The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
PF-08046032 is an investigational compound. Its safety and efficacy have not been established
Active enrolling
United States, Spain
EXPERIMENTAL: PF-08046032 Monotherapy Dose Escalation
PF-08046032 will be given as an intravenous (IV) infusion.
DRUG: PF-08046032
PF-08046032 will be administered intravenously (IV) infusion.
EXPERIMENTAL: PF-08046032 + Sasanlimab Combination Safety Evaluation
PF-08046032 will be given as an intravenous (IV) infusion and sasanlimab will be administered as a subcutaneous injection.
DRUG: PF-08046032
PF-08046032 will be administered intravenously (IV) infusion.
DRUG: Sasanlimab
Sasanlimab will be administered as subcutaneous (SC) injection.
EXPERIMENTAL: PF-08046032 + Sasanlimab Combination Expansion Cohort
PF-08046032 will be given as an intravenous (IV) infusion and sasanlimab will be administered as a subcutaneous injection.
DRUG: PF-08046032
PF-08046032 will be administered intravenously (IV) infusion.
DRUG: Sasanlimab
Sasanlimab will be administered as subcutaneous (SC) injection.
INCLUSION CRITERIA: 1. Histological or cytological diagnosis of metastatic or unresectable malignancy: * Part A1: Participants with lymphomas (cHL, PTCL, large B-cell lymphoma) who have progressed on/after standard therapies * Part A2: Participants with solid tumors (NSCLC, HNSCC, melanoma, or other limited tumor types) who have progressed on or following prior immune checkpoint inhibitor if indicated and available * Part B: Participants with solid tumors who have either progressed on/after prior immune checkpoint inhibitor, or who have not received prior immune checkpoint inhibitor therapy * Part C: Participants with selected tumor type who have not received systemic anticancer treatment for the tumor type (including prior immune checkpoint inhibitor 2. Measurable disease as defined by Lugano Classification for lymphomas or RECIST 1.1 for solid tumors 3. Able to provide tumor tissue(s) as defined by the protocol depending on the Part of the study at enrollment 4. ECOG Performance Status score 0 or 1
1. Ongoing peripheral neuropathy 2. History of significant immune-mediated adverse event considered related to prior immune-modulatory therapy 3. Known or suspected active autoimmune disease
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
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)
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)
220
Sponsor: Pfizer
Collaborator: None
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number:
NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
NCT06870487
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