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Phase 1 Study of PF-08046033 for Advanced Solid Tumors

This is an early-stage (Phase 1) study testing a new medicine called PF-08046033. The main goals are to understand how safe PF-08046033 is, how well people tolerate it, how it moves through the body, and if it shows early signs of helping to treat cancer. You may be able to join if you are an adult with advanced non-small cell lung cancer, esophageal squamous cell cancer, or cutaneous melanoma that has progressed after standard treatments or if you cannot tolerate those treatments. The study will look at any side effects, changes in lab tests, and if dose adjustments are needed to find a safe and effective dose.

Study design
This is an early-stage (Phase 1) interventional study aiming to enroll 250 participants. It involves giving increasing doses of PF-08046033 to small groups of participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events, lab abnormalities, and dose modifications from the first day through 30-37 days after the last study treatment, for up to approximately 1 year.

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

NCT07519655

Phase 1 Study of PF-08046033 in Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Pfizer
~250 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:PF-08046033

At a glance

Recruiting sites
13 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Type, incidence and severity of participants with adverse events (AEs)
Measured over From the first day through 30-37 days after the last study treatment, up to approximately 1 year
+4 more outcomes measured

Conditions

Non-Small-Cell Lung
Esophageal Cancer
Cutaneous Melanoma

Explore related trials

Esophageal Squamous Cell CarcinomaLung Non-Small Cell CarcinomaMelanoma

Where it's being run

15 sites across 6 states
Connecticut5
Colorado2
Tennessee2
Virginia2
Puerto Rico2
Seoul-teukbyeolsi [seoul]2

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

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What this trial measures

  • Type, incidence and severity of participants with adverse events (AEs)From the first day through 30-37 days after the last study treatment, up to approximately 1 year

    Type, incidence, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v 5.0), seriousness, and relatedness of adverse events (AEs).

  • Type, incidence, and severity of participants with laboratory abnormalitiesFrom the first day through 30-37 days after the last study treatment, up to approximately 1 year

    Type, incidence, and severity (graded by NCI CTCAE version 5.0) of laboratory abnormalities

  • Number of participants with dose modificationsFrom the first day through 30-37 days after the last study treatment, up to approximately 1 year

    Frequency of dose modifications (eg, dose delay and treatment discontinuations) due to AEs

  • Incidence of dose-limiting toxicities (DLTs)From the first day through 30-37 days after the last study treatment, up to approximately 1 year

    To identify the maximum tolerated dose (MTD) or maximum administered dose (MAD) of PF-08046033

  • Recommended dose and schedule of PF-08046033 for expansion (RDE)Up to 1 year

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