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Non-small-cell Lung CancerPhase 1NCT04628780

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

A Phase 1 study testing PF-07209960 in people with Non-small-cell Lung Cancer and Squamous Cell Carcinoma of the Head and Neck, run by Pfizer at 13 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PF-07209960
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
13 sitesUnited States
Study dates
16 Dec 2020to 26 May 2023
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • City of Hope Investigational Drug Service (IDS)

    Duarte, California, 91010

  • City of Hope

    Duarte, California, 91010

  • The University of Texas MD Anderson Cancer Center- Investigational Pharmacy

    Houston, Texas, 77030

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

  • UCLA Hematology/Oncology

    Los Angeles, California, 90095

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37203

  • The Sarah Cannon Research Institute/Tennessee Oncology

    Nashville, Tennessee, 37203

  • TriStar Centennial Medical Center

    Nashville, Tennessee, 37203

  • Christus Santa Rosa Hospital

    San Antonio, Texas, 78229

  • NEXT Oncology

    San Antonio, Texas, 78229

  • Santa Monica UCLA Medical Center & Orthopaedic Hospital

    Santa Monica, California, 90404

  • UCLA Hematology Oncology - Santa Monica

    Santa Monica, California, 90404

Other trials in United States

About this study

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

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.

Being tested
PF-07209960
Keywords
PD-1, immune checkpoint inhibitor, IL-15, IL-2, cytokine, immunotherapy, Metastasis, advanced solid tumor, metastatic solid tumor
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Colorectal Neoplasms, Ovarian Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-07209960Biological

    PD-1 targeted IL-15 mutein

Study groups in NCT04628780
Study groupRoleWhat they receive
Dose Escalation (Part 1)ExperimentalParticipants will receive PF-07209960 at escalating dose levels
Receives: Biological: PF-07209960
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
Receives: Biological: PF-07209960
Dose Expansion (Part 2) - Cohort 2 (RCC)ExperimentalParticipants with renal cell carcinoma (RCC) will receive PF-07209960 at the recommended dose from Part 1
Receives: Biological: PF-07209960
Dose Expansion (Part 2) - Cohort 3 (UC)ExperimentalParticipants with urothelial carcinoma (UC) will receive PF-07209960 at the recommended dose from Part 1
Receives: Biological: PF-07209960

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Cycle 1 (28 days)

  2. 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).

    Measured: From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)

  3. 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.

    Measured: From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)

  4. Number of Participants With TEAEs Leading to Death

    TEAEs were those events with onset dates occurring during the on-treatment period.

    Measured: From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)

  5. 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.

    Measured: From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)

  6. 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).

    Measured: From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)

  7. 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.

    Measured: From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)

  8. 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.

    Measured: From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)

  9. 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.

    Measured: From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)

  10. 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.

    Measured: 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)

  1. Percentage of Participants With Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

    Objective Response Rate (ORR) is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per RECIST version 1.1. CR: Complete disappearance of all target and non-target lesions with the exception of nodal disease; all target and non-target nodes must decrease to normal size (short axis <10 mm); all lesions must be assessed. PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions; all target lesions must be assessed. Non-target PR lesions must be non-progressive disease (PD), where PD is unequivocal progression of pre-existing lesions.

    Measured: 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)

  2. Number of Participants by Antidrug Antibody (ADA) Categories

    Immunogenicity blood samples were assayed for ADA using a validated assay. The sample analysis followed a tiered approach of screening, confirmation, and titer determination. Samples tested positive for ADA were further analyzed for neutralizing antibodies (Nab) using a validated assay. Baseline is defined as pre-dose measurement on Day 1. n=Number of ADA evaluable participants with positive ADA at baseline; n1=Number of ADA evaluable participants with positive ADA at baseline but did not become boosted post-treatment; n2=Number of ADA-positive participants (treatment-induced or treatment-boosted).

    Measured: 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)

  3. Number of Participants by ADA Against Endogenous IL-15 Wild-type Categories

    Immunogenicity blood samples were assayed for ADA using a validated assay. The sample analysis followed a tiered approach of screening, confirmation, and titer determination. Samples tested positive for ADA were further analyzed for neutralizing antibodies (Nab) using a validated assay. Baseline is defined as pre-dose measurement on Day 1. n=Number of ADA evaluable participants with positive ADA at baseline; n2=Number of ADA-positive participants.

    Measured: 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)

  4. Number of Participants by Anti-IL-15 Wild Type NAb Categories

    Immunogenicity blood samples were assayed for ADA using a validated assay. The sample analysis followed a tiered approach of screening, confirmation, and titer determination. Samples tested positive for ADA were further analyzed for neutralizing antibodies (NAb) using a validated assay. Baseline is defined as pre-dose measurement on Day 1. N1=Number of participants with ≥ 1 post-treatment NAb result; n=Number of NAb evaluable participants with positive NAb at baseline; n2=Number of NAb-positive participants (treatment induced).

    Measured: 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)

  5. Time to Progression (TTP) in Participants With Progressive Disease Based on Investigator Assessment

    TTP is defined as the time from start date of treatment to the date of the first documentation of PD or censoring. TTP is similar to PFS except that death is not treated as an event and is censored. Both new anti-cancer therapy given prior to PD and no PD by the end of follow-up are censoring events

    Measured: Baseline through up to 2 years or until disease progression

  6. Duration of Response (DOR) Based on Investigator Assessment in Participants With Confirmed Response

    DOR is defined as the time from first documentation of CR or PR to date of first documentation of objective progression, or death due to any cause, or time of censoring, whichever occurred first.

    Measured: Baseline through up to 2 years or until disease progression

  7. Progression-Free Survival (PFS) Based on Investigator Assessment in Participants

    PFS is defined as time from start date of treatment to the date of first documentation of PD or death due to any cause, or censoring, whichever occurred first. Both new anti-cancer therapy given prior to PD or death and no PD by the end of follow-up are censoring events.

    Measured: Baseline through up to 2 years or until disease progression

  8. Percentage of Participants With Disease Control Based on Investigator Assessment

    Disease control rate (DCR) is defined as the percentage of participants with a BOR of CR, PR, non-CR/non-PD or SD.

    Measured: From start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 2 years approximately)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2020
  2. Study start16 Dec 2020
  3. Primary completion3 May 2023
  4. Study completion26 May 2023

Why it 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

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04628780
Sponsor's protocol ID
C4011001
Other IDs
2021-004587-10
Status last verified
Feb 2024
First submitted
9 Nov 2020
Last updated
29 Jul 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-07209960 in people with Non-small-cell Lung Cancer and Squamous Cell Carcinoma of the Head and Neck, run by Pfizer at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Dose Limiting Toxicities (DLTs) (time frame: Cycle 1 (28 days)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04628780.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.

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