New drug trial offers hope for Hard-to-Treat cancers
NCT ID NCT05571839
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This early-stage study tests a new drug, PF-08046049/SGN-BB228, in people with advanced melanoma and other solid tumors that have spread or stopped responding to standard treatments. The main goal is to check the drug's safety and find the best dose. About 41 participants will take part in three phases to see if the drug can help control these cancers.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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41 people
The number who actually took part.
- Started
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Jan 2023
- Finished
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Jun 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ambulatory Care Center at NYU Langone Medical Center
New York, New York, 10016, United States
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BWH
Boston, Massachusetts, 02115, United States
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Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
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Clinical Research Center Dermatology (CRCD) Dermatoonkologie Charité - Universitätsmedizin Berlin
Berlin, 10115, Germany
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Clinical Research Center Dermatology (CRCD) Dermatoonkologie Charité - Universitätsmedizin Berlin
Berlin, 10117, Germany
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Dana-Farber Cancer Institute (DFCI)
Boston, Massachusetts, 02215, United States
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Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
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Insitut Gustave Roussy
Villejuif, Cedex, 94805, France
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Insitut Gustave Roussy
Villejuif, 94805, France
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Institut Gustave Roussy
Villejuif, 94805, France
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Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
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Laboratory Corporation of America
Raritan, New Jersey, 08869, United States
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Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016, United States
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NYU Langone Hospitals, NYU Langone Rusk Ambulatory Surgical Pharmacy
New York, New York, 10016, United States
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NYU Langone Medical Center(Tisch Hospital)
New York, New York, 10016, United States
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Northwestern Medical Group
Chicago, Illinois, 60611, United States
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Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
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Presbyterian/St. Lukes Medical Center
Denver, Colorado, 80218, United States
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Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
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Quest Diagnostics Incorporated - Denver
Denver, Colorado, 80209, United States
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Ronald Reagan UCLA Medical Center, Drug Information Center
Los Angeles, California, 90095, United States
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Texas Oncology - Baylor Sammons Cancer Center
Dallas, Texas, 75251, United States
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Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
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The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate
Los Angeles, California, 90025, United States
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The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate (Emergency Back-up only)
Santa Monica, California, 90404, United States
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The Beatson West of Scotland Cancer Centre
Glasgow, Glasglow CITY, G12 0YN, United Kingdom
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The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
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UCLA Hematology - Oncology Clinic - Westlake Village
Westlake Village, California, 91361, United States
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UCLA Hematology/ Oncology- Pasadena
Pasadena, California, 91105, United States
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UCLA Hematology/Oncology
Los Angeles, California, 90095, United States
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UCLA Hematology/Oncology - Administrative Office
Los Angeles, California, 90024, United States
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UCLA Hematology/Oncology - Santa Barbara
Santa Barbara, California, 93101, United States
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UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143, United States
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UCSF Medical Center, Investigational Pharmacy
San Francisco, California, 94158, United States
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US Oncology Investigational Products Center (IPC)
Irving, Texas, 75063, United States
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University of Washington Medical Center
Seattle, Washington, 98195, United States
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UniversitätsSpital Zürich Dermatologische Klinik
Zurich, CH-8091, Switzerland
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