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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-004587-10 | EudraCT Number |
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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
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation (Part 1) | Experimental | Participants will receive PF-07209960 at escalating dose levels |
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| Dose Expansion (Part 2) - Cohort 1 (NSCLC) | Experimental | Participants with non-small cell lung cancer (NSCLC) will receive PF-07209960 at the recommended dose from Part 1 |
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| Dose Expansion (Part 2) - Cohort 2 (RCC) | Experimental | Participants with renal cell carcinoma (RCC) will receive PF-07209960 at the recommended dose from Part 1 |
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| Dose Expansion (Part 2) - Cohort 3 (UC) | Experimental | Participants with urothelial carcinoma (UC) will receive PF-07209960 at the recommended dose from Part 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07209960 | Biological | PD-1 targeted IL-15 mutein |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Investigational Drug Service (IDS) | Duarte | California | 91010 | United States | ||
| City of Hope |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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A total of 37 participants were enrolled and assigned to study treatment.
The study were 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-07209960 1 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months. |
| FG001 | PF-07209960 3 mg SC |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 30, 2020 | Feb 12, 2024 |
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| 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) |
| 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 | 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). | 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 | 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. | 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 | 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). | 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 | 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 | Baseline through up to 2 years or until disease progression |
| 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. | Baseline through up to 2 years or until disease progression |
| 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. | Baseline through up to 2 years or until disease progression |
| 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. | From start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 2 years approximately) |
| 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 |
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months. |
| FG002 | PF-07209960 10 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months. |
| FG003 | PF-07209960 15 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months. |
| FG004 | PF-07209960 20 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months. |
| FG005 | PF-07209960 30 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months. |
| COMPLETED |
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| NOT COMPLETED |
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Baseline analysis population included all participants who were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | PF-07209960 1 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months. |
| BG001 | PF-07209960 3 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months. |
| BG002 | PF-07209960 10 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months. |
| BG003 | PF-07209960 15 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months. |
| BG004 | PF-07209960 20 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months. |
| BG005 | PF-07209960 30 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
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| Primary | 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. | The DLT analysis set was a subset of the safety analysis set. A participant was classified as DLT-evaluable if he/she experienced a DLT or received 100% of the planned doses and had received all scheduled safety assessments during the DLT window. | Posted | Count of Participants | Participants | Cycle 1 (28 days) |
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| Primary | 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). | The safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months) |
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| Primary | 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. | The safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months) |
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| Primary | Number of Participants With TEAEs Leading to Death | TEAEs were those events with onset dates occurring during the on-treatment period. | The safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months) |
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| Primary | 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. | The safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months) |
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| Primary | 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). | The safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months) |
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| Primary | 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. | The safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months) |
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| Primary | 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. | The safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months) |
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| Primary | 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. | The safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months) |
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| Primary | 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. | The safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months) |
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| Secondary | 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. | Response evaluable set included all participants who received at least one dose of study treatment and had measurable disease at baseline and at least one post baseline disease assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | 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) |
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| Secondary | 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). | Immunogenicity analysis set includes all enrolled participants who receive at least one dose of study treatment and have at least one sample tested for ADA. Number of participants analyzed = Number of participants with >=1 post-treatment ADA result (N1). | Posted | Count of Participants | Participants | 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) |
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| Secondary | 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. | Immunogenicity analysis set includes all enrolled participants who receive at least one dose of study treatment and have at least one sample tested for ADA. Number of participants analyzed = Number of participants with >=1 post-treatment ADA result (N1). | Posted | Count of Participants | Participants | 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) |
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| Secondary | 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). | Immunogenicity analysis set includes all enrolled participants who receive at least one dose of study treatment and have at least one sample tested for ADA. Number of participants analyzed = Number of participants with >=1 post-treatment NAb result (N1). | Posted | Count of Participants | Participants | 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) |
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| Secondary | 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 | The full analysis set included all enrolled participants. | Posted | Median | 95% Confidence Interval | Months | Baseline through up to 2 years or until disease progression |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The full analysis set included all enrolled participants. | Posted | Median | 95% Confidence Interval | Months | Baseline through up to 2 years or until disease progression |
|
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The full analysis set includes all enrolled participants. | Posted | Median | 95% Confidence Interval | Months | Baseline through up to 2 years or until disease progression |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Response evaluable set included all participants who received at least one dose of study treatment and had measurable disease at baseline and at least one post baseline disease assessment. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 2 years approximately) |
|
AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-07209960 1 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months. | 1 | 4 | 3 | 4 | 4 | 4 |
| EG001 | PF-07209960 3 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months. | 1 | 4 | 3 | 4 | 2 | 4 |
| EG002 | PF-07209960 10 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months. | 1 | 4 | 1 | 4 | 3 | 4 |
| EG003 | PF-07209960 15 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months. | 1 | 3 | 1 | 3 | 3 | 3 |
| EG004 | PF-07209960 20 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months. | 3 | 16 | 13 | 16 | 16 | 16 |
| EG005 | PF-07209960 30 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months. | 1 | 6 | 5 | 6 | 5 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Bladder perforation | Renal and urinary disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Lip disorder | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Discomfort | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Early satiety | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Swelling face | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Herpes simplex reactivation | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Lymph gland infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pyuria | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
| |
| Stoma site reaction | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Interleukin level increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Non-systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Head discomfort | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Penile swelling | Reproductive system and breast disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Acute lung injury | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pharyngeal paraesthesia | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Rash morbilliform | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Scab | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Capillary leak syndrome | Vascular disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v26.0 | Non-systematic Assessment |
|
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 11, 2020 | Feb 12, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D002292 | Carcinoma, Renal Cell |
| D002295 | Carcinoma, Transitional Cell |
| D015179 | Colorectal Neoplasms |
| D010051 | Ovarian Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006258 | Head and Neck Neoplasms |
| D000230 | Adenocarcinoma |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D005833 | Genital Neoplasms, Female |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| 45-64 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Not reported |
|
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months. |
| OG003 | PF-07209960 15 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months. |
| OG004 | PF-07209960 20 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months. |
| OG005 | PF-07209960 30 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months. |
|
|
| OG002 | PF-07209960 10 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months. |
| OG003 | PF-07209960 15 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months. |
| OG004 | PF-07209960 20 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months. |
| OG005 | PF-07209960 30 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months. |
|
|
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months. |
| OG004 | PF-07209960 20 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months. |
| OG005 | PF-07209960 30 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months. |
|
|
| OG002 | PF-07209960 10 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months. |
| OG003 | PF-07209960 15 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months. |
| OG004 | PF-07209960 20 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months. |
| OG005 | PF-07209960 30 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months. |
|
|
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
| OG003 | PF-07209960 15 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months. |
| OG004 | PF-07209960 20 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months. |
| OG005 | PF-07209960 30 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months. |
|
|
| OG003 | PF-07209960 15 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months. |
| OG004 | PF-07209960 20 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months. |
| OG005 | PF-07209960 30 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months. |
|
|
| OG003 | PF-07209960 15 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months. |
| OG004 | PF-07209960 20 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months. |
| OG005 | PF-07209960 30 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months. |
|
|
| OG003 | PF-07209960 15 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months. |
| OG004 | PF-07209960 20 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months. |
| OG005 | PF-07209960 30 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months. |
|
|
| OG003 | PF-07209960 15 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months. |
| OG004 | PF-07209960 20 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months. |
| OG005 | PF-07209960 30 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months. |
|
|
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
| OG002 | PF-07209960 10 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months. |
| OG003 | PF-07209960 15 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months. |
| OG004 | PF-07209960 20 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months. |
| OG005 | PF-07209960 30 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months. |
|
|
| OG002 | PF-07209960 10 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months. |
| OG003 | PF-07209960 15 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months. |
| OG004 | PF-07209960 20 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months. |
| OG005 | PF-07209960 30 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months. |
|
|
| OG002 |
| PF-07209960 10 mg SC |
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months. |
| OG003 | PF-07209960 15 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months. |
| OG004 | PF-07209960 20 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months. |
| OG005 | PF-07209960 30 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months. |
|
|
| OG002 | PF-07209960 10 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months. |
| OG003 | PF-07209960 15 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months. |
| OG004 | PF-07209960 20 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months. |
| OG005 | PF-07209960 30 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months. |
|
|
| OG003 | PF-07209960 15 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months. |
| OG004 | PF-07209960 20 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months. |
| OG005 | PF-07209960 30 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months. |
|
|
|
| OG003 |
| PF-07209960 15 mg SC |
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months. |
| OG004 | PF-07209960 20 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months. |
| OG005 | PF-07209960 30 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months. |
|
|
| OG003 | PF-07209960 15 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months. |
| OG004 | PF-07209960 20 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months. |
| OG005 | PF-07209960 30 mg SC | Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months. |
|
|