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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-517756-35-00 | Registry Identifier | CTIS (EU) |
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The trial was terminated for strategic business reasons; the decision was not based on any safety and/or efficacy concerns
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The purpose of this study is to learn about the effects of a new study medicine called PF-08046032, when taken alone and when taken with another medicine called sasanlimab, for the treatment of advanced cancers. The effects are studied in adult participants with certain types of lymphomas or solid tumors that are advanced or metastatic (spread to other parts of the body).
The study has three parts:
All participants will receive the study drug PF-08046032. Only participants in Part B and Part C of the study will also receive sasanlimab. PF-08046032 will be given as an intravenous (IV) infusion, which means it will be injected directly into a vein. Sasanlimab will be given as a subcutaneous injection, which means it will be injected under the skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-08046032 Monotherapy Dose Escalation | Experimental | PF-08046032 will be given as an intravenous (IV) infusion. |
|
| PF-08046032 + Sasanlimab Combination Safety Evaluation | Experimental | PF-08046032 will be given as an intravenous (IV) infusion and sasanlimab will be administered as a subcutaneous injection. |
|
| PF-08046032 + Sasanlimab Combination Expansion Cohort | Experimental | PF-08046032 will be given as an intravenous (IV) infusion and sasanlimab will be administered as a subcutaneous injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-08046032 | Drug | PF-08046032 will be administered intravenously (IV) infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A and Part B: Number of participants with dose limiting toxicities (DLTs) in dose escalation | DLT (any of the prespecified AEs that are attributable to study treatment(s), excluding toxicities clearly due to underlying disease or extraneous causes) rate estimated based on data from DLT-evaluable participants during the DLT evaluation period | Day of first dose (Day 1) through the end of DLT Observation period (up to 28 days) |
| All Parts: Number of participants with adverse events (AEs) | AEs as characterized by type, frequency, severity (CTCAE v5), seriousness, and relationship to study drug(s) | From first dose (Day 1) through up to 30 days after last dose of PF-08046032 or up to 90 days after last dose of sasanlimab |
| All Parts: Frequency of dose modifications due to AEs | Dose modifications such as dose delay, treatment interruptions, dose reducations, and treatment discontinuations due to AEs | From first dose (Day 1) through up to 30 days after last dose of PF-08046032 or up to 90 days after last dose of sasanlimab |
| All Parts: Number of participants with clinically significant lab abnormalities | Lab abnormalities characterized by type, frequency, and severity (CTCAE v5) | From first dose (Day 1) through up to 30 days after last dose of PF-08046032 or up to 90 days after last dose of sasanlimab |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) in Participants with Solid Tumors | Based on investigator assessment, and defined as the proportion of participants who achieved best overall response of CR or PR according to RECIST 1.1 | Response assessments at baseline and every 8 to 12 weeks through time of disease progression, death, unacceptable toxicity, or through study completion (Approximately 3 Years) |
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INCLUSION CRITERIA:
Histological or cytological diagnosis of metastatic or unresectable malignancy:
Measurable disease as defined by Lugano Classification for lymphomas or RECIST 1.1 for solid tumors
Able to provide tumor tissue(s) as defined by the protocol depending on the Part of the study at enrollment
ECOG Performance Status score 0 or 1
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NEXT Oncology | San Antonio | Texas | 78229 | United States | ||
| Fred Hutchinson Cancer Center. |
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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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| Sasanlimab | Drug | Sasanlimab will be administered as subcutaneous (SC) injection. |
|
| Duration of Response (DoR) in Participants with Solid Tumors | Based on investigator assessment for participants with a confirmed objective response (CR or PR) only. | Time from first documented objective response to the date of first documented radiographic progression or death (Approximately 3 Years) |
| Progression-free survival (PFS) in Participants with Solid Tumors | Based on investigator assessment for tumor response/progression according to RECIST v1.1 | Time from first dose (Day 1) to the date of first documented radiographic progression or death (Approximately 3 Years) |
| Objective Response Rate (ORR) in participants with lymphomas based on Lugano Criteria | Based on investigator assessment, and defined as the proportion of participants who achieved best overall response according to Lugano Criteria | Response assessments at baseline and every 8 to 12 weeks through time of disease progression, death, unacceptable toxicity, or through study completion (Approximately 3 Years) |
| Progression-free survival (PFS) in participants with lymphomas based on Lugano Criteria | Based on investigator assessment for tumor response/progression according to Lugano Response Classification Criteria | Time from first dose (Day 1) to the date of first documented radiographic progression or death (Approximately 3 Years) |
| Duration of Response (DoR) in participants with lymphomas based on Lugano Criteria | Based on investigator assessment for participants with a confirmed objective response only. | Time from first documented objective response to the date of first documented radiographic progression or death (Approximately 3 Years) |
| Complete Response Rate (CRR) in participants with lymphomas | Based on investigator assessment, and defined as the proportion of participants who achieved best overall response of Complete Response (CR) according to Lugano Criteria | Response assessments at baseline and every 8 to 12 weeks through time of disease progression, death, unacceptable toxicity, or through study completion (Approximately 3 Years) |
| Duration of Complete Response (DCR) in participants with lymphomas | Based on investigator assessment for participants with lymphoma with a confirmed objective response per Lugano Criteria only. | Time from first documented CR to the date of the first radiographic progression or death (Approximately 3 Years) |
| Part C only: Overall survival (OS) | OS is defined as time from first dose of study treatment to death due to any cause. | Baseline through date of death or study completion, whichever occurs first (up to approximately 3 Years) |
| Part A2 only: Change from baseline of the number of CD25+ cells in tumor in response to PF-08046032 treatment | Change is evaluated from paired biopsies | Baseline through about 7 weeks after first dose |
| Pharmacokinetics (PK): Serum Area Under the Curve (AUC) from Time Zero to Last Quantifiable Concentration (AUClast) | AUClast of PF-08046032 as a monotherapy (Part A) and in combination with sasanlimab (Part B and Part C). | Cycle 1 and Cycle 2, and pre-and post-dosing on Day 1 of Cycle 3, 4, 6, 8, and every 4th cycle thereafter; and within approximately 30 days after last dose of study drug (each cycle is 28 days) |
| PK: Maximum Observed Serum Concentration (Cmax) | Cmax of of PF-08046032 as a monotherapy (Part A) and in combination with sasanlimab (Part B and Part C). | Cycle 1 and Cycle 2, and pre-and post-dosing on Day 1 of Cycle 3, 4, 6, 8, and every 4th cycle thereafter; and within approximately 30 days after last dose of study drug (each cycle is 28 days) |
| PK: Half-life (t1/2) | Half life of PF-08046032 as a monotherapy (Part A) and in combination with sasanlimab (Part B and Part C) | Cycle 1 and Cycle 2, and pre-and post-dosing on Day 1 of Cycle 3, 4, 6, 8, and every 4th cycle thereafter; and within approximately 30 days after last dose of study drug (each cycle is 28 days) |
| PK: Minimum observed serum concentration (Ctrough) | Ctrough of PF-08046032 as a monotherapy (Part A) and in combination with sasanlimab (Part B and Part C) | Cycle 1 and Cycle 2, and pre-and post-dosing on Day 1 of Cycle 3, 4, 6, 8, and every 4th cycle thereafter; and within approximately 30 days after last dose of study drug (each cycle is 28 days) |
| PK: Time to Reach Maximum Observed Serum Concentration (Tmax) | Tmax of PF-08046032 as a monotherapy (Part A) and in combination with sasanlimab (Part B and Part C) | Cycle 1 and Cycle 2, and pre-and post-dosing on Day 1 of Cycle 3, 4, 6, 8, and every 4th cycle thereafter; and within approximately 30 days after last dose of study drug (each cycle is 28 days) |
| Incidence of Anti-Drug Antibody (ADA): Immunogenicity of PF-08046032 as a single agent (Part A) and in combination with sasanlimab (Part B and Part C) | Immunogenicity of PF-08046032 and in combination with sasanlimab | Pre-dose on Day 1 of Cycles 1-4, then cycle 6, 8, and every 4th cycle thereafter, and within approximately 30 days after last dose of study drug (each cycle is 28 days) |
| Seattle |
| Washington |
| 98109 |
| United States |
| University of Washington Medical Center- Montlake | Seattle | Washington | 98195 | United States |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | 28040 | Spain |
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D008545 | Melanoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| D012878 | Skin Neoplasms |
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D006258 | Head and Neck Neoplasms |
| D009362 | Neoplasm Metastasis |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009371 | Neoplasms by Site |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006402 | Hematologic Diseases |
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