Breast Cancer Clinical Trial

A Study of PF-07260437 in Advanced or Metastatic Solid Tumors

Summary

A study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of PF-07260437, a B7-H4 x CD3 bispecific mAb, in participants aged ≥18 years of age with advanced or metastatic breast cancer, ovarian cancer or endometrial cancer. Adult participants with other advanced or metastatic high B7-H4 expressing tumors may be considered after discussion with and approval from sponsor.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Part 1: Histological/cytological diagnosis of selected locally advanced or metastatic breast cancer, endometrial cancer and ovarian cancer
Part 2A:In second line or more, participants with histological/cytological diagnosis of locally advanced or metastatic HR+ HER2- breast cancer showing high B7-H4 expression
Part 2B: In second line or more participants with histological or cytological diagnosis of locally advance or metastatic HR+ Her2- breast cancer or triple negative breast cancer (TNBC) with no biomarker pre-selection
Part 2C: In second line or more participants with histological diagnosis of locally advance or metastatic triple negative breast cancer with high B7-H4 expression
Thyroid function within normal laboratory range; in participants with abnormal thyroid function if Free T4 is normal and participant is clinically euthyroid, participants is eligible

Exclusion Criteria:

Participants with any active malignancy within 3 years prior to enrollment
Participants with advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including participants with massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement).
History of Grade ≥3 immune mediated adverse events (including liver function tests that where considered drug related and cytokine release syndrome) that was considered related to prior immune modulatory therapy (eg, immune checkpoint inhibitors, co stimulatory agents, etc.) and required immunosuppressive therapy within 1 year of treatment.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

100

Study ID:

NCT05067972

Recruitment Status:

Recruiting

Sponsor:

Pfizer

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There are 12 Locations for this study

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City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte California, 91010, United States
Moffitt Cancer Center at McKinley Campus
Tampa Florida, 33612, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
University of Chicago Medical Center
Chicago Illinois, 60637, United States
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
New Lenox Illinois, 60451, United States
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
New Lenox Illinois, 60451, United States
The University of Chicago Medicine Center of Advanced Care Orland Park
Orland Park Illinois, 60462, United States
Montefiore Einstein Center for Cancer Care
Bronx New York, 10461, United States
NEXT Oncology
San Antonio Texas, 78229, United States
Swedish Cancer Institute Edmonds Campus
Edmonds Washington, 98026, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States
Fred Hutchinson Cancer Center
Seattle Washington, 98109, United States
University of Washington Medical Center - Mountlake
Seattle Washington, 98195, United States
Pan American Center for Oncology Trials
Rio Piedras , 00935, Puerto Rico

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

100

Study ID:

NCT05067972

Recruitment Status:

Recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

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