RecruitingLocally Advanced or Metastatic ER+ HER2- Breast CancerLocally Advanced or Metastatic Castration-resistant Prostate CancerLocally Advanced or Metastatic Non-small Cell Lung Cancer
Study of PF-07248144 in Advanced or Metastatic Solid Tumors
Eligible age
18+ yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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
Sponsor: Pfizer
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.
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.
Where it's recruiting
Arizona
Scottsdale
California
Los Angeles · San Francisco
Connecticut
New Haven
Florida
Fort Lauderdale
Kentucky
Edgewood · Louisville
Tennessee
Nashville
Texas
Conroe · Houston · League City · San Antonio …
Washington
Seattle
Source: ClinicalTrials.gov · NCT04606446 · last updated 2026-04-16