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A Study of PF-07260437 in Advanced or Metastatic Solid Tumors (C4431001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05067972
Recruitment Status : Recruiting
First Posted : October 5, 2021
Last Update Posted : June 1, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ovarian Neoplasms Endometrial Neoplasms Breast Neoplasms Drug: PF-07260437 Diagnostic Test: B7-H4 IHC Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 7, 2021
Estimated Primary Completion Date : September 25, 2025
Estimated Study Completion Date : September 25, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Monotherapy dose escalation (Part 1)
Participants will receive PF-07260437
 Drug: PF-07260437
B7-H4 x CD3 bi-specific mAb
Other Name: B7-H4
Experimental: Dose Expansion (Part 2A) - Tumor specific Arm A
Participants will receive PF-07260437
 Drug: PF-07260437
B7-H4 x CD3 bi-specific mAb
Other Name: B7-H4

Diagnostic Test: B7-H4 IHC
B7-H4 expression
Experimental: Dose Expansion (Part 2B) - Tumor specific Arm B
Participants will receive PF-07260437
 Drug: PF-07260437
B7-H4 x CD3 bi-specific mAb
Other Name: B7-H4

Diagnostic Test: B7-H4 IHC
B7-H4 expression
Experimental: Dose Expansion (Part 2C) - Tumor specific Arm C
Participants will receive PF07260437
 Drug: PF-07260437
B7-H4 x CD3 bi-specific mAb
Other Name: B7-H4

Diagnostic Test: B7-H4 IHC
B7-H4 expression


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with dose limiting toxicities (DLTs) in Dose escalation [ Time Frame: Baseline through 28 days after first dose ]
    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

  2. Number of participants with adverse events [ Time Frame: Baseline through up to 2 years ]
  3. Number of participants with clinically significant laboratory abnormalities [ Time Frame: Baseline through 2 years ]
  4. Number of participants with clinical adverse events at the recommended dose for expansion [ Time Frame: Baseline through up to 2 years ]
  5. Number of participants with clinically significant laboratory abnormalities at recommended dose for expansion [ Time Frame: Baseline through 2 years ]

Secondary Outcome Measures :
  1. Number of participants with immune related adverse events [ Time Frame: Baseline through 90 days ]
  2. Single dose: Maximal concentration (Cmax) [ Time Frame: 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 ]
    PK assessment for PF-07260437

  3. Time to maximal plasma concentration (Tmax) [ Time Frame: 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 ]
    PK assessment of PF-07260437

  4. Single dose: Area Under the Curve (AUClast) [ Time Frame: 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 ]
    PK assessment of PF-07260437

  5. Plasma Decay Half-live (t1/2) [ Time Frame: 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 ]
    PK assessment of PF-07260437

  6. Area Under the Curve from Time Zero to Extrapolated Infinite Time (AUCinf) [ Time Frame: 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 ]
    PK assessment of PF-07260437

  7. Apparent Volume of Distribution (Vz/F) [ Time Frame: 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 ]
    PK assessment of PF-0260347

  8. Accumulation Ratio (Rac) [ Time Frame: 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 ]
    PK assessment for PF-07260437

  9. Apparent Oral Clearance (CL/F) [ Time Frame: 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 ]
    PF assessment of PF-07260437

  10. Apparent Oral Clearance of Study Drug (CLss/F) [ Time Frame: 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 ]
    PK assessment for PF-07260437

  11. Area under the curve at steady state under a dosing interval (AUCss,τ) [ Time Frame: 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 ]
    PK assessment of PF-07260437

  12. Maximum Observed Plasma Concentration at Steady State (Cmax,ss) [ Time Frame: 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 ]
    PK assessment of PF-07260437

  13. Time to reach maximum Observed Plasma Concentration at Steady State (Tmax,ss) [ Time Frame: 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 ]
    PK assessment of PF-07260437

  14. Minimum Observed Plasma Trough Concentration at Steady State (Cmin,ss) [ Time Frame: 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. ]
    PK assessment for PF-07260437

  15. Incident and titers of anti-body drug antibody against PF-07260437 [ Time Frame: 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 ]
    Immunogenicity of PF-07260437

  16. Incident and titers of anti-body neutralizing antibody against PF-07260437 [ Time Frame: 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 ]
    Immunogenicity of PF-07260437

  17. Number of participants with immune related adverse events at the recommended dose for expansion [ Time Frame: Baseline through up to 2 years ]
  18. Duration of response (DOR) in dose expansion [ Time Frame: Baseline through up to 2 years or until disease progression ]
    DOR as assessed using RECIST 1.1 and irRECIST

  19. Time to progression (TTP) in dose expansion [ Time Frame: Baseline through up to 2 years or until disease progression ]
    TTP as assessed using RECIST 1.1 and irRECIST

  20. Objective response rate (ORR) in dose expansion [ Time Frame: Baseline through up to 2 years or until disease progression ]
    ORR as assessed using RECIST 1.1 and irRECIST

  21. Progression free survival (PFS) [ Time Frame: Baseline through up to 2 years or until disease progression ]
    PFS as assessed using RECIST 1.1 and irRECIST

  22. Overall survival (OS) in the Expansion Cohorts (Part 2) [ Time Frame: Baseline through up to 2 years ]
    Proportion of participants alive

  23. Phenotypes and quantity of tumor infiltrating lymphocytes (TIL) before and after PF-07260437 treatment [ Time Frame: 28 days prior to first dose and 7 days within Cycle 2, Day 15 of PF-07260437 ]
    Immune Cells assessments from paired biopsies


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05067972


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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United States, California
City of Hope (City of Hope National Medical Center, City of Hope Medical Center) Recruiting
Duarte, California, United States, 91010
United States, Florida
Moffitt Cancer Center at McKinley Campus Recruiting
Tampa, Florida, United States, 33612
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital Recruiting
New Lenox, Illinois, United States, 60451
The University of Chicago Medicine Center of Advanced Care Orland Park Recruiting
Orland Park, Illinois, United States, 60462
United States, New York
Montefiore Einstein Center for Cancer Care Recruiting
Bronx, New York, United States, 10461
United States, Texas
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
United States, Washington
Swedish Cancer Institute Edmonds Campus Recruiting
Edmonds, Washington, United States, 98026
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Fred Hutchinson Cancer Center Recruiting
Seattle, Washington, United States, 98109
University of Washington Medical Center - Mountlake Recruiting
Seattle, Washington, United States, 98195
Puerto Rico
Pan American Center for Oncology Trials Recruiting
Rio Piedras, Puerto Rico, 00935
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05067972    
Other Study ID Numbers: C4431001
First Posted: October 5, 2021    Key Record Dates
Last Update Posted: June 1, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
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
Additional relevant MeSH terms:
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Neoplasms
Breast Neoplasms
Ovarian Neoplasms
Endometrial Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
 Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Uterine Neoplasms
Uterine Diseases