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This is a Phase 1b/2 protocol to evaluate pharmacokinetics, safety, efficacy, and pharmacodynamics of PF-06801591, a programmed death-1(PD-1) antagonist monoclonal antibody (mAb) in participants with advanced malignancies.
This study consists of 2 parts:
Phase 1b part (dose escalation and dose expansion) in patients with advanced malignancies in Asia and a global Phase 2 part in non small cell lung cancer (NSCLC) patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A1 (Phase 1b) | Experimental |
| |
| Arm B1 (Phase 1b) | Experimental |
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| Arm A2 (Phase 2) | Experimental |
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| Arm B2 (Phase 2) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06801591 | Drug | A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PDL1/ PD-L2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLT) | This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with first line (1L) and second line (2L) non-small cell lung cancer (NSCLC) (Phase 2). For the Phase 1b, any of the following AEs occurring during the DLT observation period (the first cycle of treatment) which were attributable to the investigational product were classified as DLTs: Grade 5 AE not clearly due to the underlying disease or extraneous causes; Hematologic toxicity; Non-Hematologic Toxicity; Delay of ≥ 3 weeks in receiving the next scheduled administration due to persisting treatment-related toxicities. | Phase 1b: at the end of cycle 1 (28 days) for the PF-06801591 300 mg SC Q4W arms, and (42 days) for the PF-06801591 600 mg SC Q6W arms |
| Phase 2: AUCÏ„ of PF-06801591 at Steady State | This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). AUCÏ„ is area under the plasma concentration-time profile from time zero to the next dose (at steady state, starting at Week 12). (Ï„ = X days, where X = 28 days for Q4W regimen and 42 days for Q6W regimen) | Phase 2: Cycle 4 Day 1, 8, 15, 22 and Cycle 5 Day 1 for the PF-06801591 300 mg SC Q4W arm, and Cycle 3 Day 1, 8, 15, 29 and Cycle 4 Day 1 for the PF-06801591 600 mg SC Q6W arm |
| Phase 2: Ctrough of PF-06801591 at Steady State, at Week 12 | This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). Steady state Ctrough is pre-dose concentration following multiple dosing at steady state (Week 12) | Phase 2: Cycle 4 Day 1 for the PF-06801591 300 mg SC Q4W arm, and Cycle 3 Day 1 for the PF-06801591 600 mg SC Q6W arm |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events | This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Phase 1b/2: On-treatment period is defined as the time from the first dose of study treatment through minimum (30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day). |
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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 |
|---|---|---|---|---|---|---|
| Beijing Cancer hospital | Beijing | Beijing Municipality | 100142 | China | ||
| Chongqing Cancer Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39281971 | Derived | Penkov K, Bondarenko I, Saenko DV, Kulyaba Y, Guo J, Gong Y, Yamamoto N, Hotko YS, Boyko V, Fadeeva NV, Ursol GM, Ahn HK, Kislov NV, Shen CI, Davis C, Kowalski K, Michelon E, Pavlov D, Hirohashi T, Cho BC. Pharmacokinetics, safety, and efficacy of an alternative dosing regimen of sasanlimab in participants with advanced NSCLC and other malignancies. Ther Adv Med Oncol. 2024 Sep 11;16:17588359241274592. doi: 10.1177/17588359241274592. eCollection 2024. |
| 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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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1b Escalation 300 mg SC Q4W | PF-06801591 300 mg was given subcutaneously (SC) every 4 weeks (Q4W) (Cycles are 28 days in length). The maximum number of cycles was 9. |
| FG001 | Phase 1b Expansion 300 mg SC Q4W |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| TREATMENT |
|
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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 | Jun 24, 2020 | Feb 28, 2023 |
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| Number of Participants With Laboratory Abnormalities | Laboratory results were classified according to the NCI-CTCAE criteria version 5.0. Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care (ADL); Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Number of participants with Grade 1 to Grade 4 laboratory abnormalities were reported. | Phase 1b/2: On-treatment period is defined as the time from the first dose of study treatment through minimum (30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day). |
| Pharmacokinetic Parameters: AUCÏ„ After First Dose | This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). AUCÏ„ is area under the plasma concentration-time profile from time zero to the next dose (after single dose). (Ï„ = X days, where X = 28 days for Q4W regimen and 42 days for Q6W regimen) | Phase 1b/2: For the PF-06801591 300 mg SC Q4W arms, Cycle 1 Day 1, 8, 15, 22, Cycle 2 Day 1; for the PF-06801591 600 mg SC Q6W arms, Cycle 1 Day 1, 8, 15, 29, Cycle 2 Day 1 |
| Pharmacokinetic Parameters: Ctrough After First Dose | This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). Ctrough is pre-dose concentration after single dose (first dose). | Phase 1b/2: Cycle 2 Day 1 for all Arms |
| Pharmacokinetic Parameters: Ctrough at Steady State | This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). Steady state Ctrough is pre-dose concentration following multiple dosing at steady state (Week 12) | Phase 1b/2: For the PF-06801591 300 mg SC Q4W arms, Day 1 of Cycle 4; for the PF-06801591 600 mg SC Q6W arms, Day 1 of Cycle 3 |
| Number of Participants With Treatment-Induced Anti-Drug Antibody (ADA) /Neutralizing Antibodies (NAb) | This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). Treatment-induced ADA = Baseline ADA titer was missing or negative and participant had ≥1 post-treatment positive ADA titer (ADA titer greater than or equal to 99 with assay cut-point of 1.09). Treatment-induced NAb = Baseline NAb titer was missing or negative or ADA-negative and participant had ≥1 post-treatment positive NAb titer. | Phase 1b/2: Day 1 of Cycle 1, 2, 3, 4, 6, 8, 10 and end of treatment (EOT) for the PF-06801591 300 mg SC Q4W arms; Day 1 of Cycle 1, 2, 3, 4, 5, 7 and EOT for the PF-06801591 600 mg SC Q6W arms |
| Number of Participants With Objective Response (OR) | This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). OR was defined as confirmed best overall response (BOR) of complete response (CR) or partial response (PR) according to RECIST v1.1. Complete Response (CR): Complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). All target lesions must be assessed. Partial Response (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. | Phase 1b/2: Up to 30 months |
| Time to Response (TTR) | This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). TTR was defined for participants with confirmed objective response (CR or PR) as the time from the 'start date' to the date of first documentation of objective tumor response which is subsequently confirmed. | Phase 1b/2: Up to 30 months |
| Number of Participants With Objective Response (Complete Response + Partial Response) Reported by Baseline Programmed Death-Ligand 1 (PD-L1) Status (High, Low, and Unknown) | This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). OR was defined as confirmed BOR of CR or PR according to RECIST v1.1. CR: Complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). All target 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. PD-L1 expression was defined as the number of PD-L1 positive cells and/or qualitative assessment of PD-L1 staining on tumor and inflammatory cells in regions of interest that are defined by tumor cell morphology. | Phase 1b/2: Baseline up to 30 months |
| Chongqing |
| Chongqing Municipality |
| 400030 |
| China |
| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | 210008 | China |
| Huashan Hospital Affiliated to Fudan University | Shanghai | Shanghai Municipality | 201107 | China |
| National Cancer Center Hospital | Chuo-ku | Tokyo | 104-0045 | Japan |
| Russian Research Centre for Radiology and Surgical Technologies | Saint Petersburg | Pesochny | 197758 | Russia |
| Private Medical Institution "Euromedservice" | Pushkin | Sankt-Peterburg | 196603 | Russia |
| Klinika UZI 4D, LLC | Pyatigorsk | Stavropol Kray | 357502 | Russia |
| State budgetary institution of healthcare of Yaroslavl region "Clinical oncology hospital" | Yaroslavl | Yaroslavl Oblast | 150054 | Russia |
| Evimed Llc | Chelyabinsk | 454048 | Russia |
| Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine | Chelyabinsk | 454087 | Russia |
| Ars Medika Center, LLC | Kaliningrad | 236006 | Russia |
| GBUZ Regional Clinical Hospital of Kaliningrad region | Kaliningrad | 236016 | Russia |
| Enlimed Llc | Kopeysk | 456620 | Russia |
| Orenburg Regional Clinical Oncological Dispensary | Orenburg | 460021 | Russia |
| Russian Scientific Center For Radiology and Surgical Technologies | Pesochny | 197758 | Russia |
| LLC Medical Center "Magnit" | Saint Petersburg | 190005 | Russia |
| Llc "Mss" | Saint Petersburg | 191025 | Russia |
| North-West Medical Center | Saint Petersburg | 191119 | Russia |
| Road clinical clinic of JSC "RZD" | Saint Petersburg | 192007 | Russia |
| NS HI "Road Clinical Hospital of JSC "Russian Railways"" | Saint Petersburg | 195271 | Russia |
| Private Healthcare Institution "Clinical Hospital "RZD-Medicine" of St. Petersburg | Saint Petersburg | 195271 | Russia |
| LLC "Diagnostic center "Energo" | Saint Petersburg | 196247 | Russia |
| Medical University REAVIZ | Samara | 443001 | Russia |
| Medical University REAVIZ | Samara | 443011 | Russia |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Gachon University Gil Medical Center | Incheon | 21656 | South Korea |
| Severance Hospital, Yonsei Univ. Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | 807 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Limited Liability Company "MedX-ray International Group" | Pliuty Village | Kyiv Oblast | Ukraine |
| Asklepion Medical Center | Khodosovka | Kyivska Oblast | 08173 | Ukraine |
| "Medeya Sumy" LLC | Sumy | Sumska Oblast | 40021 | Ukraine |
| Communal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council | Dnipro | 49102 | Ukraine |
| LLC "AR DI PI Ukraine" | Dnipro | 49102 | Ukraine |
| Llc "Mdc Expert" | Dnipro | 49102 | Ukraine |
| Municipal Non-profit Enterprise "SubCarpathian Clinical Oncological Centre of Ivano-Frankivsk RC" | Ivano-Frankivsk | 76018 | Ukraine |
| Private Enterprise of Private Manufacturing Company "Acinus", Medical and Diagnostic Center | Kropyvnytskyi | 25006 | Ukraine |
| Medical centre "Verum" Limited Liability Company | Kyiv | 03039 | Ukraine |
| Vita Сom LLC | Kyiv | 03141 | Ukraine |
| The State Institution "Romodanov Neurosurgery Institute, | Kyiv | 04050 | Ukraine |
| Llc Medical Centre | Odesa | 65006 | Ukraine |
| Municipal Non-profit Enterprise Odesa Regional Clinical Hospital of Odesa Regional Council | Odesa | 65025 | Ukraine |
| Llc Lidermed | Odesa | 65062 | Ukraine |
| Municipal Non Profit enterprise of Sumy Regional Council "Sumy Regional Clinical Oncology Center" | Sumy | 40022 | Ukraine |
| Llc Medical Center Diamed | Uzhhorod | 88000 | Ukraine |
| MNPE Central City Clinical Hospital of Uzhhorod City Council | Uzhhorod | 88000 | Ukraine |
| Ðœunicipal non-profit enterprise "Zhytomyr Regional Oncology Dispensary" of Zhytomyr Regional Council | Zhytomyr | 10002 | Ukraine |
PF-06801591 300 mg was given SC Q4W (Cycles are 28 days in length). The maximum number of cycles was 20.
| FG002 | Phase 1b Escalation 600 mg SC Q6W | PF-06801591 600 mg was given SC every 6 weeks (Q6W) (Cycles are 42 days in length). The maximum number of cycles was 9. |
| FG003 | Phase 1b Expansion 600 mg SC Q6W | PF-06801591 600 mg was given SC Q6W (Cycles are 42 days in length). The maximum number of cycles was 8. |
| FG004 | Phase 2 300 mg SC Q4W | PF-06801591 300 mg was given SC Q4W (Cycles are 28 days in length). The maximum number of cycles was 28. |
| FG005 | Phase 2 600 mg SC Q6W | PF-06801591 600 mg was given SC Q6W (Cycles are 42 days in length). The maximum number of cycles was 18. |
| COMPLETED |
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| NOT COMPLETED |
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| FOLLOW-UP |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1b Escalation 300 mg SC Q4W | PF-06801591 300 mg was given subcutaneously (SC) every 4 weeks (Q4W) (Cycles are 28 days in length). The maximum number of cycles was 9. |
| BG001 | Phase 1b Expansion 300 mg SC Q4W | PF-06801591 300 mg was given SC Q4W (Cycles are 28 days in length). The maximum number of cycles was 20. |
| BG002 | Phase 1b Escalation 600 mg SC Q6W | PF-06801591 600 mg was given SC every 6 weeks (Q6W) (Cycles are 42 days in length). The maximum number of cycles was 9. |
| BG003 | Phase 1b Expansion 600 mg SC Q6W | PF-06801591 600 mg was given SC Q6W (Cycles are 42 days in length). The maximum number of cycles was 8. |
| BG004 | Phase 2 300 mg SC Q4W | PF-06801591 300 mg was given SC Q4W (Cycles are 28 days in length). The maximum number of cycles was 28. |
| BG005 | Phase 2 600 mg SC Q6W | PF-06801591 600 mg was given SC Q6W (Cycles are 42 days in length). The maximum number of cycles was 18. |
| 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 | ||||||||||
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| 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 | Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLT) | This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with first line (1L) and second line (2L) non-small cell lung cancer (NSCLC) (Phase 2). For the Phase 1b, any of the following AEs occurring during the DLT observation period (the first cycle of treatment) which were attributable to the investigational product were classified as DLTs: Grade 5 AE not clearly due to the underlying disease or extraneous causes; Hematologic toxicity; Non-Hematologic Toxicity; Delay of ≥ 3 weeks in receiving the next scheduled administration due to persisting treatment-related toxicities. | DLT-evaluable analysis set included all participants who received at least 1 dose of study treatment in the Phase 1b and either experienced DLT during the DLT-evaluation period or completed the DLT-evaluation period without DLT. | Posted | Count of Participants | Participants | Phase 1b: at the end of cycle 1 (28 days) for the PF-06801591 300 mg SC Q4W arms, and (42 days) for the PF-06801591 600 mg SC Q6W arms |
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| Primary | Phase 2: AUCτ of PF-06801591 at Steady State | This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). AUCτ is area under the plasma concentration-time profile from time zero to the next dose (at steady state, starting at Week 12). (τ = X days, where X = 28 days for Q4W regimen and 42 days for Q6W regimen) | Phase 2: The PK concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 reportable concentration measurement. Safety analysis set included all enrolled participants who received at least 1 dose of study drug. Here "Number of participants analyzed" signifies participants who had data available for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*hour per milliliter (μg*hr/mL) | Phase 2: Cycle 4 Day 1, 8, 15, 22 and Cycle 5 Day 1 for the PF-06801591 300 mg SC Q4W arm, and Cycle 3 Day 1, 8, 15, 29 and Cycle 4 Day 1 for the PF-06801591 600 mg SC Q6W arm |
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| Primary | Phase 2: Ctrough of PF-06801591 at Steady State, at Week 12 | This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). Steady state Ctrough is pre-dose concentration following multiple dosing at steady state (Week 12) | Phase 2: The PK concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 reportable concentration measurement. Safety analysis set included all enrolled participants who received at least 1 dose of study drug. Here "Number of participants analyzed" signifies participants who had data available for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (μg/mL) | Phase 2: Cycle 4 Day 1 for the PF-06801591 300 mg SC Q4W arm, and Cycle 3 Day 1 for the PF-06801591 600 mg SC Q6W arm |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events | This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Not Posted | Jun 2027 | Phase 1b/2: On-treatment period is defined as the time from the first dose of study treatment through minimum (30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day). | Participants | |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Laboratory Abnormalities | Laboratory results were classified according to the NCI-CTCAE criteria version 5.0. Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care (ADL); Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Number of participants with Grade 1 to Grade 4 laboratory abnormalities were reported. | Not Posted | Jun 2027 | Phase 1b/2: On-treatment period is defined as the time from the first dose of study treatment through minimum (30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day). | Participants | |||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Parameters: AUCÏ„ After First Dose | This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). AUCÏ„ is area under the plasma concentration-time profile from time zero to the next dose (after single dose). (Ï„ = X days, where X = 28 days for Q4W regimen and 42 days for Q6W regimen) | Not Posted | Jun 2027 | Phase 1b/2: For the PF-06801591 300 mg SC Q4W arms, Cycle 1 Day 1, 8, 15, 22, Cycle 2 Day 1; for the PF-06801591 600 mg SC Q6W arms, Cycle 1 Day 1, 8, 15, 29, Cycle 2 Day 1 | Participants | |||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Parameters: Ctrough After First Dose | This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). Ctrough is pre-dose concentration after single dose (first dose). | Not Posted | Jun 2027 | Phase 1b/2: Cycle 2 Day 1 for all Arms | Participants | |||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Parameters: Ctrough at Steady State | This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). Steady state Ctrough is pre-dose concentration following multiple dosing at steady state (Week 12) | Not Posted | Jun 2027 | Phase 1b/2: For the PF-06801591 300 mg SC Q4W arms, Day 1 of Cycle 4; for the PF-06801591 600 mg SC Q6W arms, Day 1 of Cycle 3 | Participants | |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Induced Anti-Drug Antibody (ADA) /Neutralizing Antibodies (NAb) | This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). Treatment-induced ADA = Baseline ADA titer was missing or negative and participant had ≥1 post-treatment positive ADA titer (ADA titer greater than or equal to 99 with assay cut-point of 1.09). Treatment-induced NAb = Baseline NAb titer was missing or negative or ADA-negative and participant had ≥1 post-treatment positive NAb titer. | Not Posted | Jun 2027 | Phase 1b/2: Day 1 of Cycle 1, 2, 3, 4, 6, 8, 10 and end of treatment (EOT) for the PF-06801591 300 mg SC Q4W arms; Day 1 of Cycle 1, 2, 3, 4, 5, 7 and EOT for the PF-06801591 600 mg SC Q6W arms | Participants | |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Objective Response (OR) | This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). OR was defined as confirmed best overall response (BOR) of complete response (CR) or partial response (PR) according to RECIST v1.1. Complete Response (CR): Complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). All target lesions must be assessed. Partial Response (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. | Not Posted | Jun 2027 | Phase 1b/2: Up to 30 months | Participants | |||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) | This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). TTR was defined for participants with confirmed objective response (CR or PR) as the time from the 'start date' to the date of first documentation of objective tumor response which is subsequently confirmed. | Not Posted | Jun 2027 | Phase 1b/2: Up to 30 months | Participants | |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Objective Response (Complete Response + Partial Response) Reported by Baseline Programmed Death-Ligand 1 (PD-L1) Status (High, Low, and Unknown) | This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). OR was defined as confirmed BOR of CR or PR according to RECIST v1.1. CR: Complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). All target 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. PD-L1 expression was defined as the number of PD-L1 positive cells and/or qualitative assessment of PD-L1 staining on tumor and inflammatory cells in regions of interest that are defined by tumor cell morphology. | Not Posted | Jun 2027 | Phase 1b/2: Baseline up to 30 months | Participants |
Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. 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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1b Escalation 300 mg SC Q4W | PF-06801591 300 mg was given subcutaneously (SC) every 4 weeks (Q4W) (Cycles are 28 days in length). The maximum number of cycles was 9. | 0 | 4 | 1 | 4 | 4 | 4 |
| EG001 | Phase 1b Expansion 300 mg SC Q4W | PF-06801591 300 mg was given SC Q4W (Cycles are 28 days in length). The maximum number of cycles was 20. | 0 | 12 | 2 | 12 | 11 | 12 |
| EG002 | Phase 1b Escalation 600 mg SC Q6W | PF-06801591 600 mg was given SC every 6 weeks (Q6W) (Cycles are 42 days in length). The maximum number of cycles was 9. | 1 | 6 | 0 | 6 | 6 | 6 |
| EG003 | Phase 1b Expansion 600 mg SC Q6W | PF-06801591 600 mg was given SC Q6W (Cycles are 42 days in length). The maximum number of cycles was 8. | 2 | 12 | 0 | 12 | 12 | 12 |
| EG004 | Phase 2 300 mg SC Q4W | PF-06801591 300 mg was given SC Q4W (Cycles are 28 days in length). The maximum number of cycles was 28. | 16 | 41 | 16 | 41 | 40 | 41 |
| EG005 | Phase 2 600 mg SC Q6W | PF-06801591 600 mg was given SC Q6W (Cycles are 42 days in length). The maximum number of cycles was 18. | 31 | 80 | 13 | 80 | 58 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Ventricular extrasystoles | Cardiac disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Inappropriate antidiuretic | Endocrine disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA v25.0 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA v25.0 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.0 | Non-systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v25.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Arrhythmia supraventricular | Cardiac disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Swelling | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA v25.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Blood corticotrophin decreased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Blood corticotrophin increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Blood thyroid stimulating hormone decreased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Cortisol decreased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Free thyroxine index increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Red blood cell count increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Thyroid hormones decreased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Total bile acids increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.0 | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Vitiligo | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
|
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 | Apr 7, 2022 | Feb 28, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| 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 |
Not provided
Not provided
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Other unspecified |
|
| Ongoing |
|
| 65 - <75 years |
|
| 75 - <85 years |
|
| ≥85 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| Multiracial |
|
| Not Reported |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Participants |
|
|
|