Melanoma Clinical Trial

A Study of SGN-BB228 in Advanced Melanoma and Other Solid Tumors

Summary

This study will test the safety of a drug called 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 SGN-BB228 should be given to participants. Part C will use the information from Parts A and B to see if SGN-BB228 is safe and if it works to treat solid tumor cancers.

View Eligibility Criteria

Eligibility Criteria

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 leptomeningeal disease. Participants with previously treated brain metastases may participate provided they are:

clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment,
they have no new or enlarging brain metastases,
and are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug.
Prior therapies cannot include any drugs targeting CD228 or 4-1BB
Immunotherapy, biologics, and/or other approved or investigational antitumor treatment that is not completed 4 weeks prior to first dose of study drug, or within 2 weeks prior to the first dose of study drug if the underlying disease has progressed on treatment

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

275

Study ID:

NCT05571839

Recruitment Status:

Recruiting

Sponsor:

Seagen Inc.

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There are 18 Locations for this study

See Locations Near You

University of California Los Angeles Medical Center
Los Angeles California, 90095, United States More Info
Fady Bertan
Contact
310-794-3879
[email protected]
Antoni Ribas
Principal Investigator
University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
San Francisco California, 94158, United States More Info
Adil Daud, MD
Principal Investigator
Sarah Cannon Research Institute at HealthONE - Denver
Denver Colorado, 80218, United States More Info
Jason Henry
Principal Investigator
Northwestern University
Chicago Illinois, 60611, United States More Info
Werhawet Gebremeskel
Contact
312-695-0387
[email protected]
Sunandana Chandra
Principal Investigator
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States More Info
Jussara Hagen
Contact
319-353-5070
[email protected]
Mohammed M Milhem
Principal Investigator
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Nicholas Critch
Contact
617-724-1268
[email protected]
Kamaneh Montazeri
Principal Investigator
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Stephen Hodi
Principal Investigator
NYU Langone Hospital
New York New York, 10016, United States More Info
Shirly Gholian
Contact
212-731-6262
Janice Mehnert
Principal Investigator
Duke University Medical Center
Durham North Carolina, 27710, United States More Info
April Salama
Principal Investigator
Texas Oncology - Baylor Sammons Cancer Center
Dallas Texas, 75251, United States More Info
Charles Cowey
Principal Investigator
Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington
Seattle Washington, 98109, United States More Info
Katie Viray
Contact
206-606-7219
[email protected]
Lisa Tachiki, MD
Principal Investigator
Ottawa Hospital Cancer Centre
Ottawa Ontario, K1H 8, Canada More Info
Arif Awan
Principal Investigator
University Health Network, Princess Margaret Hospital
Toronto Other, M5G 2, Canada More Info
Samuel Saibil
Principal Investigator
Jewish General Hospital
Montreal Quebec, H3T 1, Canada More Info
Wilson H. Miller
Principal Investigator
Institut Gustave Roussy
Villejuif Cedex Other, 94805, France More Info
Caroline Robert
Principal Investigator
Charite Universitatsmedizin Berlin
Berlin Other, 10117, Germany More Info
Thomas Eigentler
Principal Investigator
Universitatsspital Zurich
Zurich Other, 8091, Switzerland More Info
Reinhard Dummer
Principal Investigator
NHS Greater Glasgow and Clyde (NHSGGC) - The Beatson West of Scotland Cancer Centre
Glasgow Other, G12 0, United Kingdom More Info
Jeff Evans
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

275

Study ID:

NCT05571839

Recruitment Status:

Recruiting

Sponsor:


Seagen Inc.

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