A Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors
Purpose
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.
Conditions
- Cutaneous Melanoma
- Non-small Cell Lung Cancer
- Colorectal Neoplasms
- Pancreatic Neoplasms
- Mesothelioma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental PF-08046049 |
PF-08046049 monotherapy |
|
Recruiting Locations
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Seagen Inc.