250 Participants NeededMy employer runs this trial

PF-08046033 for Cancer

Recruiting at 14 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Pfizer
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cancer treatment called PF-08046033. The main goals are to determine the medicine's safety, its effects in the body, and its potential to treat advanced cancers such as non-small cell lung cancer, esophageal squamous cell cancer, and melanoma. In the first part, participants receive varying doses to identify the safest option. The second part involves more participants to assess the medicine's effectiveness against specific cancers. Individuals with advanced cancer that hasn't responded to standard treatments and who have noticeable symptoms might be suitable for this study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that PF-08046033 is likely to be safe for humans?

Research has shown that PF-08046033 remains in the early testing stages to assess its safety and tolerability. Scientists are beginning to understand how people react to it. As a Phase 1 trial, the primary goal is to determine the treatment's safety for humans. Participants receive varying doses to identify the maximum amount they can tolerate without issues.

Previous studies have not provided detailed information on side effects or tolerability. However, since it is in Phase 1, the focus remains on ensuring it does not cause serious harm. Researchers closely monitor participants for any side effects, and the results will guide decisions on advancing to more extensive testing.12345

Why do researchers think this study treatment might be promising?

PF-08046033 is unique because it targets cancer cells in a way that's different from standard chemotherapy and immunotherapy options. Unlike traditional treatments that might broadly attack both healthy and cancerous cells, PF-08046033 is designed to work more precisely, potentially minimizing damage to healthy tissues. Researchers are excited about this treatment because it might offer a more targeted approach, which could lead to fewer side effects and better outcomes for patients with various types of cancer, including melanoma, esophageal squamous cell carcinoma, and non-small cell lung cancer.

What evidence suggests that PF-08046033 might be an effective treatment for cancer?

Research has shown that PF-08046033 is a promising new treatment for certain solid tumors. This drug combines an antibody with a drug to specifically target cancer cells. Early results suggest it could help control the growth of advanced cancers like non-small cell lung cancer and melanoma. It blocks a protein called β-tubulin, crucial for cell division, potentially slowing or stopping cancer cell multiplication. Although human studies have provided limited information, the science behind PF-08046033 offers researchers hope for its effectiveness. Participants in this trial will receive different dose levels of PF-08046033, based on their assigned cohort, to evaluate its safety and efficacy across various cancers.13467

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for adults with advanced or spreading melanoma, non-small cell lung cancer, or esophageal squamous cell cancer that can't be removed by surgery and has worsened after standard treatments. Participants must be in good physical condition and have measurable disease.

Inclusion Criteria

I have confirmed advanced or metastatic NSCLC, ESCC, or skin melanoma.
My disease got worse or I can't tolerate standard treatments or 1-2 prior therapies.
Participants must have measurable disease
See 1 more

Exclusion Criteria

I have been treated with a GPNMB-targeted therapy before.
I have moderate or severe nerve damage symptoms.
Known or suspected hypersensitivity to any component or excipient contained in the drug formulation of study intervention
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Small groups of participants receive increasing doses of PF-08046033 to find a safe and suitable dose for further testing

Up to 1 year
Regular treatment cycles

Dose Expansion

More participants with specific cancer types receive the identified suitable dose to better understand safety and efficacy

Up to 1 year
Regular treatment cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

30-37 days after the last study treatment

What Are the Treatments Tested in This Trial?

Interventions

  • PF-08046033

Trial Overview

The study tests a new drug called PF-08046033 to find a safe dose and see how it works in the body. Small groups get increasing doses at first; later, more people join to further check safety and early signs of effectiveness against certain cancers.

How Is the Trial Designed?

10

Treatment groups

Experimental Treatment

Group I: Part 2: Cohort 3 (Cutaneous Melanoma)Experimental Treatment1 Intervention
Group II: Part 2: Cohort 2 Esophageal Squamous Cell Carcinoma (ESCC)Experimental Treatment1 Intervention
Group III: Part 2: Cohort 1 Non-Small Cell Lung Cancer (NSCLC)Experimental Treatment1 Intervention
Group IV: Part 1: Cohort 7Experimental Treatment1 Intervention
Group V: Part 1: Cohort 6Experimental Treatment1 Intervention
Group VI: Part 1: Cohort 5Experimental Treatment1 Intervention
Group VII: Part 1: Cohort 4Experimental Treatment1 Intervention
Group VIII: Part 1: Cohort 3Experimental Treatment1 Intervention
Group IX: Part 1: Cohort 2Experimental Treatment1 Intervention
Group X: Part 1: Cohort 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

Phase 1 Study of PF-08046033 in Advanced Solid Tumors

The study includes adult participants who have advanced cancers that cannot be removed by surgery or have spread to other parts of the body.

Clinical Trial Details | Pfizer Oncology Development Website

CD25V Directed Antibody Drug Conjugate. PF-08046032 is an investigational compound. Its safety and efficacy have not been established ...

Phase 1 Study of PF-08046033 in Advanced Solid Tumors

The study includes adult participants who have advanced cancers that cannot be removed by surgery or have spread to other parts of the body.

Pfizer tries to banish the ghost of Celldex | ApexOnco

The phase 1 solid tumour study, which clinicaltrials.gov says began at the start of this month, should show whether PF-08046033 might overcome ...

PF-08046033 / Pfizer

PF-08046033 (GPS): A novel first in class auristatin S antibody-drug conjugate for treatment of GPNMB-expressing solid tumors (AACR 2026) ; Phase 1 Study of PF- ...

Phase 1 Study of PF-08046033 in Advanced Solid Tumors

The goal of the study is to understand how safe the medicine is, how well people tolerate it, how it behaves in the body, and whether it shows early signs of ...

PF-08046033 for Cancer

This Phase 1 medical study run by Pfizer is evaluating whether PF-08046033 will have tolerable side effects & efficacy for patients with ...