A Study of PF-08046876 for Advanced Solid Tumors

This study is testing a new treatment called PF-08046876 for people with advanced bladder, lung, head and neck, esophagus, or pancreas cancer. PF-08046876 is an "antibody drug conjugate" (ADC), which is a type of medicine designed to find and kill cancer cells. You would receive PF-08046876 through an IV (a needle in your vein). The main goal is to see how safe PF-08046876 is and what side effects it might cause. Researchers will also look at the highest dose that can be given safely. This study is currently recruiting up to 310 participants.

Study design
This is an interventional study, meaning participants will receive the study drug. It involves different groups receiving varying doses of PF-08046876.
What's involved
Participants will receive PF-08046876 intravenously. The study will monitor for side effects from the start of treatment up to 30 days after the last dose or starting new cancer therapy.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for side effects for up to 30 days after their last dose of PF-08046876 or until they start a new anticancer therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07090499

A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Pfizer
~310 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:PF-08046876

At a glance

Recruiting sites
25 of 30 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment Emergent Adverse Events (TEAEs) estimated during the Adverse Events (AE) evaluation
Measured over Start of treatment up to 30 days after last dose or start of new anticancer therapy (whichever occurs first)
+3 more outcomes measured
Advanced/Metastatic Solid Tumors
Bladder Cancer
Urothelial Carcinoma
Advanced Non-Small Cell Lung Cancer
Carcinoma, Non Small Cell Lung
Carcinoma, Squamous Cell of Head and Neck
Head and Neck Cancer
Esophageal Cancer
Gastroesophageal Junction Adenocarcinoma
Esophageal Squamous Cell Carcinoma
Esophageal Adenocarcinoma
Pancreatic Adenocarcinoma
Pancreatic Cancer
30 sites across 12 states
California6
Texas6
Connecticut4
Massachusetts3
Tennessee2
Ontario2
United Kingdom2
Quebec1
  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

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Eligibility criteria

Inclusion

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 the advanced setting
Resolution of acute effects of prior anticancer therapy to baseline or Grade 1
Consent to submit required pre-treatment tumor tissue as medically feasible

Exclusion

Received prior treatment with an antibody drug conjugate with a camptothecin-class payload (e.g. sacituzumab govitecan, trastuzumab deruxtecan )
Active anorexia, nausea or vomiting, and/or signs of intestinal obstruction meeting protocol exclusion
Pulmonary disease meeting protocol exclusion
Other unacceptable abnormalities as defined by protocol
  • Incidence of Treatment Emergent Adverse Events (TEAEs) estimated during the Adverse Events (AE) evaluationStart 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): MonotherapyBaseline to end of DLT evaluation period

    Occurrence of DLTs as defined by the protocol

  • Part 1: Recommended Monotherapy Dose for ExpansionBaseline 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 DoseBaseline to 30 days post last study drug administration

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