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Clinical Trials in the USA / NCT04606446
Recruiting Phase 2

Study of PF-07248144 in Advanced or Metastatic Solid Tumors

NCT04606446 · tracked via the Priya Life Science USA tracker
Sponsor
Pfizer
Phase
Phase 2
Started
2020-11-16
Last updated
2026-04-16

Condition(s) studied

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

Investigational drug(s) / intervention(s)

PF-07248144FulvestrantLetrozolePalbociclibPF-07220060PF-07850327, ARV-471, vepdegestrant

PF-07248144: KAT6 Inhibitor

Fulvestrant: Endocrine Therapy

Letrozole: Endocrine Therapy

Palbociclib: CDK4/6 Inhibitor

PF-07220060: CDK4 inhibitor

PF-07850327, ARV-471, vepdegestrant: PROTAC (PROteolysis Targeting Chimera) ER degrader

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Disease Characteristics - Breast, Prostate, and Lung Cancer * Part 1A (Monotherapy Dose Escalation) Histological or cytological diagnosis of locally advanced or metastatic ER+HER2- breast cancer, CRPC, or NSCLC that is intolerant or resistant to standard therapy or for which no standard therapy is available. * Part 1B, Part 1C, Part 1D and Part 1E (Combination Dose Escalation) Histological or cytological diagnosis of locally advanced or metastatic ER+HER2- breast cancer. Participants must have progressed after at least 1 prior line of treatment with an endocrine therapy and CDK4/6 inhibitor in the advanced or metastatic setting. * Part 2A (ER+HER2- breast cancer 2L+, monotherapy) Histological or cytological diagnosis of locally advanced or metastatic ER+HER2- breast cancer. Participants must have progressed after at least 1 prior line of CDK4/6 inhibitor and 1 line of endocrine therapy. * Part 2B (ER+HER2- breast cancer 2-4L, combination with fulvestrant) Histological or cytological diagnosis of advanced or metastatic ER+HER2- breast cancer. Participants must have progressive disease after at least 1 prior line of a CDK4/6 inhibitor and at least 1 prior line of endocrine therapy.. Participants must not have received more than 3 prior lines of systemic therapies including up to 1 line of cytotoxic chemotherapy for visceral disease in advanced or metastatic setting; Participants may have but are not required to have prior treatment with fulvestrant. * Part 2D (ER+HER2- breast cancer 2-4L, combination with PF-07220060 (CDK4i) and fulvestrant): Histological or cytological diagnosis of advanced or metastatic ER+HER2- breast cancer. Participants must have progressive disease after at least 1 prior line of a CDK4/6 inhibitor and at least 1 prior line of endocrine therapy. * Participants must have not received more than 3 lines of systemic therapies including up to 1 line of cytotoxic chemotherapy for visceral disease in advanced or metastatic setting; Participants may have but are not required to have prior treatment with fulvestrant. * Part 2E (ER+HER2- breast cancer 2-4L, combination with vepdegestrant): Histological or cytological diagnosis of advanced or metastatic ER+HER2- breast cancer. Participants must have progressive disease after at least 1 prior line of a CDK4/6 inhibitor and at least 1 prior line of endocrine therapy; Participants must have not received more than 3 lines of systemic therapies including up to 1 line of cytotoxic chemotherapy for visceral disease in advanced or metastatic setting; Participants may have received fulvestrant * Participants with ER+HER2- advanced or metastatic breast cancer must have documentation of ER-positive tumor (≥1% positive stained cells) based on most recent tumor biopsy utilizing an assay consistent with local standards. * Participants with ER+HER2- advanced or metastatic breast cancer must have documentation of HER2-negative tumor: HER2-negative tumor is determined as immunohistochemistry score 0/1+ or negative by in situ hybridization (FISH/CISH/SISH/DISH) defined as a HER2/CEP17 ratio \<2 or for single probe assessment a HER2 copy number \<4. * Female participants with ER+HER2- advanced or metastatic breast cancer considered to be of childbearing potential (or have tubal ligations only) must be willing to undergo medically induced menopause by treatment with the approved LHRH agonist such as goserelin, leuprolide or equivalent agents to induce chemical menopause. * Female participants with ER+HER2- advanced or metastatic breast cancer of nonchildbearing potential must meet at least 1 criteria of achieving postmenopausal status. * Participants must have at least 1 measurable lesion as defined by RECIST version 1.1 that has not been previously irradiated. * Eastern Cooperative Oncology Group (ECOG) Performance Status PS 0 or 1 * Female or male patients aged ≥ 18 years (Japan ≥ 20 years) (South Korea ≥ 19 years). * Adequate renal, liver, and bone marrow function. * Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1 except for adverse events (AEs) not constituting a safety risk by investigator judgment. Exclusion Criteria: * Unmanageable ascites (limited medical treatment to control ascites is permitted, but all participants with ascites require review by sponsor's medical monitor). * Participants with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ. * Major surgery, radiation therapy, or systemic anti-cancer therapy within 3 weeks prior to study entry. * Prior irradiation to \>25% of the bone marrow. * ECG clinically relevant abnormalities (eg, QTc \>470 msec, complete LBBB, second/third degree AV block, ST elevation or EKG changes suggesting myocardial infarction or active myocardia ischemia). * Therapeutic anticoagulation. However, low molecular weight heparin is allowed. Vitamin K antagonists or factor Xa inhibitors may be allowed following discussion with the Sponsor. * Known or suspected hypersensitivity or severe allergy to active ingredient/excipients of PF-07248144. * Active inflammatory GI disease, refractory and unresolved chronic diarrhea or previous gastric resection, lap band surgery or other GI conditions and surgeries that may significantly alter the absorption of PF-07248144 tablets. Gastroesophageal reflux disease under treatment is allowed. * Pregnant or breastfeeding female participants.

Primary outcome measure(s)

Trial sites (44)

FacilityCityRegionStatus
HonorHealth Scottsdale Arizona Terminated
Cedars Sinai Medical Center Los Angeles California Recruiting
Cedars-Sinai Cancer at Cedars-Sinai Medical Center Los Angeles California Recruiting
UCSF Medical Center at Mission Bay San Francisco California Recruiting
Smilow Cancer Hospital at Yale - New Haven New Haven Connecticut Recruiting
Yale-New Haven Hospital- Yale Cancer Center New Haven Connecticut Recruiting
Smilow Cancer Hospital Phase 1 Unit New Haven Connecticut Recruiting
Yale University New Haven Connecticut Recruiting
Holy Cross Hospital Fort Lauderdale Florida Terminated
St. Elizabeth Healthcare Edgewood Kentucky Recruiting
University Medical Center, lnc.:DBA University of Louisville Hospital Louisville Kentucky Recruiting
University of Louisville Louisville Kentucky Recruiting
UofL Health Brown Cancer Center Louisville Kentucky Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
MD Anderson The Woodlands Conroe Texas Recruiting
The University of Texas M. D. Anderson Cancer Center Houston Texas Recruiting
U.T. MD Anderson Cancer Center Houston Texas Recruiting
MD Anderson West Houston Houston Texas Recruiting
MD Anderson League City League City Texas Recruiting
NEXT Oncology San Antonio Texas Recruiting
MD Anderson Sugar Land Texas Recruiting
Swedish Cancer Institute Seattle Washington Recruiting
Swedish Medical Center Seattle Washington Recruiting
Chris O'Brien Lifehouse Camperdown New South Wales Terminated
Cancer Research South Australia Adelaide South Australia Recruiting
Peter MacCallum Cancer Centre Melbourne Victoria Recruiting
Royal Melbourne Hospital Parkville Victoria Recruiting
Western Health-Sunshine & Footscray Hospitals St Albans Victoria Recruiting
St. John of God Subiaco Hospital Subiaco Western Australia Recruiting
Beijing Cancer hospital Beijing Beijing Municipality Recruiting
SUN Yat-Sen University Cancer Center Guangzhou Guangdong Recruiting
Jilin Province Tumor Hospital Changchun Jilin Recruiting
Jilin Province Tumor Hospital Changchun Jilin Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi Recruiting
Aichi Cancer Center Hospital Nagoya Aichi-ken Recruiting
National Cancer Center Hospital East Kashiwa Chiba Recruiting
Kanagawa cancer center Yokohama Kanagawa Recruiting
National Cancer Center Hospital Chuo-ku Tokyo Recruiting
Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do Recruiting
Seoul National University Hospital Seoul Seoul-teukbyeolsi [seoul] Recruiting

+ 4 more sites — see the full list on the official registry below.

On this site

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Official registry record

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 NCT04606446 on ClinicalTrials.gov ↗ ← All trials in the USA