C5901001 - Adults With Advanced Melanoma and Other Solid Tumours
Research type
Research Study
Full title
AN OPEN-LABEL PHASE 1 STUDY TO INVESTIGATE PF-08046031 IN ADULTS WITH ADVANCED MELANOMA AND OTHER SOLID TUMORS.
IRAS ID
1011169
Contact name
Tun Tun Lin
Contact email
Sponsor organisation
Pfizer Inc.
Clinicaltrials.gov Identifier
Research summary
This is a clinical study to explore the safety and response to the study drug (PF-08046031), which is a type of drug called an antibody-drug conjugate (ADC). The antibody part of the study drug is designed to bind to cancer cells so that the drug part can kill them. This study will look at different doses and/or schedule of the study drug given into the vein and learn about how the drug is tolerated at each dose level and/or schedule. This study will include patients with melanoma (a type of skin cancer), or who have a type of lung cancer, or certain cancers that started in the mouth, throat or voice box or gullet.
Participation in this study is voluntary and different from usual medical care. The study doctor will determine eligibility of participants who will need to visit the study site either every one or two weeks to receive the study drug and for study assessments. Study procedures will include collecting information about participants’ health status and side effects, performing blood and urine tests, body scans such as CT and/or MRI to assess tumours, and collecting existing or new biopsies if applicable. Participants may need to visit the study site more frequently if needed.
During this study, there may be risks or discomforts that are common, rare, and/or unknown at this time as this is the first study with PF-08046031 in humans. The study doctor will explain potential risks and discomforts. A participant may change his/her mind later at any time without losing any benefits or medical care to which he/she is entitled. It is possible that a participant’s health may improve, worsen, or stay the same in this study. Although there is no guarantee about a benefit to the participants, it may benefit future patients.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
25/NE/0062
Date of REC Opinion
20 May 2025
REC opinion
Further Information Favourable Opinion