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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 : March 11, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 9, 2020
First Posted Date  ICMJE November 16, 2020
Last Update Posted Date March 11, 2021
Actual Study Start Date  ICMJE December 16, 2020
Estimated Primary Completion Date October 18, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2020)
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2020)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Disease control rate (DCR) [ Time Frame: Baseline through up to 2 years or until disease progression ]
    DCR as assessed using RECIST 1.1
  • Duration of response (DOR) [ Time Frame: Baseline through up to 2 years or until disease progression ]
    DOR as assessed using RECIST 1.1
  • Time to progression (TTP) [ Time Frame: Baseline through up to 2 years or until disease progression ]
    TTP as assessed using RECIST 1.1
  • Progression free survival (PFS) [ Time Frame: Baseline through up to 2 years or until disease progression ]
    PFS as assessed using RECIST 1.1
  • Overall survival (OS) in the Expansion Cohorts (Part 2) [ Time Frame: Baseline through up to 2 years ]
    Proportion of participants alive
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Test the Safety and Tolerability of PF-07209960 in Advanced or Metastatic Solid Tumors
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-small-cell Lung Cancer
  • Squamous Cell Carcinoma of the Head and Neck
  • Renal Cell Carcinoma
  • Urothelial Carcinoma
  • Colorectal Carcinoma
  • Ovarian Carcinoma
Intervention  ICMJE Biological: PF-07209960
PD-1 targeted IL-15 mutein
Study Arms  ICMJE
  • Experimental: Dose Escalation (Part 1)
    Participants will receive PF-07209960 at escalating dose levels
    Intervention: Biological: PF-07209960
  • 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
    Intervention: Biological: PF-07209960
  • 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
    Intervention: Biological: PF-07209960
  • Experimental: Dose Expansion (Part 2) - Cohort 3 (UC)
    Participants with urothelial carcinoma (UC) will receive PF-07209960 at the recommended dose from Part 1
    Intervention: Biological: PF-07209960
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 9, 2020)
172
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 22, 2025
Estimated Primary Completion Date October 18, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04628780
Other Study ID Numbers  ICMJE C4011001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP