Clinical trial NCT05067972: A Study of PF-07260437 in Advanced or Metastatic Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Ovarian Neoplasms
Endometrial Neoplasms
Breast Neoplasms
Keywords: Cancer of Endometrium
Cancer of the Endometrium
Carcinoma of Endometrium
Endometrial Cancer
Endometrial Carcinoma
Endometrium Cancer
Neoplasms, Endometrial
Cancer of Ovary
Cancer of the Ovary
Neoplasms, Ovarian
Ovarian Cancer
Ovary Cancer
Ovary Neoplasms
Breast Cancer
Breast Carcinoma
Breast Tumors
Cancer of Breast
Cancer of the Breast
Human Mammary Carcinoma
Malignant Neoplasm of Breast
Malignant Tumor of Breast
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-10-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Number of Participants With Dose-Limiting Toxicities (DLTs) in Dose Escalation - Part 1
timeFrame: The first dose of the study intervention (C1D1) through Day 28 for participants without a priming dose or through Day 42 for participants with a priming dose.
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) - Part 1
timeFrame: Baseline (Day 1 of dosing ) through 4 week follow-up, up to 35.1 weeks
measure: Number of Participants With Clinically Significant Laboratory Abnormalities - Part 1
timeFrame: Baseline through up to 35.1 weeks
Secondary outcomes:
measure: Number of Participants With Immune-Related Adverse Events (irAEs)
timeFrame: Day 1 up to 90 days after the last dose of study intervention (Day 246 [C9D15]), up to approximately 336 days
measure: Number of Participants by Categories of Anti-Drug Antibody (ADA) Against PF-07260437
timeFrame: On Day 1 of Cycle 1, 2, 3. From Cycle 4 onwards: collection on Day 1 of every 3 cycles (C4D1, C7D1, etc.) until end-of-treatment visit, up to 35.1 weeks.
measure: Single Dose: Maximal Concentration (Cmax)
timeFrame: Day 1 pre-dose, 1, 4, 8, 24, 48 and 168 hours post-dose, till Day 15 pre-dose in Cycle 1
measure: Single Dose: Area Under the Curve (AUCtau)
timeFrame: Day 1 pre-dose, 1, 4, 8, 24, 48 and 168 hours post-dose, till Day 15 pre-dose in Cycle 1
measure: Single Dose: Time to Maximal Plasma Concentration (Tmax)
timeFrame: Day 1 pre-dose, 1, 4, 8, 24, 48 and 168 hours post-dose, till Day 15 pre-dose in Cycle 1
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
state: California
city: Tampa
country: United States
facility: Moffitt Cancer Center at McKinley Campus
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: New Lenox
country: United States
facility: University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
state: Illinois
city: Orland Park
country: United States
facility: The University of Chicago Medicine Center of Advanced Care Orland Park
state: Illinois
city: Bronx
country: United States
facility: Montefiore Einstein Center for Cancer Care
state: New York
city: San Antonio
country: United States
facility: NEXT Oncology
state: Texas
city: Edmonds
country: United States
facility: Swedish Cancer Institute Edmonds Campus
state: Washington
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center - Mountlake
state: Washington
city: Rio Piedras
country: Puerto Rico
facility: Pan American Center for Oncology Trials, LLC
city: Rio Piedras
country: Puerto Rico
facility: Pan American Center for Oncology Trials- Hospital Oncologico
city: Rio Piedras
country: Puerto Rico
facility: Pan American Center for Oncology Trials
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: