Study of PF-07248144 in Advanced or Metastatic Solid Tumors

Recruiting now · Phase 2

Conditions studied: 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

In brief

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

Key facts

Study ID

NCT04606446

Run by

Pfizer

People needed

320

Starts

2020-11-16

Expected to finish

2029-08-10

Last updated by the study team

2026-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Asan Medical Center — Seoul, South Korea (enrolling)
• Cedars Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Cedars-Sinai Cancer at Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• UCSF Medical Center at Mission Bay — San Francisco, California, United States (enrolling)
• Smilow Cancer Hospital at Yale - New Haven — New Haven, Connecticut, United States (enrolling)
• Yale-New Haven Hospital- Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
• Smilow Cancer Hospital Phase 1 Unit — New Haven, Connecticut, United States (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• Severance Hospital, Yonsei University Health System — Seoul, Seoul-teukbyeolsi [seoul], South Korea (enrolling)
• Samsung Medical Center — Seoul, Seoul-teukbyeolsi [seoul], South Korea (enrolling)
• Kyungpook National University Chilgok Hospital — Daegu, Taegu-kwangyǒkshi, South Korea (enrolling)
• St. Elizabeth Healthcare — Edgewood, Kentucky, United States (enrolling)
• University Medical Center, lnc.:DBA University of Louisville Hospital — Louisville, Kentucky, United States (enrolling)
• University of Louisville — Louisville, Kentucky, United States (enrolling)
• UofL Health Brown Cancer Center — Louisville, Kentucky, United States (enrolling)
• SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
• MD Anderson The Woodlands — Conroe, Texas, United States (enrolling)
• The University of Texas M. D. Anderson Cancer Center — Houston, Texas, United States (enrolling)
• U.T. MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• MD Anderson West Houston — Houston, Texas, United States (enrolling)
• MD Anderson League City — League City, Texas, United States (enrolling)
• NEXT Oncology — San Antonio, Texas, United States (enrolling)
• MD Anderson — Sugar Land, Texas, United States (enrolling)
• Swedish Cancer Institute — Seattle, Washington, United States (enrolling)
• Swedish Medical Center — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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