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Study to Test the Safety and Tolerability of PF-07209960 in Advanced or Metastatic Solid Tumors

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ClinicalTrials.gov Identifier: NCT04628780
Recruitment Status : Recruiting
First Posted : November 16, 2020
Last Update Posted : September 21, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:

This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and dose expansion study intended to evaluate the safety, pharmacokinetic, pharmacodynamic, and potential clinical benefit of PF-07209960, an anti-PD-1 targeting IL-15 fusion protein, in participants with selected locally advanced or metastatic solid tumors for whom no standard therapy is available, or would not be an appropriate option in the opinion of the participant and their treating physician, or participants who have refused standard therapy.

The study contains 2 parts, single agent Dose Escalation (Part 1) to determine the recommended dose of PF-07209960, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose.


Condition or disease Intervention/treatment Phase
Non-small-cell Lung Cancer Squamous Cell Carcinoma of the Head and Neck Renal Cell Carcinoma Urothelial Carcinoma Colorectal Carcinoma Ovarian Carcinoma Biological: PF-07209960 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC, AND ANTI-TUMOR ACTIVITY OF PF-07209960 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS
Actual Study Start Date : December 16, 2020
Estimated Primary Completion Date : October 18, 2023
Estimated Study Completion Date : March 22, 2025


Arm Intervention/treatment
Experimental: Dose Escalation (Part 1)
Participants will receive PF-07209960 at escalating dose levels
Biological: PF-07209960
PD-1 targeted IL-15 mutein

Experimental: Dose Expansion (Part 2) - Cohort 1 (NSCLC)
Participants with non-small cell lung cancer (NSCLC) will receive PF-07209960 at the recommended dose from Part 1
Biological: PF-07209960
PD-1 targeted IL-15 mutein

Experimental: Dose Expansion (Part 2) - Cohort 2 (RCC)
Participants with renal cell carcinoma (RCC) will receive PF-07209960 at the recommended dose from Part 1
Biological: PF-07209960
PD-1 targeted IL-15 mutein

Experimental: Dose Expansion (Part 2) - Cohort 3 (UC)
Participants with urothelial carcinoma (UC) will receive PF-07209960 at the recommended dose from Part 1
Biological: PF-07209960
PD-1 targeted IL-15 mutein




Primary Outcome Measures :
  1. Number of participants with dose limiting toxicities (DLTs) in Dose Escalation (Part 1) [ Time Frame: Baseline through 28 days after first dose (Cycle 1) ]
    DLTs will be evaluated during Cycle 1 (a cycle is 28 days) in Part 1. The number of DLTs will be used to determine the optimal dose

  2. Number of participants with adverse events (AEs) [ Time Frame: Baseline through up to 2 years ]
    AEs as characterized by type, frequency, severity (graded by CTCAE v.5.0; CRS graded by ASTCT criteria), timing, seriousness, and relationship to study drug

  3. Number of participants with clinically significant laboratory abnormalities [ Time Frame: Baseline through up to 2 years ]
    Laboratory abnormalities as characterized by type, frequency, severity (graded by CTCAE v.5.0), and timing

  4. Objective response rate (ORR) in the Expansion cohorts (Part 2) [ Time Frame: Baseline through up to 2 years or until disease progression ]
    Tumor response based on RECIST 1.1


Secondary Outcome Measures :
  1. ORR in Dose Escalation (Part 1) [ Time Frame: Baseline through up to 2 years or until disease progression ]
    Tumor response based on RECIST 1.1

  2. Single dose: Maximal concentration (Cmax) [ Time Frame: Cycle 1 (each cycle is 28 days), Cycle 2, and Day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 years ]
    PK assessment for PF-07209960

  3. Single dose: Time to maximal plasma concentration (Tmax) [ Time Frame: Cycle 1 (each cycle is 28 days), Cycle 2, and Day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 years ]
    PK assessment for PF-07209960

  4. Single dose: Area Under the Curve within one dosing interval (AUCtau) [ Time Frame: Cycle 1 (each cycle is 28 days), Cycle 2, and Day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 years ]
    PK assessment for PF-07209960

  5. Multiple dose: Maximum observed steady state plasma concentration (Cmax,ss) [ Time Frame: Cycle 1 (each cycle is 28 days), Cycle 2, and Day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 years ]
    PK assessment for PF-07209960

  6. Multiple dose: Time to reach Maximum Observed Steady State Plasma Concentration (Tmax,ss) [ Time Frame: Cycle 1 (each cycle is 28 days), Cycle 2, and Day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 years ]
    PK assessment for PF-07209960

  7. Multiple dose: Area Under the curve within one dose interval at steady state (AUCtau,ss) [ Time Frame: Cycle 1 (each cycle is 28 days), Cycle 2, and Day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 years ]
    PK assessment for PF-07209960

  8. Lowest concentration (Ctrough) reached before the next dose is administered [ Time Frame: Cycle 1 (each cycle is 28 days), Cycle 2, and day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 years ]
    PK assessment for PF-07209960

  9. Immunogenicity in Expansion Cohorts (Part 2) [ Time Frame: Cycle 1 (each cycle is 28 days), Cycle 2, and Day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 years ]
    Incidence, titers, and endogenous IL-15 cross-reactivity of anti-drug antibody and neutralizing antibody against PF-07209960

  10. Intratumor T cells in pre-treatment vs. on-treatment tumor biopsy samples in Expansion Cohorts (Part 2) [ Time Frame: Baseline through start of Cycle 2 ]
    Effect of PF-07209960 therapy on immune cells in tumor biopsies

  11. Disease control rate (DCR) [ Time Frame: Baseline through up to 2 years or until disease progression ]
    DCR as assessed using RECIST 1.1

  12. Duration of response (DOR) [ Time Frame: Baseline through up to 2 years or until disease progression ]
    DOR as assessed using RECIST 1.1

  13. Time to progression (TTP) [ Time Frame: Baseline through up to 2 years or until disease progression ]
    TTP as assessed using RECIST 1.1

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

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



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:

  • Histological/cytological diagnosis of selected locally advanced or metastatic solid tumor
  • Demonstrated radiographic progression on most recent tumor assessment imaging
  • Have ≥1 measurable lesion as defined by RECIST 1.1 that has not been previously irradiated
  • Eastern Cooperative Oncology Group performance status 0-2 for Part 1 and 0-1 for Part 2
  • Adequate hematologic, renal, liver, and coagulation functions
  • LVEF ≥50% by echocardiogram or MUGA
  • Resolved acute effects of any prior therapy
  • Participants in Dose Expansion (Part 2) must have ≥2 prior lines of standard of care therapy
  • Able to provide tumor tissue for submission to the Sponsor, including mandatory pre-treatment tumor biopsy (adequate archival tissue within the past 1 year is accepted in lieu of new biopsy) for all participants. Participants in Part 2 must also be able to undergo new (de novo) tumor biopsy at baseline (pre-treatment) and on-treatment biopsy until the Sponsor deems that an adequate number of biopsied samples have been received.

Exclusion Criteria:

  • Known active symptomatic brain or leptomeningeal metastases requiring steroids.
  • Other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
  • Major surgery or radiation therapy within 4 weeks prior to planned first dose
  • Last systemic anti-cancer therapy within 4 weeks prior to planned first dose (6 weeks for mitomycin C or nitrosoureas). Participants who received anti-PD-1 therapy require an interval of 90 days prior to first dose
  • Participation in other studies involving investigational drug(s) within 4 weeks prior to planned first dose
  • Active and clinically significant bacterial, fungal, or viral infection; Hepatitis B or Hepatitis C infection, AIDS-related illness (HIV+ and in good immune health as defined in the protocol may be eligible)
  • Active COVID-19/SARS-CoV2
  • Anticoagulation with vitamin K antagonists is not allowed
  • Active bleeding disorder in the past 6 months prior to first dose
  • History of clinically significant severe immune mediated adverse event that was considered related to prior immune modulatory therapy and required immunosuppressive therapy (other than hormone replacement therapy)
  • History of interstitial lung disease or pneumonitis
  • Organ transplant requiring immunosuppressive treatment or prior allogeneic bone marrow or hematopoietic stem cell transplant
  • Pregnant or breastfeeding female participant

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): NCT04628780


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 Investigational Drug Service (IDS) Recruiting
Duarte, California, United States, 91010
City of Hope Recruiting
Duarte, California, United States, 91010
Ronald Reagan UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
UCLA Hematology/Oncology Recruiting
Los Angeles, California, United States, 90095
Santa Monica UCLA Medical Center & Orthopaedic Hospital Recruiting
Santa Monica, California, United States, 90404
UCLA Hematology Oncology - Santa Monica Recruiting
Santa Monica, California, United States, 90404
United States, Tennessee
The Sarah Cannon Research Institute/Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
TriStar Centennial Medical Center Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
The University of Texas MD Anderson Cancer Center- Investigational Pharmacy Recruiting
Houston, Texas, United States, 77030
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Christus Santa Rosa Hospital Recruiting
San Antonio, Texas, United States, 78229
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
United States, Washington
Seattle Cancer Care Alliance Not yet recruiting
Seattle, Washington, United States, 98109
University of Washington Medical Center Not yet recruiting
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04628780    
Other Study ID Numbers: C4011001
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 2021
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:
PD-1
immune checkpoint inhibitor
IL-15
IL-2
cytokine
immunotherapy
Metastasis
advanced solid tumor
metastatic solid tumor
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Squamous Cell Carcinoma of Head and Neck
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Carcinoma, Squamous Cell
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Head and Neck Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases