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

• Status: Not yet recruiting
• Trial end date: 2028-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seagen Inc.

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 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

• 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 declined 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.

• 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