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PF-08046876

Phase 1

Advanced/Metastatic Solid Tumors | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Sep 4, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment310

FDA Designations

No designations recorded

Clinical trial landscape

PF-08046876 · 1 trial · 13 indications

Phase 1 1
NCT07090499A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid TumorsAdvanced/Metastatic Solid Tumors
RECRUITING540 Analytics
PHASE1RECRUITING
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Treatment Emergent Adverse Events (TEAEs) estimated during the Adverse Events (AE) evaluation
Start of treatment up to 30 days after last dose or start of new anticancer therapy (whichever occurs first)

AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy dose modifications.

Part 1: Number of Participants With Dose-limiting Toxicities (DLTs): Monotherapy
Baseline to end of DLT evaluation period

Occurrence of DLTs as defined by the protocol

Part 1: Recommended Monotherapy Dose for Expansion
Baseline to 30 days post last study drug administration

RDE will be based on cumulative safety, preliminary antitumor activity and pharmacokinetics findings

Part 2: Recommended Phase 2 Dose
Baseline to 30 days post last study drug administration

RP2D will be determined based on the cumulative safety, preliminary anti tumor activity and Pharmacokinetics findings.

Secondary Endpoints

Objective Response Rate (ORR)
Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years)
Duration of Response (DOR)
From the date of the first objective response to the date of disease progression or death (approximately 2 years)
Progression Free Survival (PFS)
From Baseline to date of first disease progression or death (approximately 2 Years)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1 Dose EscalationEXPERIMENTALDifferent groups of participants will receive different doses and/or schedules of the study drug
Part 2 Dose OptimizationEXPERIMENTALParticipants will be randomized to 2 dosing regimens deemed to be safe in Part 1
Part 2 Dose ExpansionEXPERIMENTALParticipants in tumor-specific groups will receive 1 dosing regimen deemed to be safe in Part 1

Interventions

NameTypeDescription
PF-08046876DRUGIntravenous administration
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites31

Inclusion Criteria: * 18 years of age or older * Advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas * Measurable disease * ECOG Performance status 0-1 * Part 1: progression or relapse following standard treatments * Part 2: maximum of 2 prior lines of systemic therapy in th...

Countries:United StatesCanadaChinaPuerto RicoSpainUnited Kingdom
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced/Metastatic Solid Tumors")

Recent Changes (Last 90 Days)

LOWSep 4, 2026NCT07090499Enrollment: 310 → 540
LOWJul 22, 2026NCT07090499lastUpdatePostDate: changed
LOWJul 22, 2026NCT07090499lastUpdatePostDate: changed

Frequently asked questions about PF-08046876

What is PF-08046876 used for?

PF-08046876 is an investigational small molecule being studied for the treatment of advanced or metastatic solid tumors, including bladder cancer, urothelial carcinoma, advanced non-small cell lung cancer, head and neck cancer, esophageal cancer, gastroesophageal junction adenocarcinoma, pancreatic adenocarcinoma, and pancreatic cancer.

Who makes PF-08046876?

PF-08046876 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE.

What phase is PF-08046876 in?

PF-08046876 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. It is currently being evaluated in a Phase 1 study for safety and tolerability in patients with advanced solid tumors.

What clinical trials is PF-08046876 in?

PF-08046876 is being studied in one active clinical trial, NCT07090499, a Phase 1 study in people with advanced solid tumors. The trial is recruiting 310 participants across the United States, Canada, Puerto Rico, Spain, and the United Kingdom.

Is PF-08046876 the same as any other drug?

No alternative names for PF-08046876 have been disclosed. It is identified solely by its code name PF-08046876 in clinical trial records.