CDK4/6) dose expansion | EXPERIMENTAL | PF-07104091 + fulvestrant (post CDK4/6) dose expansion |
| PF-07104091 + fulvestrant (post CDK 4/6) dose escalation | EXPERIMENTAL | CDK2+ fulvestrant (post CDK 4/6) dose escalation |
| Name | Type | Description |
|---|---|---|
| PF-07104091 monotherapy dose escalation | DRUG | PF-07104091 will be administered orally |
| PF-07104091 + palbociclib + fulvestrant | DRUG | PF-07104091 will be administered orally in combination with palbociclib and fulvestrant |
| PF-07104091 + palbociclib + letrozole | DRUG | PF-07104091 will be administered orally in combination with palbociclib and letrozole |
| PF-07104091 monotherapy dose expansion (ovarian) | DRUG | PF-07104091 will be administered orally |
| PF-07104091 monotherapy dose expansion (SCLC) | DRUG | PF-07104091 will be administered orally |
| PF-07104091 + Fulvestrant (post CDK4/6) | DRUG | PF-07104091 will be administered orally in combination with fulvestrant |
| PF-0704091 + Fulvestrant (post CDK4/6) | DRUG | PF-07104091 + fulvestrant (post 4/6) dose expansion |
Inclusion Criteria: * Participants with HR-positive HER2-negative advanced or metastatic breast cancer (received at least two prior lines in the advanced or metastatic setting including one prior line of combined CDK4/6 inhibitor and endocrine therapy and no more than two prior lines of cytotoxic c...
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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.