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Evaluating PF-07248144 for advanced 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

Phase 2 Interventional Pfizer · NCT04606446

This study is testing a new drug called PF-07248144 to see if it can safely help people with advanced solid tumors, like certain types of breast, prostate, and lung cancers.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment320 (estimated)
Ages18 Years and up
SexAll
SponsorPfizer Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations44 sites (Scottsdale, Arizona and 43 other locations)
Trial IDNCT04606446 on ClinicalTrials.gov

What this trial studies

This open-label, multi-center study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-07248144 in patients with advanced or metastatic solid tumors, including specific types of breast, prostate, and lung cancers. The study is divided into two parts: the first part focuses on dose escalation to determine the maximum tolerable dose and recommended dose for expansion, while the second part involves dose expansion cohorts for further evaluation of the drug as a monotherapy and in combination with other treatments. Participants will receive PF-07248144 alone or in combination with fulvestrant, letrozole, palbociclib, or PF-07220060, depending on their specific cancer type and treatment history.

Who should consider this trial

Good fit: Ideal candidates include individuals with locally advanced or metastatic ER+ HER2- breast cancer, castration-resistant prostate cancer, or non-small cell lung cancer who have progressed after prior treatments.

Not a fit: Patients with early-stage cancers or those who have not yet received standard therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that are resistant to standard therapies.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific combination and drug evaluation may offer novel insights.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Scottsdale, Arizona and 43 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Locally Advanced or Metastatic ER+ HER2- Breast CancerLocally Advanced or Metastatic Castration-resistant Prostate CancerLocally Advanced or Metastatic Non-small Cell Lung CancerSolid tumors
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.