A Phase I Study of SGN-BB228 in Patients with Advanced Melanoma and Other Solid Tumors
Summary description of the study
We are studying SGN-BB228 to find out what side effects it has and whether it works for certain types of cancer. We also want to find out if SGN-BB228 is effective in treating certain cancers and learn more about the best dose. This study is conducted in three parts. In Part A of the study, we examine SGN-BB228 to find the best dose. In Part B of the study, we may use the information obtained in Part A to continue studying the best dose and schedule for SGN-BB228. In Part C of the study, we use what we have learned about the best dose and schedule to investigate how SGN-BB228 works in the treatment of skin cancer and some other cancers.
(BASEC)
Intervention under investigation
The investigational drug will be administered over a period referred to as a "cycle".
• Part A: SGN-BB228 is administered intravenously (i.v.) on Days 1 and 15 of each 4-week cycle.
• Part B: We may administer SGN-BB228 i.v. according to one of the following schedules:
o On Days 1, 8, and 15 of each 3-week cycle.
o On Day 1 of each 3-week cycle.
We may also investigate other dosing regimens in Parts A and B of the study.
Part C: We may administer SGN-BB228 according to one of the above schedules every 3 or 4 weeks.
(BASEC)
Disease under investigation
• Melanoma • Lung cancer • Colorectal cancer • Pancreatic cancer • Mesothelioma
(BASEC)
1. Participants who are at least 18 years old. 2. Participants with a confirmed metastatic or inoperable cutaneous melanoma. 3. Participants with one of the following histologically or cytologically confirmed metastatic or inoperable solid malignancies within one of the tumor types listed below: • Melanoma • Lung cancer • Colorectal cancer • Pancreatic cancer • Mesothelioma (BASEC)
Exclusion criteria
1. History of another malignancy within 3 years prior to the first dose of the study drug or evidence of residual disease from a previously diagnosed malignancy. 2. Known active metastases of the central nervous system 3. Any active viral, bacterial, or fungal infection within 2 weeks prior to the first dose of the study drug. (BASEC)
Trial sites
Zurich
(BASEC)
Sponsor
Seagen Inc., (A wholly owned subsidiary of Pfizer Inc.), 21823 30th Drive SE, Bothell, WA 98021, United States
(BASEC)
Contact
Contact Person Switzerland
Dr.med.Dr.sc.med Egle Ramelyte
+41 44 255 11 11
Egle.Ramelyte@clutterusz.chUniversitätsspital Zürich
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
30.05.2023
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
A phase 1 study of PF-08046049/SGN-BB228 in advanced melanoma and other solid tumors (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
not available
Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
not available