A Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors

Stopped early · Phase 1

Conditions studied: Cutaneous Melanoma, Non-small Cell Lung Cancer, Colorectal Neoplasms, Pancreatic Neoplasms, Mesothelioma

In brief

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.

Key facts

Study ID

NCT05571839

Run by

Seagen, a wholly owned subsidiary of Pfizer

People needed

41

Starts

2023-01-03

Expected to finish

2026-06-01

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCSF Medical Center, Investigational Pharmacy — San Francisco, California, United States
• UCLA Hematology/Oncology - Administrative Office — Los Angeles, California, United States
• The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center, Drug Information Center — Los Angeles, California, United States
• UCLA Hematology/Oncology — Los Angeles, California, United States
• UCLA Hematology/ Oncology- Pasadena — Pasadena, California, United States
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• UCLA Hematology/Oncology - Santa Barbara — Santa Barbara, California, United States
• The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate (Emergency Back-up only) — Santa Monica, California, United States
• UCLA Hematology - Oncology Clinic - Westlake Village — Westlake Village, California, United States
• Quest Diagnostics Incorporated - Denver — Denver, Colorado, United States
• Presbyterian/St. Lukes Medical Center — Denver, Colorado, United States
• Northwestern Medical Group — Chicago, Illinois, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• BWH — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute (DFCI) — Boston, Massachusetts, United States
• Laboratory Corporation of America — Raritan, New Jersey, United States
• Ambulatory Care Center at NYU Langone Medical Center — New York, New York, United States
• Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York, United States
• NYU Langone Hospitals, NYU Langone Rusk Ambulatory Surgical Pharmacy — New York, New York, United States
• NYU Langone Medical Center(Tisch Hospital) — New York, New York, United States
• Texas Oncology-Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States
• Texas Oncology - Baylor Sammons Cancer Center — Dallas, Texas, United States
• US Oncology Investigational Products Center (IPC) — Irving, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.