Approval Probability
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Also known as PF-07104091 monotherapy dose escalation
PF-07104091 · 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...
Top 1 of 2 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Amgen Inc. | AMGN | 1 | PHASE3 | Tarlatamab |
PF-07104091 is an investigational small molecule oncology drug developed by Pfizer, Inc. (ticker PFE). It is being studied as a single agent and in combination therapy for solid tumors, including small cell lung cancer, ovarian cancer, and breast cancer. It is currently in Phase 2 clinical development and has not been approved for any indication.
PF-07104091 is being evaluated for the treatment of small cell lung cancer, along with ovarian cancer and breast cancer, in a Phase 2 clinical trial. It is an investigational therapy and is not approved for use in small cell lung cancer or any other indication.
PF-07104091 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the clinical program evaluating the drug as a single agent and in combination therapy across several tumor types.
PF-07104091 is in Phase 2 clinical development. The program consists of one active trial that is no longer recruiting participants. The drug remains investigational and has not received FDA approval for any indication.
PF-07104091 is being studied in the Phase 2 trial NCT04553133, titled "PF-07104091 as a Single Agent and in Combination Therapy." The trial has an enrollment of 157 participants and is active but not recruiting. It is being conducted in the United States, Argentina, Bulgaria, and China.
Yes, PF-0704091 is an alternative name used for PF-07104091. The drug is also referenced in combination regimens such as PF-07104091 plus PF-07220060 plus fulvestrant, and PF-0704091 plus fulvestrant in post-CDK4/6 settings, as well as PF-07104091 monotherapy dose escalation.