Status and phase
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About
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.
Enrollment
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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.
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.
Primary purpose
Allocation
Interventional model
Masking
185 participants in 1 patient group
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Central trial contact
Pfizer CT.gov Call Center
Data sourced from clinicaltrials.gov
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