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NCT04628780 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1
Status at capture
TERMINATED
Registry last update
2024-07-29

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Dose Limiting Toxicities (DLTs)

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outcome · POSTED

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

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outcome · POSTED

Number of Participants With Maximum Grade 3 or 4 TEAEs

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outcome · POSTED

Number of Participants With TEAEs Leading to Death

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outcome · POSTED

Number of Participants With Serious TEAEs

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outcome · POSTED

Number of Participants Discontinued From Study Due to TEAEs

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outcome · POSTED

Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period

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outcome · POSTED

Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period

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outcome · POSTED

Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period

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outcome · POSTED

Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period

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outcome · POSTED

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

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outcome · POSTED

Number of Participants by Antidrug Antibody (ADA) Categories

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

Percentage of Participants With Disease Control Based on Investigator Assessment

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants will receive PF-07209960 at escalating dose levels
    intervention Names
    1. Biological: PF-07209960
    label
    Dose Escalation (Part 1)
    type
    EXPERIMENTAL
  2. description
    Participants with non-small cell lung cancer (NSCLC) will receive PF-07209960 at the recommended dose from Part 1
    intervention Names
    1. Biological: PF-07209960
    label
    Dose Expansion (Part 2) - Cohort 1 (NSCLC)
    type
    EXPERIMENTAL
  3. description
    Participants with renal cell carcinoma (RCC) will receive PF-07209960 at the recommended dose from Part 1
    intervention Names
    1. Biological: PF-07209960
    label
    Dose Expansion (Part 2) - Cohort 2 (RCC)
    type
    EXPERIMENTAL
  4. description
    Participants with urothelial carcinoma (UC) will receive PF-07209960 at the recommended dose from Part 1
    intervention Names
    1. Biological: PF-07209960
    label
    Dose Expansion (Part 2) - Cohort 3 (UC)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Dose Escalation (Part 1)
    2. Dose Expansion (Part 2) - Cohort 1 (NSCLC)
    3. Dose Expansion (Part 2) - Cohort 2 (RCC)
    4. Dose Expansion (Part 2) - Cohort 3 (UC)
    description
    PD-1 targeted IL-15 mutein
    name
    PF-07209960
    type
    BIOLOGICAL
Study design
allocation
NON_RANDOMIZED
intervention Model
SEQUENTIAL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
37
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Number of Participants With Dose Limiting Toxicities (DLTs)
    time Frame
    Cycle 1 (28 days)
  2. description
    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).
    measure
    Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
    time Frame
    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. description
    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.
    measure
    Number of Participants With Maximum Grade 3 or 4 TEAEs
    time Frame
    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. description
    TEAEs were those events with onset dates occurring during the on-treatment period.
    measure
    Number of Participants With TEAEs Leading to Death
    time Frame
    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. description
    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.
    measure
    Number of Participants With Serious TEAEs
    time Frame
    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. description
    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).
    measure
    Number of Participants Discontinued From Study Due to TEAEs
    time Frame
    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. description
    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.
    measure
    Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period
    time Frame
    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. description
    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.
    measure
    Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period
    time Frame
    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. description
    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.
    measure
    Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period
    time Frame
    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. description
    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.
    measure
    Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period
    time Frame
    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
  1. description
    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.
    measure
    Percentage of Participants With Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
    time Frame
    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. description
    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).
    measure
    Number of Participants by Antidrug Antibody (ADA) Categories
    time Frame
    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. description
    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.
    measure
    Number of Participants by ADA Against Endogenous IL-15 Wild-type Categories
    time Frame
    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. description
    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).
    measure
    Number of Participants by Anti-IL-15 Wild Type NAb Categories
    time Frame
    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. description
    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
    measure
    Time to Progression (TTP) in Participants With Progressive Disease Based on Investigator Assessment
    time Frame
    Baseline through up to 2 years or until disease progression
  6. description
    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.
    measure
    Duration of Response (DOR) Based on Investigator Assessment in Participants With Confirmed Response
    time Frame
    Baseline through up to 2 years or until disease progression
  7. description
    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.
    measure
    Progression-Free Survival (PFS) Based on Investigator Assessment in Participants
    time Frame
    Baseline through up to 2 years or until disease progression
  8. description
    Disease control rate (DCR) is defined as the percentage of participants with a BOR of CR, PR, non-CR/non-PD or SD.
    measure
    Percentage of Participants With Disease Control Based on Investigator Assessment
    time Frame
    From start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 2 years approximately)
Full study description
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.
Source references
see Also Links
  1. label
    To obtain contact information for a study center near you, click here.
Source notices and limitations
    Discovery and provenance
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      query disease state id
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    Preserved source evidence · Not medical advice