Overview

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

Status:
Recruiting
Trial end date:
2025-02-22
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
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.