OncoMatch/Clinical Trials/NCT04606446
Study of PF-07248144 in Advanced or Metastatic Solid Tumors
Is NCT04606446 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments for locally advanced or metastatic er+ her2- breast cancer.
Treatment: PF-07248144 · Fulvestrant · Letrozole · Palbociclib · PF-07220060 · PF-07850327, ARV-471, vepdegestrant — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Endocrine / hormonal
Other
Cancer type
Breast Carcinoma
Prostate Cancer
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: ESR1 positive (≥1% positive stained cells)
documentation of ER-positive tumor (≥1% positive stained cells) based on most recent tumor biopsy utilizing an assay consistent with local standards
Required: HER2 (ERBB2) wild-type (IHC 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)
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
Disease stage
Metastatic disease required
locally advanced or metastatic ... must have at least 1 measurable lesion as defined by RECIST version 1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine therapy — advanced or metastatic
must have progressed after at least 1 prior line of endocrine therapy
Must have received: CDK4/6 inhibitor — advanced or metastatic
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
Cannot have received: systemic anti-cancer therapy
Exception: within 3 weeks prior to study entry
systemic anti-cancer therapy within 3 weeks prior to study entry
Cannot have received: cytotoxic chemotherapy
Exception: no more than 1 line for visceral disease in advanced or metastatic setting
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
Lab requirements
Blood counts
adequate bone marrow function
Kidney function
adequate renal function
Liver function
adequate liver function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- HonorHealth · Scottsdale, Arizona
- Cedars Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute · Los Angeles, California
- Cedars-Sinai Medical Center; SOCCI Pharmacy · Los Angeles, California
- UCSF Medical Center at Mission Bay · San Francisco, California
- Smilow Cancer Hospital at Yale - New Haven · New Haven, Connecticut
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04606446 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic anti-cancer therapy, cytotoxic chemotherapy disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 positive is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify