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

Stopped early · Phase 1

Conditions studied: Ovarian Neoplasms, Endometrial Neoplasms, Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT05067972

Run by

Pfizer

People needed

30

Starts

2021-10-07

Expected to finish

2023-10-17

Last updated by the study team

2025-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• City of Hope (City of Hope National Medical Center, City of Hope Medical Center) — Duarte, California, United States
• Moffitt Cancer Center at McKinley Campus — Tampa, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• University of Chicago Comprehensive Cancer Center at Silver Cross Hospital — New Lenox, Illinois, United States
• The University of Chicago Medicine Center of Advanced Care Orland Park — Orland Park, Illinois, United States
• Montefiore Einstein Center for Cancer Care — The Bronx, New York, United States
• NEXT Oncology — San Antonio, Texas, United States
• Swedish Cancer Institute Edmonds Campus — Edmonds, Washington, United States
• Swedish Cancer Institute — Seattle, Washington, United States
• Fred Hutchinson Cancer Center — Seattle, Washington, United States
• University of Washington Medical Center - Mountlake — Seattle, Washington, United States
• Pan American Center for Oncology Trials, LLC — Rio Piedras, Puerto Rico
• Pan American Center for Oncology Trials- Hospital Oncologico — Rio Piedras, Puerto Rico
• Pan American Center for Oncology Trials — Rio Piedras, Puerto Rico

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.