Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
PF-07220060: CDK4 inhibitor
Letrozole: Endocrine Therapy
Fulvestrant: Endocrine Therapy
Midazolam: Benzodiazepine used for DDI
Enzalutamide: Androgen Receptor inhibitor
Study summary
This is a Phase 1/2A, open label, multicenter, nonrandomized, multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic study of PF-07220060 administered as a single agent and then in combination with endocrine therapy.
The study consists of two parts and a China and Japan monotherapy cohort. Part 1 includes dose escalation cohorts evaluating PF-07220060 as single agent or in combination with endocrine therapy or enzalutamide, as well as a food effect cohort and a DDI cohort Part 2 includes dose expansion cohorts evaluating PF-07220060 in combination with endocrine therapy or enzalutamide.
In Part 1A, single escalating doses of PF-07220060 alone will be administered to determine the maximum tolerated dose (MTD) and select the recommended dose for expansion In Part 1B and Part 1C, PF-07220060 will be administered in combination with 1 of 2 endocrine therapies (letrozole and fulvestrant, respectively).
In Part 1D, food effect assessment of PF-07220060 at the RP2D dose level from the Part 1A will be conducted In Part 1E, the effect of PF-07220060 on the PK of midazolam will be evaluated (DDI) In Part 1F, escalating dosed of PF-07220060 will be administered in combination with enzalutamide Part 1B and Part 1C may commence at MTD or before reaching the MTD at a dose level in Part 1A.
Part 2A is a dose expansion cohort with fulvestrant and will explore more than one dose of PF-07220060 in participants diagnosed with mBC.
Part 2B and Part 2C are expansion for combination therapy of PF-07220060 with letrozole and fulvestrant, respectively.
Part 2D is the expansion cohort for combination therapy of PF-07220060 with enzalutamide.
Part 2E is an expansion cohort to evaluate PF-07220060 Monotherapy versus PF-07220060 plus fulvestrant combination therapy. The China monotherapy cohort will evaluate safety, tolerability and PK of PF-07220060 administered as single agent in Chinese participants.
The Japan monotherapy cohort will evaluate safety, tolerability and PK of PF-07220060 administered as a single agent in Japanese participants.
Eligibility
Primary outcome measure(s)
- Number of participants with dose limiting toxicities in the Dose Escalation Portion — Baseline up to day 28 of Cycle 1.
First cycle (28 days) dose limiting toxicities (Parts 1A, 1B, 1C, 1F) - Incidence of clinically significant AEs — Weekly during Cycle 1 and 2 and then every 28 days through study completion, up to approximately 24 months; Each cycle is 28 days
Adverse Events - Incidence of clinically significant laboratory assessments — Weekly during Cycle 1 and 2 (each cycle is 28 days) and then every 28 days through study completion, up to approximately 24 months
safety laboratory abnormalities - Incidence of clinically significant abnormal vital and ECG parameters — Day 1, Day 8, Day 15 of Cycle 1 and starting from Cycle 2, and then every 28 days through study completion, up to approximately 24 months (Each cycle is 28 days)
vital signs and heart rate corrected QT interval - Food Effect — Day -7 through the end of Cycle 1
Maximal Concentration, Time to Maximum Plasma Concentration, Area under the Plasma Concentration (Part 1D) - DDI — D1 to the end of Cycle 1
Maximal Concentration, Time to Maximum Plasma Concentration, Area under the Plasma Concentration (Part 1E)
Trial sites (39)
| Facility | City | Region | Status |
|---|---|---|---|
| Ellison Institute | Los Angeles | California | |
| Smilow Cancer Hospital - Yale New Haven Health | New Haven | Connecticut | |
| Yale-New Haven Hospital-Yale Cancer Center | New Haven | Connecticut | |
| Smilow Cancer Hospital Phase 1 Unit | New Haven | Connecticut | |
| Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP | New Haven | Connecticut | |
| Smilow Cancer Hospital - Trumbull | Trumbull | Connecticut | |
| Brigham & Women's Hospital | Boston | Massachusetts | |
| Dana-Farber Cancer Institute | Boston | Massachusetts | |
| Dana Farber Cancer Institute- Chestnut Hill | Newton | Massachusetts | |
| START Midwest | Grand Rapids | Michigan | |
| Sarah Cannon Research Institute - Pharmacy | Nashville | Tennessee | |
| SCRI Oncology Partners | Nashville | Tennessee | |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | |
| The University of Texas, MD Anderson Cancer Center - West Houston | Houston | Texas | |
| Hospital Británico de Buenos Aires | Ciudad Autónoma de Buenos Aires | Buenos Aires | |
| Fundación Cenit Para La Investigación En Neurociencias | CABA | Ciudad Autã³noma de Buenos Aires | |
| Fundación Respirar | Buenos Aires | Argentina | |
| Clínica Universitaria Reina Fabiola | Córdoba | Argentina | |
| Fundación CORI para la Investigación y Prevención del Cáncer | La Rioja | Argentina | |
| Cancer Hospital Chinese Academy of Medical Science | Beijing | Beijing Municipality | |
| Henan Cancer Hospital | Zhengzhou | Henan | |
| Hubei Cancer Hospital | Wuhan | Hubei | |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi’an | Shanxi | |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | |
| Vseobecna fakultni nemocnice v Praze | Prague | Czechia | |
| National Cancer Center Hospital East | Kashiwa | Chiba | |
| COI Centro Oncologico Internacional S.A.P.I. de C.V. | Mexico City | Mexico City | |
| Hospital MAC Periferico Sur | Mexico City | Mexico City | |
| INCAN | Mexico City | Mexico City | |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey | Nuevo León | |
| Hospital Reforma | Oaxaca City | Oaxaca | |
| Oaxaca Site Management Organization | Oaxaca City | Mexico | |
| Onkologicky ustav sv. Alzbety, s.r.o., Interna klinika VSZaSP a OUSA | Bratislava | Slovakia | |
| Narodny onkologicky ustav | Bratislava | Slovakia | |
| Fakultna nemocnica s poliklinikou Nove Zamky | Nové Zámky | Slovakia | |
| Cancer Research UK Edinburgh Centre | Edinburgh | Edinburgh, CITY of | |
| St Bartholomew's Hospital | London | London, CITY of | |
| Sarah Cannon Research Institute UK | London | United Kingdom | |
| The Christie Hospital NHS Foundation Trust | Manchester | United Kingdom |
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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 NCT04557449 on ClinicalTrials.gov ↗ ← All trials in Japan