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Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
NCT04557449 · View on ClinicalTrials.gov ↗
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 a
Conditions Studied
Interventions
- DRUG Midazolam
- COMBINATION_PRODUCT Enzalutamide
- DRUG PF-07220060
- COMBINATION_PRODUCT Letrozole
- COMBINATION_PRODUCT Fulvestrant
Study Locations (20)
Connecticut
- Smilow Cancer Hospital at Yale - New Haven — New Haven
- Yale-New Haven Hospital-Yale Cancer Center — New Haven
- Smilow Cancer Hospital Phase 1 Unit — New Haven
Massachusetts
- Brigham & Women's Hospital — Boston
- Dana-Farber Cancer Institute — Boston
- Dana Farber Cancer Institute- Chestnut Hill — Newton
Other
- Fundación Respirar — Buenos Aires
- Clínica Universitaria Reina Fabiola — Córdoba
- Fundación CORI para la Investigación y Prevención del Cáncer — La Rioja
Tennessee
- Sarah Cannon Research Institute - Pharmacy — Nashville
- SCRI Oncology Partners — Nashville
California
- Ellison Institute — Los Angeles
Michigan
- START Midwest — Grand Rapids
Texas
- The University of Texas MD Anderson Cancer Center — Houston
Buenos Aires
- Hospital Británico de Buenos Aires — Ciudad Autónoma de Buenos Aires
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 362 participants |
| Start Date | 2020-09-23 |
| Est. Completion | 2027-11-23 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04557449
The ClinicalTrials.gov registry entry for NCT04557449 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 362 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 5 interventions — of which Midazolam is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04557449 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Connecticut, Massachusetts, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04557449 about?
NCT04557449 is a clinical study titled "Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors". 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 monotherap...
What is the current status of trial NCT04557449?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 362 participants. The study started on 2020-09-23. Estimated completion is 2027-11-23.
What conditions does trial NCT04557449 study?
This clinical trial studies the following conditions: Prostate Cancer, Breast Neoplasms, Liposarcoma, Adenocarcinoma of Lung. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04557449?
The interventions under investigation include: Midazolam (DRUG), Enzalutamide (COMBINATION_PRODUCT), PF-07220060 (DRUG), Letrozole (COMBINATION_PRODUCT), Fulvestrant (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04557449?
This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04557449 being conducted?
This trial has 20 study locations across California, Connecticut, Massachusetts, Michigan, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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