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PF-05082566

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment23

FDA Designations

No designations recorded

Clinical trial landscape

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
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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
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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
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about PF-05082566

What is PF-05082566 used for?

PF-05082566 is an investigational small molecule being studied for the treatment of advanced solid tumors, lymphoma, and non-Hodgkin lymphoma. It has been evaluated in clinical trials for conditions including follicular lymphoma, diffuse large B-cell lymphoma, non-small-cell lung carcinoma, renal cell carcinoma, squamous cell carcinoma of the head and neck, and malignant melanoma.

How does PF-05082566 work?

PF-05082566 is a 4-1BB agonist, meaning it targets and activates the 4-1BB receptor, a costimulatory molecule on immune cells. By stimulating 4-1BB, it is designed to enhance the activity of T cells and other immune cells to promote an anti-tumor immune response.

Who is developing PF-05082566?

PF-05082566 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug is an investigational oncology therapy in Phase 1 clinical development.

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. Clinical trials have been completed, and the drug remains under investigation for its safety and efficacy in treating certain cancers.

What clinical trials is PF-05082566 in?

PF-05082566 has been studied in two completed Phase 1 clinical trials. The first, NCT01307267, evaluated the drug as a single agent and in combination with rituximab in patients with lymphoma and other cancers. The second, NCT02179918, studied the drug in combination with the PD-1 inhibitor pembrolizumab in patients with advanced solid tumors.

Is PF-05082566 the same as utomilumab?

PF-05082566 is also known as utomilumab. This alternative name is used in some clinical and scientific contexts to refer to the same investigational drug developed by Pfizer.