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

Stopped early · Phase 1

Conditions studied: Malignant Melanoma, Melanoma, Metastatic Melanoma, Solid Tumors

In brief

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.

Key facts

Study ID

NCT06799533

Run by

Pfizer

People needed

11

Starts

2025-05-01

Expected to finish

2026-02-23

Last updated by the study team

2026-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 and should have no appropriate standard therapy available at the time of enrollment in the judgment of the investigator.
• 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.
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 Measurable disease per RECIST v1.1 at baseline
• Participants who have refused available standard of care therapies are not eligible.

You may not qualify if…

• Active cerebral/meningeal disease related to the underlying malignancy. Previous exposure to CD228-targeted therapy, vedotin or an MMAE-containing agent, or any taxane containing regimen for advanced disease.
• Melanoma subtypes including uveal, and mucosal are excluded. Chemotherapy, definitive radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study intervention, or within 2 weeks prior to first dose of study intervention if the underlying disease has progressed on treatment
• Grade 3 or higher pulmonary disease unrelated to underlying malignancy. Previous history of non-infectious interstitial lung disease (ILD) or pneumonitis that required steroids, current ILD or pneumonitis, or suspected ILD or pneumonitis that cannot be ruled out by imaging at screening.
• Other protocol specific criteria might apply.

Where it is running

• The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate — Los Angeles, California, United States
• The Angeles Clinic And Research Institute, A Cedars-Sinai Affiliate — Los Angeles, California, United States
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• UCSF Medical Center, Investigational Pharmacy — San Francisco, California, United States
• The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate (Emergency Back-up only) — Santa Monica, California, United States
• Presbyterian/ St. Lukes Medical Center — Denver, Colorado, United States
• Sarah Cannon Research Institute at HealthONE - SCRI - PPDS — Denver, Colorado, United States
• Gustave Roussy — Villejuif, Val-de-marne, France
• Hospital Universitari Vall d'Hebron — Barcelona, Barcelona [barcelona], Spain
• Karolinska Universitetssjukhuset Solna — Solna, Stockholms LÄN [se-01], Sweden
• The Royal Marsden NHS Foundation Trust — Sutton, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.