Open
Actively Recruiting
A Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors
About
Brief 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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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
- Melanoma subtypes including acral, uveal, and mucosal are excluded
Join this Trial
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Study Stats
Protocol No.
23-000935
Category
Colorectal Cancer
Lung Cancer
Melanoma (Skin Cancer)
Pancreatic Cancer
Principal Investigator
Contact
Location
- UCLA Pasadena
- UCLA Santa Barbara
- UCLA Westlake Village
- UCLA Westwood