Recent Updates
Recently added Catalysts

PF-05082566

Phase 3

Advanced Solid Tumors | Small molecule | Oncology |Pfizer, Inc.|Trials Updated: Mar 17, 2020

PF-05082566 development status

Highest phase Phase 3 (NCT02951156)
Phase scored for PFEPhase 1
Registered trials 9 across 4 sponsors since Mar 2011

PF-05082566 target and mechanism

ModalitySmall molecule

Also known as Utomilumab

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment213

FDA Designations

No designations recorded

PF-05082566 clinical trials

PF-05082566 · 2 trials · 8 indications

Phase 1 2
NCT02179918A Study Of 4-1BB Agonist PF-05082566 Plus PD-1 Inhibitor MK-3475 In Patients With Solid Tumors (B1641003/KEYNOTE-0036)Advanced Solid Tumors
COMPLETED23 Analytics
NCT01307267A Study Of PF-05082566 As A Single Agent And In Combination With RituximabLymphoma, Non-Hodgkin
COMPLETED190 Analytics
PHASE1COMPLETED
A Study Of 4-1BB Agonist PF-05082566 Plus PD-1 Inhibitor MK-3475 In Patients With Solid Tumors (B1641003/KEYNOTE-0036)
Advanced Solid TumorsUnlock trial analytics
PHASE1COMPLETED
A Study Of PF-05082566 As A Single Agent And In Combination With Rituximab
Lymphoma, Non-HodgkinUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Dose-Limiting Toxicities (DLT) of PF-05082566 in Combination With MK-3475
First 2 cycles of treatment up to 24 months

Severity of adverse events (AEs) was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For the purpose of dose escalation, any of the following AEs occurring during the DLT observation period that were attributable to one or both study drugs were classified as DLTs. 1) Hematologic: Grade 4 neutropenia; Febrile neutropenia, defined as absolute neutrophil count (ANC) \<1000/mm3 with a single temperature of \>38.3C(101F) or a sustained temperature of 38C (100.4F) for more than 1 hour; Grade\>=3 neutropenic infection; Grade\>=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia. 2) Non hematologic: Grade\>=3 toxicities (non-laboratory); Grade\>=3 nausea, vomiting or diarrhea despite maximal medical therapy; Grade 4 aspartate aminotransferase (AST) and alanine aminotransferase (ALT). 3) Other (non-AST/ALT) non-hematologic Grade\>=3 laboratory value. 4) Inability to complete 2 infusions of MK-3475 and PF-05082566 during the DLT observation period.

Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A
Cycle 1 Day 1 to Cycle 2 Day 29 in Portion A (up to 57 days, each cycle = 28 days)

DLT: Any of the following adverse events (AEs) occurred in the first 2 cycles of treatment (up to 28 days post second dose) which was attributed to PF-05082566 alone for Portion A and not related to progressive disease. Hematologic: Grade 4 neutropenia lasting more than (\>)7 days; febrile neutropenia; neutropenic infection; Grade ≥3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia; Grade ≥3 hemolysis. Non-Hematologic: Grade ≥3 toxicities, except those Grade 3 events that responded to treatment (eg, Grade 3 nausea, vomiting, diarrhea responding to standard medical supportive care within 48 hours would not be considered a DLT). Severity of AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). Each cycle=28 days.

Number of Participants With DLTs in First 2 Cycles of Portion B
Cycle 1 Day 1 to Cycle 2 Day 29 in Portion B (up to 57 days, each cycle = 28 days)

DLT: Any of the following AEs occurred in the first 2 cycles of treatment (up to 28 days post second dose) which was attributed to PF-05082566 in combination with rituximab for Portion B and not related to progressive disease. Hematologic: Grade 4 neutropenia lasting more than (\>)7 days; febrile neutropenia; neutropenic infection; Grade ≥3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia; Grade ≥3 hemolysis. Non-Hematologic: Grade ≥3 toxicities, except those Grade 3 events that responded to treatment (eg, Grade 3 nausea, vomiting, diarrhea responding to standard medical supportive care within 48 hours would not be considered a DLT). Severity of AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). Each cycle=28 days.

Secondary Endpoints

Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities)
Baseline up to 90 days after the last dose of study drug, approximately 27 months
Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related)
Baseline up to 90 days after the last dose of study drug, approximately 27 months
Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related)
Baseline up to 90 days after the last dose of study drug, approximately 27 months
Unlock Study Endpoints

Study Design & Arms

MaskingNONE
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PF-05082566 +MK-3475EXPERIMENTALPF-05082566 +MK-3475
Portion AEXPERIMENTALPF-05082566 single agent in patients with advanced cancer
Portion BEXPERIMENTALPF-05082566 in combination with rituximab in patients with Non-Hodgkin's Lymphoma

Interventions

NameTypeDescription
PF-05082566DRUGStarting dose of 0.45 mg/kg q3wks IV, dose escalation
MK-3475DRUG2 mg/kg q3wks, IV
rituximabDRUGIntravenous, 375 mg/m2, once per week for 4 weeks
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy which has progressed on standard therapy or for which no standard therapy is available. * Measurable disease per RECIST v1.1. * Adequate bone marrow, renal and liver functioning Exclusion Crit...

Countries:United StatesAustraliaFranceItalyJapan
Unlock Eligibility Criteria

Competitive Landscape -Other Solid Tumors 10 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about PF-05082566

What is PF-05082566 used for?

PF-05082566 is an investigational oncology drug being studied for the treatment of non-Hodgkin lymphoma, follicular lymphoma, diffuse large B-cell lymphoma, advanced solid tumors, non-small-cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck, and malignant melanoma. It is a small molecule in Phase 1 clinical development.

What does PF-05082566 target?

PF-05082566 is a 4-1BB agonist, meaning it targets the 4-1BB receptor, a costimulatory molecule on immune cells. By activating 4-1BB, the drug is designed to enhance the immune system's anti-tumor response. This mechanism is being evaluated in the context of cancer immunotherapy.

Who makes PF-05082566?

PF-05082566 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical trials for various oncology indications.

What phase is PF-05082566 in?

PF-05082566 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, one as a single agent and in combination with rituximab, and another in combination with a PD-1 inhibitor.

What clinical trials is PF-05082566 in?

PF-05082566 has been studied in two completed Phase 1 trials. NCT01307267 evaluated the drug as a single agent and in combination with rituximab in patients with lymphomas and solid tumors. NCT02179918 evaluated PF-05082566 plus the PD-1 inhibitor MK-3475 in patients with advanced solid tumors.

Is PF-05082566 the same as utomilumab?

PF-05082566 is also known as utomilumab. It is a 4-1BB agonist being developed by Pfizer for the treatment of various cancers. The drug has been studied in clinical trials as a single agent and in combination with other therapies, including rituximab and a PD-1 inhibitor.