Study of PF-07248144 for Advanced Solid Tumors
This study is testing a new drug called PF-07248144, which is a KAT6 inhibitor (a type of medicine that blocks a specific protein involved in cancer growth). It's being studied alone and in combination with other approved cancer medicines like Fulvestrant, Letrozole, Palbociclib, and another drug called PF-07220060. The study is for people with advanced or metastatic (spread to other parts of the body) ER+ HER2- breast cancer, castration-resistant prostate cancer, or non-small cell lung cancer. The main goals are to see how safe PF-07248144 is, what side effects it might cause, and to find the right dose. It will also look for early signs that the treatment is working. The study is currently recruiting up to 320 participants.
- Study design
- This is an open-label study, meaning both you and your doctors will know which treatment you are receiving. It involves multiple parts to find the best dose and then expand to more participants, with a planned enrollment of 320 people.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- For participants in the dose escalation arms, safety will be monitored for up to 24 months.
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NCT04606446
Study of PF-07248144 in Advanced or Metastatic Solid Tumors
Recruiting
PHASE2Ages 18+InterventionalTreatmentPfizer
~320 participants
Updated 2026-04-16 on ClinicalTrials.gov
What's tested:PF-07248144FulvestrantLetrozolePalbociclibPF-07220060PF-07850327, ARV-471, vepdegestrant
At a glance
Recruiting sites
41 of 44 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with dose-limiting toxicities in the Dose Escalation Arms.
Measured over Up to 29 days
+4 more outcomes measured
Conditions
Where it's being run
44 sites across 24 statesTexas7
Connecticut4
Kentucky4
California3
Victoria3
Seoul-teukbyeolsi [seoul]3
Washington2
Jilin2
Study leadership
- Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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):
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
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.
What this trial measures
- Number of participants with dose-limiting toxicities in the Dose Escalation Arms.Up to 29 days
Dose-limiting toxicities (DLTs)
- Safety and Tolerability as assessed by adverse event monitoring for participants enrolled in the Dose Escalation Arms.Up to 24 months
Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
- Safety and Tolerability through monitoring of laboratory assessments for participants enrolled in the Dose Escalation Arms.Up to 24 months
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.
- Safety and Tolerability as assessed by adverse event monitoring for participants enrolled in the Dose Expansion ArmsUp to 24 months
Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
- Safety and Tolerability through monitoring of laboratory assessments for participants enroled in the Dose Expansion ArmsUp to 24 months
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.