A Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors (NCT05571839) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors
United States, Canada, France41 participantsStarted 2023-01-03
Plain-language summary
This study will test the safety of a drug called PF-08046049/SGN-BB228 in participants with melanoma and other solid tumors that are hard to treat 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.
This study will have 3 parts. Parts A and B of the study will find out how much PF-08046049/SGN-BB228 should be given to participants. Part C will use the information from Parts A and B to see if PF-08046049/SGN-BB228 is safe and if it works to treat solid tumor cancers.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All Parts: Participants must have disease that is relapsed, refractory, or intolerant to standard of care. Participants must have histologically or cytologically confirmed metastatic malignancy.
* Participants must have one of the following tumor types:
* Parts A and B: Participants must have metastatic or unresectable cutaneous melanoma.
* Part C: Participants must have one of the following tumor types:
* Cutaneous Melanoma
* Non-small Cell Lung Cancer (NSCLC)
* Colorectal Cancer (CRC)
* Pancreatic Cancer
* Mesothelioma
* A pre-treatment biopsy or submission of archival tissue is required
* For participants with cutaneous melanoma
* Must have been previously treated with an anti-programmed death-1 (anti-PD-1) or anti-programmed death ligand-1 (anti-PD-L1) agent given alone or with other therapies.
* Participants with a targetable BRAF mutation must have been treated with, been intolerant of, or been deemed ineligible to receive treatment with BRAF/MEK targeted therapy prior to study entry.
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
* Measurable disease per RECIST v1.1 at baseline
Exclusion Criteria:
* History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
* Active central nervous system metastases or leptomeni…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with adverse events (AEs)
Timeframe: Through 30 days after the last study treatment; approximately 7 months
2
Number of participants with laboratory abnormalities
Timeframe: Through 30 days after the last study treatment; approximately 7 months
3
Number of participants with dose limiting toxicities
Timeframe: Up to 28 days
Trial details
NCT IDNCT05571839
SponsorSeagen, a wholly owned subsidiary of Pfizer