PF-08046031 for Melanoma

Recruiting at 5 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Must not be taking: Taxanes, Vedotin, MMAE

Disqualifiers: Active cerebral disease, Uveal melanoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

185 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will test the safety of a drug called PF-08046031 in participants with melanoma and other solid tumors that have no current approved treatment or have spread through the body. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease. The study will have 3 parts. Part A and B of the study will find out how much PF-08046031 should be given to participants. Part C will use the information from Parts A and B to see if PF-08046031 is safe and if it works to treat solid tumor cancers.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for people with advanced melanoma or other solid tumors that have spread and don't respond to standard treatments. Participants must have tried at least one immunotherapy regimen and can't have more than two prior systemic therapies. They should be in good physical condition, as measured by an ECOG score of 0 or 1.

Inclusion Criteria

I am very active or have minor symptoms and my cancer can be measured by standard health scans.

I have advanced melanoma that didn't respond to initial immunotherapy.

I have advanced melanoma and my cancer progressed after 1-2 treatments including anti PD-1/PD-L1.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Determine the appropriate dosage of PF-08046031 for participants

Approximately 6 months

Treatment Part B

Further dosage determination and safety assessment of PF-08046031

Approximately 6 months

Treatment Part C

Evaluate the safety and efficacy of PF-08046031 using information from Parts A and B

Approximately 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 1 year

Treatment Details

Interventions

• PF-08046031

Trial Overview The study tests the safety and effectiveness of a new drug called PF-08046031 for treating melanoma and other solid tumors. It has three parts: determining the right dose, optimizing it, and then expanding the trial to see if it's safe across different tumor types.

Participant Groups

Group I: PF-08046031 monotherapy Experimental Treatment 1 Intervention

PF-08046031

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

Pfizer

Chief Medical Officer

MD from McGill University