RecruitingPhase 2NCT04606446

Study of PF-07248144 in Advanced or Metastatic Solid Tumors

A PHASE 1/2A DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC, AND ANTI-TUMOR ACTIVITY OF PF-07248144 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS

Sponsor

Pfizer

Enrollment

320 participants

Start Date

Nov 16, 2020

Study Type

INTERVENTIONAL

Conditions

Locally Advanced or Metastatic ER+ HER2- Breast Cancer Locally Advanced or Metastatic Castration-resistant Prostate Cancer Locally Advanced or Metastatic Non-small Cell Lung Cancer

Summary

This is an open-label, multi center study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-07248144 and early signs of clinical efficacy of PF-07248144 as a single agent and in combination with other agents

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called PF-07248144, alone or combined with other treatments, for people with advanced breast cancer, prostate cancer, or lung cancer that has not responded to standard therapies. **You may be eligible if...** - You have advanced or metastatic breast cancer that is hormone receptor-positive (ER+) and HER2-negative - You have advanced prostate cancer or non-small cell lung cancer (NSCLC) that has not responded to standard treatment - For most parts of the study: your cancer has progressed after at least one prior hormone therapy and a CDK4/6 inhibitor (a common type of targeted therapy) - You are 18 or older and well enough to participate **You may NOT be eligible if...** - You have received more than 3 prior lines of treatment for metastatic disease - You have certain serious heart problems or other significant medical conditions - You are pregnant or breastfeeding - You have had certain other cancers recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPF-07248144

KAT6 Inhibitor

DRUGFulvestrant

Endocrine Therapy

DRUGLetrozole

Endocrine Therapy

DRUGPalbociclib

CDK4/6 Inhibitor

DRUGPF-07220060

CDK4 inhibitor

DRUGPF-07850327, ARV-471, vepdegestrant

PROTAC (PROteolysis Targeting Chimera) ER degrader

Locations(44)

HonorHealth

Scottsdale, Arizona, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Cedars-Sinai Cancer at Cedars-Sinai Medical Center

Los Angeles, California, United States

UCSF Medical Center at Mission Bay

San Francisco, California, United States

Smilow Cancer Hospital at Yale - New Haven

New Haven, Connecticut, United States

Yale-New Haven Hospital- Yale Cancer Center

New Haven, Connecticut, United States

Smilow Cancer Hospital Phase 1 Unit

New Haven, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

St. Elizabeth Healthcare

Edgewood, Kentucky, United States

University Medical Center, lnc.:DBA University of Louisville Hospital

Louisville, Kentucky, United States

University of Louisville

Louisville, Kentucky, United States

UofL Health Brown Cancer Center

Louisville, Kentucky, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

MD Anderson The Woodlands

Conroe, Texas, United States

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

U.T. MD Anderson Cancer Center

Houston, Texas, United States

MD Anderson West Houston

Houston, Texas, United States

MD Anderson League City

League City, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

MD Anderson

Sugar Land, Texas, United States

Swedish Cancer Institute

Seattle, Washington, United States

Swedish Medical Center

Seattle, Washington, United States

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

Cancer Research South Australia

Adelaide, South Australia, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Royal Melbourne Hospital

Parkville, Victoria, Australia

Western Health-Sunshine & Footscray Hospitals

St Albans, Victoria, Australia

St. John of God Subiaco Hospital

Subiaco, Western Australia, Australia

Beijing Cancer hospital

Beijing, Beijing Municipality, China

SUN Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Jilin Province Tumor Hospital

Changchun, Jilin, China

Jilin Province Tumor Hospital

Changchun, Jilin, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Kanagawa cancer center

Yokohama, Kanagawa, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [seoul], South Korea

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [seoul], South Korea

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [seoul], South Korea

Kyungpook National University Chilgok Hospital

Daegu, Taegu-kwangyǒkshi, South Korea

Asan Medical Center

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT04606446

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