250 Participants NeededMy employer runs this trial

PF-08046033 for Cancer

Recruiting at 5 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 is an early-stage (Phase 1) clinical study testing a new study medicine called PF-08046033. 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 helping to treat cancer.

The study includes adult participants who have advanced cancers that cannot be removed by surgery or have spread to other parts of the body. These cancers include non-small cell lung cancer, esophageal squamous cell cancer, and melanoma.

The study has two parts:

In the first part, small groups of participants receive increasing doses of the study medicine. This helps researchers find a dose that is safe and suitable for further testing.

Once a suitable dose is identified, the second part enrolls more participants with specific cancer types to better understand the safety of the medicine and whether it shows signs of helping control the cancer.

Participants receive the study medicine through regular treatment cycles and are closely monitored for side effects and how their cancer responds. The information from this study will help researchers decide whether PF-08046033 should be studied further in later-stage clinical trials.

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

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

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