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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05067972
Other study ID # C4431001
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date October 7, 2021
Est. completion date October 17, 2023

Study information

Verified date December 2023
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 30
Est. completion date October 17, 2023
Est. primary completion date October 17, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Drug:
PF-07260437
B7-H4 x CD3 bi-specific mAb
Diagnostic Test:
B7-H4 IHC
B7-H4 expression

Locations

Country Name City State
Puerto Rico Pan American Center for Oncology Trials Rio Piedras
Puerto Rico Pan American Center for Oncology Trials, LLC Rio Piedras
Puerto Rico Pan American Center for Oncology Trials- Hospital Oncologico Rio Piedras
United States Montefiore Einstein Center for Cancer Care Bronx New York
United States University of Chicago Medical Center Chicago Illinois
United States City of Hope (City of Hope National Medical Center, City of Hope Medical Center) Duarte California
United States Swedish Cancer Institute Edmonds Campus Edmonds Washington
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 NEXT Oncology San Antonio Texas
United States Fred Hutchinson Cancer Center Seattle Washington
United States Swedish Cancer Institute Seattle Washington
United States University of Washington Medical Center - Mountlake Seattle Washington
United States Moffitt Cancer Center Tampa Florida
United States Moffitt Cancer Center at McKinley Campus Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with dose limiting toxicities (DLTs) in Dose escalation DLTs will be evaluated in Part 1. The number of DLTs will be used to determine the dose escalation decision and recommended dose of PF-07260437 Baseline through 28 days after first dose
Primary Number of participants with adverse events Baseline through up to 2 years
Primary Number of participants with clinically significant laboratory abnormalities Baseline through 2 years
Primary Number of participants with clinical adverse events at the recommended dose for expansion Baseline through up to 2 years
Primary Number of participants with clinically significant laboratory abnormalities at recommended dose for expansion Baseline through 2 years
Secondary Number of participants with immune related adverse events Baseline through 90 days
Secondary Single dose: Maximal concentration (Cmax) PK assessment for PF-07260437 Cycle 1 (each cycle is 28 days), Cycle 2, Cycle 3, and Day 1 of each subsequent cycle through end of treatment, up to about 2 years
Secondary Time to maximal plasma concentration (Tmax) PK assessment of PF-07260437 Cycle 1 (each cycle is 28 days), Cycle 2, Cycle 3, and Day 1 of each subsequent cycle through end of treatment, up to about 2 years
Secondary Single dose: Area Under the Curve (AUClast) PK assessment of PF-07260437 Cycle 1 (each cycle is 28 days), Cycle 2, Cycle 3, and Day 1 of each subsequent cycle through end of treatment, up to about 2 years
Secondary Plasma Decay Half-live (t1/2) PK assessment of PF-07260437 Cycle 1 (each cycle is 28 days), Cycle 2, Cycle 3, and Day 1 of each subsequent cycle through end of treatment, up to about 2 years
Secondary Area Under the Curve from Time Zero to Extrapolated Infinite Time (AUCinf) PK assessment of PF-07260437 Cycle 1 (each cycle is 28 days), Cycle 2, Cycle 3, and Day 1 of each subsequent cycle through end of treatment, up to about 2 years
Secondary Apparent Volume of Distribution (Vz/F) PK assessment of PF-0260347 Cycle 1 (each cycle is 28 days) Cycle 2, Cycle 3, and Day 1 of each subsequent cycle through end of treatment, up to about 2 years
Secondary Accumulation Ratio (Rac) PK assessment for PF-07260437 Cycle 1 (each cycle is 28 days), Cycle 2, Cycle 3 and Day 1 of each subsequent cycle through end of treatment, up to about 2 years
Secondary Apparent Oral Clearance (CL/F) PF assessment of PF-07260437 Cycle 1 (each cycle is 28 days), Cycle 2, Cycle 3, and Day 1 of each subsequent cycle through end of treatment, up to about 2 years
Secondary Apparent Oral Clearance of Study Drug (CLss/F) PK assessment for PF-07260437 Cycle 1 (each cycle is 28 days), Cycle 2, Cycle 3, and Day of each subsequent cycle through end of treatment, up to about 2 years
Secondary Area under the curve at steady state under a dosing interval (AUCss,t) PK assessment of PF-07260437 Cycle 1 (each cycle is 28 days), Cycle 2, Cycle 3, and Day 1 of each subsequent cycle through end of treatment, up to about 2 years
Secondary Maximum Observed Plasma Concentration at Steady State (Cmax,ss) PK assessment of PF-07260437 Cycle 1 (each cycle is 28 days), Cycle 2, Cycle 3, and Day 1 of each subsequent cycle through end of treatment, up to about 2 years
Secondary Time to reach maximum Observed Plasma Concentration at Steady State (Tmax,ss) PK assessment of PF-07260437 Cycle 1 (each cycle is 28 days), Cycle 2, Cycle 3, and Day 1 of each subsequent Cycle through end of treatment, up to about 2 years
Secondary Minimum Observed Plasma Trough Concentration at Steady State (Cmin,ss) PK assessment for PF-07260437 Cycle 1 (each cycle is 28 days), Cycle 2, Cycle 3 and Day 1 of each subsequent cycle through end of treatment, up to about 2 years.
Secondary Incident and titers of anti-body drug antibody against PF-07260437 Immunogenicity of PF-07260437 Cycle 1 (each cycle is 28 days), Cycle 2, Cycle 3, and Day 1 of each subsequent cycle through end of treatment, up to about 2 years
Secondary Incident and titers of anti-body neutralizing antibody against PF-07260437 Immunogenicity of PF-07260437 Cycle 1 (each cycle is 28 days), Cycle 2, Cycle 3, and Day 1 of each subsequent cycle through end of treatment, up to about 2 years
Secondary Number of participants with immune related adverse events at the recommended dose for expansion Baseline through up to 2 years
Secondary Duration of response (DOR) in dose expansion DOR as assessed using RECIST 1.1 and irRECIST Baseline through up to 2 years or until disease progression
Secondary Time to progression (TTP) in dose expansion TTP as assessed using RECIST 1.1 and irRECIST Baseline through up to 2 years or until disease progression
Secondary Objective response rate (ORR) in dose expansion ORR as assessed using RECIST 1.1 and irRECIST Baseline through up to 2 years or until disease progression
Secondary Progression free survival (PFS) PFS as assessed using RECIST 1.1 and irRECIST Baseline through up to 2 years or until disease progression
Secondary Overall survival (OS) in the Expansion Cohorts (Part 2) Proportion of participants alive Baseline through up to 2 years
Secondary Phenotypes and quantity of tumor infiltrating lymphocytes (TIL) before and after PF-07260437 treatment Immune Cells assessments from paired biopsies 28 days prior to first dose and 7 days within Cycle 2, Day 15 of PF-07260437
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