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A Study to Learn About the Study Medicine Called PF-08046031 in Advanced Melanoma and Other Solid Tumors

Description

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.

Conditions

Malignant MelanomaMelanomaMetastatic MelanomaSolid Tumors
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Related Conditions:

Malignant MelanomaMelanomaMetastatic MelanomaSolid Tumors

Study Overview

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Study Details

Study overview

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.

AN OPEN-LABEL PHASE 1 STUDY TO INVESTIGATE PF-08046031 IN ADULTS WITH ADVANCED MELANOMA AND OTHER SOLID TUMORS

A Study to Learn About the Study Medicine Called PF-08046031 in Advanced Melanoma and Other Solid Tumors

Condition
Malignant Melanoma
Intervention / Treatment

-

Contacts and Locations

Los Angeles

The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate, Los Angeles, California, United States, 90025

Santa Monica

The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate (Emergency Back-up only), Santa Monica, California, United States, 90404

Denver

Presbyterian/St. Luke's Medical Center, Denver, Colorado, United States, 80218

Orlando

Florida Cancer Specialists, Orlando, Florida, United States, 32827

Orlando

Sarah Cannon Research Institute at Florida Cancer Specialists, Orlando, Florida, United States, 32827

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participants in Part 1 (dose escalation) must have histologically- or cytologically-confirmed metastatic or unresectable cutaneous melanoma. They must have progressive disease following at least 1 prior anti programmed death-1 (PD 1)/programmed death-ligand 1 (PD L1) immunotherapy containing regimen (either as monotherapy, or in combination with other checkpoint inhibitors or other therapies) and should have no appropriate standard therapy available at the time of enrollment in the judgment of the investigator.
  • * Participants in Part 2 (dose optimization) must have histologically- or cytologically-confirmed metastatic or unresectable cutaneous melanoma. They must have progressive disease following at least 1 prior anti PD 1/PD L1 immunotherapy containing regimen (either as monotherapy, or in combination with other checkpoint inhibitors or other therapies) but not more than 2 total prior lines of systemic therapy.
  • * For Part 3 (dose expansion): Participants must have histologically- or cytologically confirmed metastatic or unresectable solid malignancy from 1 of the following tumor types: cutaneous melanoma, NSCLC, HNSCC, esophageal cancer.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pfizer,

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

2030-06-07