Study on PF-07248144 for Advanced or Metastatic Solid Tumors
Sponsor: Pfizer
ClinicalTrials ID:NCT04606446
This clinical trial is testing a new drug, PF-07248144, to see if it is safe and effective for treating advanced or metastatic solid tumors. The study will explore how the drug works alone and in combination with other treatments.
Patient Parameters
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Program Overview
The study aims to evaluate the safety and effectiveness of a new drug, PF-07248144, in patients with advanced or metastatic solid tumors. Researchers will test the drug both by itself and in combination with other medications to see how well it works and how the body responds to it.
Description
The study is divided into two main parts. In Part 1, researchers will determine the best dose of PF-07248144 by gradually increasing the dose given to participants. This part is further divided into several sections where the drug is tested alone and in combination with other treatments like fulvestrant, palbociclib, letrozole, and vepdegestrant. In Part 2, the study will expand to include more participants to further evaluate the effectiveness of the drug at the recommended doses identified in Part 1. Participants will receive the drug either alone or in combination with other treatments, depending on the specific section of the study they are in.
Eligibility Criteria
Inclusion Criteria
- Have breast, prostate, or lung cancer that is advanced or has spread to other parts of the body.
- For Part 1A, have breast cancer that is ER+HER2- and has not responded to standard treatments.
- For Parts 1B, 1C, 1D, and 1E, have ER+HER2- breast cancer that has progressed after at least one prior treatment with endocrine therapy and a CDK4/6 inhibitor.
- For Part 2A, have ER+HER2- breast cancer that has progressed after at least one prior treatment with a CDK4/6 inhibitor and endocrine therapy.
- For Part 2B, have ER+HER2- breast cancer that has progressed after at least one prior treatment with a CDK4/6 inhibitor and endocrine therapy, and have not received more than three prior treatments.
- For Part 2D, have ER+HER2- breast cancer that has progressed after at least one prior treatment with a CDK4/6 inhibitor and endocrine therapy, and have not received more than three prior treatments.
- For Part 2E, have ER+HER2- breast cancer that has progressed after at least one prior treatment with a CDK4/6 inhibitor and endocrine therapy, and have not received more than three prior treatments.
- Have a tumor that is ER-positive and HER2-negative based on recent tests.
- Female participants must be willing to undergo medically induced menopause if they are of childbearing potential.
- Have at least one measurable tumor that has not been treated with radiation.
- Be in good overall health with a performance status of 0 or 1.
- Be 18 years or older (20 in Japan, 19 in South Korea).
- Have adequate kidney, liver, and bone marrow function.
- Have recovered from any previous treatments to a certain level of health.
Exclusion Criteria
- Have unmanageable fluid buildup in the abdomen (ascites).
- Have another active cancer within the past three years, except for certain skin cancers or carcinoma in situ.
- Have had major surgery, radiation, or cancer treatment within the past three weeks.
- Have had radiation to more than 25% of the bone marrow.
- Have significant heart problems as shown by an ECG.
- Be on blood thinners, except for certain types that may be allowed.
- Have allergies to the study drug or its ingredients.
- Have active inflammatory bowel disease or other gastrointestinal issues that affect drug absorption.
- Be pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| HonorHealth | 85258 | Scottsdale | Arizona |
| Cedars Sinai Medical Center | 90048 | Los Angeles | California |
| Cedars-Sinai Cancer at Cedars-Sinai Medical Center | 90048 | Los Angeles | California |
| UCSF Medical Center at Mission Bay | 94158 | San Francisco | California |
| Smilow Cancer Hospital at Yale - New Haven | 06510 | New Haven | Connecticut |
| Yale-New Haven Hospital- Yale Cancer Center | 06510 | New Haven | Connecticut |
| Smilow Cancer Hospital Phase 1 Unit | 06511 | New Haven | Connecticut |
| Yale University | 06511 | New Haven | Connecticut |
| Holy Cross Hospital | 33308 | Fort Lauderdale | Florida |
| St. Elizabeth Healthcare | 41017 | Edgewood | Kentucky |
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