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

Launched by PFIZER · Jan 23, 2025

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ClinConnect Summary

This clinical trial is studying a new medicine called PF-08046031, which is being tested for safety and effectiveness in treating advanced melanoma and other solid tumors. These are types of cancer that have either spread in the body or have no available approved treatment options. The trial is divided into three parts: the first two parts will help determine the right dosage of the medicine, while the third part will assess how safe the medicine is and whether it can help treat these cancers.

To be eligible for this trial, participants must have a specific type of melanoma that has not responded to at least one prior treatment involving immunotherapy, which is a type of treatment that helps the immune system fight cancer. Participants should also have measurable disease that can be tracked. Throughout the study, participants will receive the study medicine and be monitored for any side effects, which are any unwanted reactions the body may have to the drug. This trial is not yet recruiting participants, so interested individuals should keep an eye out for updates.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 Measurable disease per RECIST v1.1 at baseline
• Exclusion Criteria:
• • 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
• • Other protocol specific criteria might apply.
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