PF-07104091 as a Single Agent and in Combination Therapy
Condition(s) studied
Investigational drug(s) / intervention(s)
PF-07104091 monotherapy dose escalation: PF-07104091 will be administered orally
PF-07104091 + palbociclib + fulvestrant: PF-07104091 will be administered orally in combination with palbociclib and fulvestrant
PF-07104091 + palbociclib + letrozole: PF-07104091 will be administered orally in combination with palbociclib and letrozole
PF-07104091 monotherapy dose expansion (ovarian): PF-07104091 will be administered orally
PF-07104091 monotherapy dose expansion (SCLC): PF-07104091 will be administered orally
PF-07104091 + Fulvestrant (post CDK4/6): PF-07104091 will be administered orally in combination with fulvestrant
PF-0704091 + Fulvestrant (post CDK4/6): PF-07104091 + fulvestrant (post 4/6) dose expansion
Study summary
To assess the safety and tolerability of increasing doses of PF-07104091 and to estimate the Maximum Tolerated Dose (MTD) and/or select the Recommended Phase 2 dose (RP2D) for PF-07104091 as a single agent in participants with advanced or metastatic small cell lung, breast and ovarian cancers.
Eligibility
Primary outcome measure(s)
- Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) during first cycle — 28 days
Number of participants with DLTs, which are typically Grade 3 or higher adverse events will be summarized by dose level - To evaluate incidence of treatment emergent adverse events and laboratory abnormalities — From baseline until end of study treatment or study completion (approximately 2 years)
Type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and any laboratory abnormalities will be summarized by dose level - Evaluate pulse rate that is out of normal range and changes in pulse rate as compared to baseline — From baseline until end of study treatment or study completion (approximately 2 years)
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 - Evaluate blood pressure that is out of normal range and changes in blood pressure as compared to baseline — From baseline until end of study treatment or study completion (approximately 2 years)
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 - To evaluate heart rate corrected QT interval and changes in corrected QT interval as compared to baseline — From baseline until end of study treatment or study completion (approximately 2 years)
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 - To evaluate the preliminary antitumor activity of PF-07104091 as a single agent and in combination with palbociclib and in combination with letrozole or fulvestrant or fulvestrant alone by objective response rate (ORR) in dose expansion — From baseline through disease progression or study completion (approximately 2 years)
Percentage of participants with a best overall response of complete response (CR) or partial response (PR) using RECIST 1.1
Trial sites (22)
| Facility | City | Region | Status |
|---|---|---|---|
| Medical Oncology & Hematology Associates DBA Mission Cancer and Blood | Clive | Iowa | |
| Des Moines Oncology Research Association | Des Moines | Iowa | |
| Medical Oncology & Hematology Associates DBA Mission Cancer and Blood | Des Moines | Iowa | |
| Medical Oncology & Hematology Associates DBA Mission Cancer and Blood | Des Moines | Iowa | |
| Norton Hospital | Louisville | Kentucky | |
| Norton Cancer Institute, St. Matthews Campus | Louisville | Kentucky | |
| Norton Cancer Institute, Audubon | Louisville | Kentucky | |
| Norton Brownsboro Hospital | Louisville | Kentucky | |
| Norton Cancer Institute, Brownsboro Campus | Louisville | Kentucky | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| Dana-Farber Cancer Institute - Chestnut Hill | Newton | Massachusetts | |
| Memorial Sloan Kettering Monmouth | Middletown | New Jersey | |
| Memorial Sloan Kettering Cancer Center (IDS Pharmacy) | Long Island City | New York | |
| Laura & Isaac Perlmutter Cancer Center - NYU ACC | New York | New York | |
| NYU Langone Medical Center (Tisch Hospital) | New York | New York | |
| White Plains Hospital | White Plains | New York | |
| UVA Breast Care Center | Charlottesville | Virginia | |
| Centro de Investigaciones Medicas y Desarrollo LC | Buenos Aires | Buenos Aires F.D. | |
| Complex Oncology Center - Plovdiv EOOD | Plovdiv | Bulgaria | |
| Complex Oncology Center - Shumen | Shumen | Bulgaria | |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin Municipality |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04553133 on ClinicalTrials.gov ↗ ← All trials in the USA