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New drug trial offers hope for Hard-to-Treat cancers

NCT ID NCT05571839

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

41 people

The number who actually took part.

Started

Jan 2023

Finished

Jun 2026

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Ambulatory Care Center at NYU Langone Medical Center

    New York, New York, 10016, United States

  • BWH

    Boston, Massachusetts, 02115, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

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

    Berlin, 10115, Germany

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

    Berlin, 10117, Germany

  • Dana-Farber Cancer Institute (DFCI)

    Boston, Massachusetts, 02215, United States

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • Insitut Gustave Roussy

    Villejuif, Cedex, 94805, France

  • Insitut Gustave Roussy

    Villejuif, 94805, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • Laboratory Corporation of America

    Raritan, New Jersey, 08869, United States

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016, United States

  • NYU Langone Hospitals, NYU Langone Rusk Ambulatory Surgical Pharmacy

    New York, New York, 10016, United States

  • NYU Langone Medical Center(Tisch Hospital)

    New York, New York, 10016, United States

  • Northwestern Medical Group

    Chicago, Illinois, 60611, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Presbyterian/St. Lukes Medical Center

    Denver, Colorado, 80218, United States

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Quest Diagnostics Incorporated - Denver

    Denver, Colorado, 80209, United States

  • Ronald Reagan UCLA Medical Center, Drug Information Center

    Los Angeles, California, 90095, United States

  • Texas Oncology - Baylor Sammons Cancer Center

    Dallas, Texas, 75251, United States

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246, United States

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

    Los Angeles, California, 90025, United States

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

    Santa Monica, California, 90404, United States

  • The Beatson West of Scotland Cancer Centre

    Glasgow, Glasglow CITY, G12 0YN, United Kingdom

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6, Canada

  • UCLA Hematology - Oncology Clinic - Westlake Village

    Westlake Village, California, 91361, United States

  • UCLA Hematology/ Oncology- Pasadena

    Pasadena, California, 91105, United States

  • UCLA Hematology/Oncology

    Los Angeles, California, 90095, United States

  • UCLA Hematology/Oncology - Administrative Office

    Los Angeles, California, 90024, United States

  • UCLA Hematology/Oncology - Santa Barbara

    Santa Barbara, California, 93101, United States

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94143, United States

  • UCSF Medical Center, Investigational Pharmacy

    San Francisco, California, 94158, United States

  • US Oncology Investigational Products Center (IPC)

    Irving, Texas, 75063, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • UniversitätsSpital Zürich Dermatologische Klinik

    Zurich, CH-8091, Switzerland

More trials for these conditions

Other studies related to the condition(s) this trial covers.