Study Stopped
Pfizer has made an internal business decision to not continue further development of PF-07209960. This decision was not based on safety or regulatory considerations
Study to Test the Safety and Tolerability of PF-07209960 in Advanced or Metastatic Solid Tumors
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
2 other identifiers
interventional
37
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2020
Typical duration for phase_1
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2020
CompletedFirst Posted
Study publicly available on registry
November 16, 2020
CompletedStudy Start
First participant enrolled
December 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2023
CompletedResults Posted
Study results publicly available
July 29, 2024
CompletedJuly 29, 2024
February 1, 2024
2.4 years
November 9, 2020
February 12, 2024
February 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Number of Participants With Dose Limiting Toxicities (DLTs)
For the purpose of dose escalation, any of the following adverse events were classified as DLTs: Occur in the first cycle of treatment, or within 28 days after the start of the study treatment; and were at least possibly related to PF-07209960; A participant was classified as DLT evaluable if he/she experienced a DLT or if he/she otherwise in the absence of a DLT received 2 doses of the study intervention during Cycle 1 and had received all scheduled safety assessments during the DLT window. If a participant failed to meet these criteria, he/she might be replaced. Monitoring for DLTs occurred during Part 1.
Cycle 1 (28 days)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Adverse event (AE) was any untoward medical occurrence in a participant who received any study drug without regard to possibility of causal relationship. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 90 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. Treatment-related AEs were those related to any study drug (ie, at least one of the study drugs).
From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)
Number of Participants With Maximum Grade 3 or 4 TEAEs
AE was any untoward medical occurrence in a participant who received any study drug without regard to possibility of causal relationship. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 90 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. TEAEs were graded by the investigator using National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 5.0 as Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death. In this outcome measure, number of participants with Maximum Grade 3 or 4 TEAEs were reported.
From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)
Number of Participants With TEAEs Leading to Death
TEAEs were those events with onset dates occurring during the on-treatment period.
From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)
Number of Participants With Serious TEAEs
TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment until a minimum of 90 days after the last dose of study intervention. Treatment-related AEs were those related to any study drug (ie, at least one of the study drugs). A serious TEAE was any untoward medical occurrence that at any dose resulted in any of following outcomes/considered to be an important medical event: death; life-threatening experience (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect.
From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)
Number of Participants Discontinued From Study Due to TEAEs
Participants who had an AE record that indicated that the AE caused the participant to be discontinued from the study. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment until a minimum of 90 days after the last dose of study intervention. Treatment-related AEs were those related to any study drug (ie, at least one of the study drugs).
From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period
The number of participants with newly occurring or worsening hematology abnormalities during the on-treatment period were summarized by worst grade on-treatment. NCI-CTCAE criteria version 5.0 is used. As per NCI CTCAE toxicity grading v5.0, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death.
From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period
The number of participants with newly occurring or worsening hematology abnormalities during the on-treatment period were summarized by worst grade on-treatment. NCI-CTCAE criteria version 5.0 is used. As per NCI CTCAE toxicity grading v5.0, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death.
From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period
The number of participants with newly occurring or worsening chemistry abnormalities during the on-treatment period were summarized by worst grade on-treatment. NCI-CTCAE criteria version 5.0 is used. As per NCI CTCAE toxicity grading v5.0, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death.
From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period
The number of participants with newly occurring or worsening chemistry abnormalities during the on-treatment period were summarized by worst grade on-treatment. NCI-CTCAE criteria version 5.0 is used. As per NCI CTCAE toxicity grading v5.0, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death.
From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)
Secondary Outcomes (8)
Percentage of Participants With Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
From start of the treatment until disease progression or discontinuation from study or death due to any cause, whichever occurred first (maximum up to 14.5 months)
Number of Participants by Antidrug Antibody (ADA) Categories
on Day 1,15 and 22 of Cycle 1, on Day 1 of Cycles 2-9, and then on Day 1 of Cycles 12, 15, and at the end of treatment (EOT)
Number of Participants by ADA Against Endogenous IL-15 Wild-type Categories
on Day 1,15 and 22 of Cycle 1, on Day 1 of Cycles 2-9, and then on Day 1 of Cycles 12, 15, and at the end of treatment (EOT)
Number of Participants by Anti-IL-15 Wild Type NAb Categories
on Day 1,15 and 22 of Cycle 1, on Day 1 of Cycles 2-9, and then on Day 1 of Cycles 12, 15, and at the end of treatment (EOT)
Time to Progression (TTP) in Participants With Progressive Disease Based on Investigator Assessment
Baseline through up to 2 years or until disease progression
- +3 more secondary outcomes
Study Arms (4)
Dose Escalation (Part 1)
EXPERIMENTALParticipants will receive PF-07209960 at escalating dose levels
Dose Expansion (Part 2) - Cohort 1 (NSCLC)
EXPERIMENTALParticipants with non-small cell lung cancer (NSCLC) will receive PF-07209960 at the recommended dose from Part 1
Dose Expansion (Part 2) - Cohort 2 (RCC)
EXPERIMENTALParticipants with renal cell carcinoma (RCC) will receive PF-07209960 at the recommended dose from Part 1
Dose Expansion (Part 2) - Cohort 3 (UC)
EXPERIMENTALParticipants with urothelial carcinoma (UC) will receive PF-07209960 at the recommended dose from Part 1
Interventions
PD-1 targeted IL-15 mutein
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (13)
City of Hope Investigational Drug Service (IDS)
Duarte, California, 91010, United States
City of Hope
Duarte, California, 91010, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
UCLA Hematology/Oncology
Los Angeles, California, 90095, United States
Santa Monica UCLA Medical Center & Orthopaedic Hospital
Santa Monica, California, 90404, United States
UCLA Hematology Oncology - Santa Monica
Santa Monica, California, 90404, United States
Tennessee Oncology PLLC
Nashville, Tennessee, 37203, United States
The Sarah Cannon Research Institute/Tennessee Oncology
Nashville, Tennessee, 37203, United States
TriStar Centennial Medical Center
Nashville, Tennessee, 37203, United States
The University of Texas MD Anderson Cancer Center- Investigational Pharmacy
Houston, Texas, 77030, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Christus Santa Rosa Hospital
San Antonio, Texas, 78229, United States
NEXT Oncology
San Antonio, Texas, 78229, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was planned to have 2 parts: a single agent dose escalation (Part 1) followed by a dose expansion (Part 2). Due to the early termination of the study, Part 2 study was never initiated and the overall study consisted of only Part 1. The data displayed are from the Part 1 study which is the only 1 period of the study. Besides, the pharmacokinetic (PK) endpoints of this study were not conducted. Therefore no results of PK parameters are displayed.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2020
First Posted
November 16, 2020
Study Start
December 16, 2020
Primary Completion
May 3, 2023
Study Completion
May 26, 2023
Last Updated
July 29, 2024
Results First Posted
July 29, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share
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.