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A Study of PF-07260437 in Advanced or Metastatic Solid Tumors | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC, AND ANTITUMOR ACTIVITY OF PF-07260437 IN ADVANCED OR METASTATIC SOLID TUMORS

NCT05067972•Pfizer

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (15)

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

Key Dates

Start Date

October 7, 2021

Primary Completion Date

October 17, 2023

Completion Date

October 17, 2023

Last Updated

May 6, 2025

Enrollment

ACTUAL participants

Conditions

Ovarian NeoplasmsEndometrial NeoplasmsBreast Neoplasms

Interventions

PF-07260437

DRUG

B7-H4 IHC

DIAGNOSTIC_TEST

A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer

NCT07213804

Ovarian NeoplasmsFallopian Tube Neoplasms+2 more

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RECRUITING

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

NCT07191730

CardiotoxicityHeart Failure+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)

Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)

Evaluation of Clinical Efficacy of Augmented Reality (AR)-Based Breast Cancer Medical Imaging Solution (SKIA-Breast) Localization Method in Breast Cancer Patients

A Study of LY4175408 in Participants With Advanced Cancer