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

Last updated: April 17, 2026
Sponsor: Seagen, a wholly owned subsidiary of Pfizer
Overall Status: Active - Not Recruiting

Phase

1

Condition

Malignant Melanoma

Digestive System Neoplasms

Non-small Cell Lung Cancer

Treatment

SGN-BB228

PF-08046049

Clinical Study ID

NCT05571839
SGNBB228-001
2022-502348-11-00
C5871001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All Parts: Participants must have disease that is relapsed, refractory, orintolerant to standard of care. Participants must have histologically orcytologically confirmed metastatic malignancy.

  • Participants must have one of the following tumor types:

  • Parts A and B: Participants must have metastatic or unresectable cutaneousmelanoma.

  • 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 othertherapies.

  • Participants with a targetable BRAF mutation must have been treated with, beenintolerant of, or been deemed ineligible to receive treatment with BRAF/MEKtargeted 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

Exclusion Criteria:

  • History of another malignancy within 3 years before the first dose of study drug, orany evidence of residual disease from a previously diagnosed malignancy. Exceptionsare malignancies with a negligible risk of metastasis or death.

  • Active central nervous system metastases or leptomeningeal disease. Participantswith previously treated brain metastases may participate provided they are:

  • clinically stable for at least 4 weeks prior to study entry after brainmetastasis treatment,

  • they have no new or enlarging brain metastases,

  • and are off of corticosteroids prescribed for symptoms associated with brainmetastases 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 antitumortreatment 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 hasprogressed on treatment

  • Melanoma subtypes including acral, uveal, and mucosal are excluded

Study Design

Total Participants: 41
Treatment Group(s): 2
Primary Treatment: SGN-BB228
Phase: 1
Study Start date:
January 03, 2023
Estimated Completion Date:
June 06, 2026

Connect with a study center

  • Ottawa Hospital Cancer Centre

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • University of Ottawa / Ottawa General Hospital

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • University Health Network, Princess Margaret Hospital

    Toronto, Ontario M5G 2C1
    Canada

    Site Not Available

  • The Ottawa Hospital Cancer Centre

    Ottawa 6094817, Ontario 6093943 K1H 8L6
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto 6167865, Ontario 6093943 M5G 2M9
    Canada

    Site Not Available

  • Jewish General Hospital

    Montreal, Quebec H3T 1E2
    Canada

    Site Not Available

  • Jewish General Hospital

    Montreal 6077243, Quebec 6115047 H3T 1E2
    Canada

    Site Not Available

  • Insitut Gustave Roussy

    Villejuif, Cedex 94805
    France

    Site Not Available

  • Insitut Gustave Roussy

    Villejuif 2968705, Cedex 94805
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif, 94805
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif 2968705, 94805
    France

    Site Not Available

  • Insitut Gustave Roussy

    Villejuif Cedex, 94805
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif Cedex, 94805
    France

    Site Not Available

  • Charite Universitatsmedizin Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • Clinical Research Center Dermatology (CRCD) Dermatoonkologie Charité - Universitätsmedizin Berlin

    Berlin, 10115
    Germany

    Site Not Available

  • Labor Berlin - Charite Vivantes GmbH

    Berlin, 13353
    Germany

    Active - Recruiting

  • Clinical Research Center Dermatology (CRCD) Dermatoonkologie Charité - Universitätsmedizin Berlin

    Berlin 2950159, 10117
    Germany

    Site Not Available

  • Universitatsspital Zurich

    Zurich, 8091
    Switzerland

    Site Not Available

  • UniversitätsSpital Zürich Dermatologische Klinik

    Zurich, CH-8091
    Switzerland

    Site Not Available

  • UniversitätsSpital Zürich Dermatologische Klinik

    Zurich 2657896, CH-8091
    Switzerland

    Site Not Available

  • UniversitätsSpital Zürich Dermatologische Klinik

    Zürich, CH-8091
    Switzerland

    Site Not Available

  • The Beatson West of Scotland Cancer Centre

    Glasglow, Glasglow CITY G12 0YH
    United Kingdom

    Site Not Available

  • The Beatson West of Scotland Cancer Centre

    Glasgow, Glasglow CITY G12 0YN
    United Kingdom

    Site Not Available

  • The Beatson West of Scotland Cancer Centre

    Glasgow 2648579, Glasglow CITY G12 0YN
    United Kingdom

    Site Not Available

  • NHS Greater Glasgow and Clyde (NHSGGC) - The Beatson West of Scotland Cancer Centre

    Glasgow, Other G12 0Yn
    United Kingdom

    Active - Recruiting

  • The Beatson WOS Cancer Centre

    Glasgow, G12 0YN
    United Kingdom

    Active - Recruiting

  • Mayo Clinic Arizona

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Mayo Clinic Building - Phoenix

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Ronald Reagan UCLA Medical Center, Drug Information Center

    Los Angeles, California 90095
    United States

    Site Not Available

  • The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate

    Los Angeles, California 90025
    United States

    Site Not Available

  • The Angeles Clinic and Research Institute

    Los Angeles, California 90025
    United States

    Site Not Available

  • UCLA Hematology/Oncology

    Los Angeles, California 90095
    United States

    Site Not Available

  • UCLA Hematology/Oncology - Administrative Office

    Los Angeles, California 90024
    United States

    Site Not Available

  • University of California Los Angeles Medical Center

    Los Angeles, California 90095
    United States

    Site Not Available

  • UCLA Hematology/ Oncology- Pasadena

    Pasadena, California 91105
    United States

    Site Not Available

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California 94143
    United States

    Site Not Available

  • UCSF Medical Center, Investigational Pharmacy

    San Francisco, California 94158
    United States

    Site Not Available

  • University of California at San Francisco

    San Francisco, California 94158
    United States

    Active - Recruiting

  • University of California, San Francisco | HDFCCC - Hematopoietic Malignancies

    San Francisco, California 94158
    United States

    Active - Recruiting

  • UCLA Hematology/Oncology - Santa Barbara

    Santa Barbara, California 93101
    United States

    Site Not Available

  • The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate (Emergency Back-up only)

    Santa Monica, California 90404
    United States

    Site Not Available

  • UCLA Hematology - Oncology Clinic - Westlake Village

    Westlake Village, California 91361
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles 5368361, California 5332921 90048
    United States

    Site Not Available

  • Ronald Reagan UCLA Medical Center, Drug Information Center

    Los Angeles 5368361, California 5332921 90095
    United States

    Site Not Available

  • The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate

    Los Angeles 5368361, California 5332921 90025
    United States

    Site Not Available

  • UCLA Hematology/Oncology

    Los Angeles 5368361, California 5332921 90095
    United States

    Site Not Available

  • UCLA Hematology/Oncology - Administrative Office

    Los Angeles 5368361, California 5332921 90024
    United States

    Site Not Available

  • UCLA Hematology/ Oncology- Pasadena

    Pasadena 5381396, California 5332921 91105
    United States

    Site Not Available

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco 5391959, California 5332921 94143
    United States

    Site Not Available

  • UCSF Medical Center, Investigational Pharmacy

    San Francisco 5391959, California 5332921 94158
    United States

    Site Not Available

  • UCLA Hematology/Oncology - Santa Barbara

    Santa Barbara 5392952, California 5332921 93101
    United States

    Site Not Available

  • The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate (Emergency Back-up only)

    Santa Monica 5393212, California 5332921 90404
    United States

    Site Not Available

  • UCLA Hematology - Oncology Clinic - Westlake Village

    Westlake Village 5408395, California 5332921 91361
    United States

    Site Not Available

  • Presbyterian St. Lukes Medical Center

    Denver, Colorado 80218
    United States

    Site Not Available

  • Presbyterian/St. Lukes Medical Center

    Denver, Colorado 80218
    United States

    Site Not Available

  • Quest Diagnostics Incorporated - Denver

    Denver, Colorado 80209
    United States

    Site Not Available

  • Sarah Cannon Research Institute at HealthONE - Denver

    Denver, Colorado 80218
    United States

    Site Not Available

  • Presbyterian/St. Lukes Medical Center

    Denver 5419384, Colorado 5417618 80218
    United States

    Site Not Available

  • Quest Diagnostics Incorporated - Denver

    Denver 5419384, Colorado 5417618 80209
    United States

    Site Not Available

  • Mayo Clinic Florida

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Northwestern Medical Group

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Northwestern Medical Group

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • Northwestern Memorial Hospital

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • BWH

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Brigham and Women's Hospital Clinic Lab (285)

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana-Farber Cancer Institute (DFCI)

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • BWH

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • Dana-Farber Cancer Institute (DFCI)

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic Rochester.

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Laboratory Corporation of America

    Raritan, New Jersey 08869
    United States

    Site Not Available

  • Laboratory Corporation of America

    Raritan 5103116, New Jersey 5101760 08869
    United States

    Site Not Available

  • Ambulatory Care Center at NYU Langone Medical Center

    New York, New York 10016
    United States

    Site Not Available

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • NYU Langone Hospital

    New York, New York 10016
    United States

    Active - Recruiting

  • NYU Langone Hospitals, NYU Langone Rusk Ambulatory Surgical Pharmacy

    New York, New York 10016
    United States

    Site Not Available

  • NYU Langone Medical Center(Tisch Hospital)

    New York, New York 10016
    United States

    Site Not Available

  • New York University (NYU) Cancer Institute

    New York, New York 10016
    United States

    Site Not Available

  • Ambulatory Care Center at NYU Langone Medical Center

    New York 5128581, New York 5128638 10016
    United States

    Site Not Available

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York 5128581, New York 5128638 10016
    United States

    Site Not Available

  • NYU Langone Hospitals, NYU Langone Rusk Ambulatory Surgical Pharmacy

    New York 5128581, New York 5128638 10016
    United States

    Site Not Available

  • NYU Langone Medical Center(Tisch Hospital)

    New York 5128581, New York 5128638 10016
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Texas Oncology - Baylor Sammons Cancer Center

    Dallas, Texas 75251
    United States

    Site Not Available

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas 75246
    United States

    Site Not Available

  • US Oncology Investigational Products Center (IPC)

    Irving, Texas 75063
    United States

    Site Not Available

  • Texas Oncology - Baylor Sammons Cancer Center

    Dallas 4684888, Texas 4736286 75251
    United States

    Site Not Available

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas 4684888, Texas 4736286 75246
    United States

    Site Not Available

  • US Oncology Investigational Products Center (IPC)

    Irving 4700168, Texas 4736286 75063
    United States

    Site Not Available

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Site Not Available

  • Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington

    Seattle, Washington 98109
    United States

    Site Not Available

  • Seattle Cancer Care Alliance / University of Washington

    Seattle, Washington 98109
    United States

    Active - Recruiting

  • University of Washington Medical Center

    Seattle, Washington 98195
    United States

    Site Not Available

  • Fred Hutchinson Cancer Center

    Seattle 5809844, Washington 5815135 98109
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle 5809844, Washington 5815135 98195
    United States

    Site Not Available

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