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Cutaneous MelanomaPhase 1NCT05571839

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

A Phase 1 study testing PF-08046049 in people with Cutaneous Melanoma and Non-small Cell Lung Cancer, run by Seagen, a wholly owned subsidiary of Pfizer at 37 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PF-08046049
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
37 sitesin 6 countries
Study dates
3 Jan 2023to 1 Jun 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 15Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

37 sites in 6 countries.

37 sites in 6 countries

United States27 sites

  • BWH

    Boston, Massachusetts, 02115

  • Dana-Farber Cancer Institute (DFCI)

    Boston, Massachusetts, 02215

  • Northwestern Medical Group

    Chicago, Illinois, 60611

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Texas Oncology - Baylor Sammons Cancer Center

    Dallas, Texas, 75251

  • Quest Diagnostics Incorporated - Denver

    Denver, Colorado, 80209

  • Presbyterian/St. Lukes Medical Center

    Denver, Colorado, 80218

  • US Oncology Investigational Products Center (IPC)

    Irving, Texas, 75063

  • UCLA Hematology/Oncology - Administrative Office

    Los Angeles, California, 90024

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

    Los Angeles, California, 90025

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Ronald Reagan UCLA Medical Center, Drug Information Center

    Los Angeles, California, 90095

  • UCLA Hematology/Oncology

    Los Angeles, California, 90095

  • Ambulatory Care Center at NYU Langone Medical Center

    New York, New York, 10016

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016

  • NYU Langone Hospitals, NYU Langone Rusk Ambulatory Surgical Pharmacy

    New York, New York, 10016

  • NYU Langone Medical Center(Tisch Hospital)

    New York, New York, 10016

  • UCLA Hematology/ Oncology- Pasadena

    Pasadena, California, 91105

  • Laboratory Corporation of America

    Raritan, New Jersey, 08869

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94143

  • UCSF Medical Center, Investigational Pharmacy

    San Francisco, California, 94158

  • UCLA Hematology/Oncology - Santa Barbara

    Santa Barbara, California, 93101

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

    Santa Monica, California, 90404

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • UCLA Hematology - Oncology Clinic - Westlake Village

    Westlake Village, California, 91361

Other trials in United States

Canada3 sites

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

France3 sites

  • Insitut Gustave Roussy

    Villejuif, Cedex, 94805

  • Insitut Gustave Roussy

    Villejuif, 94805

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Germany2 sites

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

    Berlin, 10115

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

    Berlin, 10117

Other trials in Germany

Switzerland1 site

  • UniversitätsSpital Zürich Dermatologische Klinik

    Zurich, CH-8091

Other trials in Switzerland

United Kingdom1 site

  • The Beatson West of Scotland Cancer Centre

    Glasgow, Glasglow CITY, G12 0YN

Other trials in United Kingdom

About this study

Official title: A Phase 1 Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors

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.

Being tested
PF-08046049
Keywords
NSCLC, Colorectal Cancer, CRC, Pancreatic Cancer
Medical subject headings
Melanoma, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Pancreatic Neoplasms, Mesothelioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-08046049Drug

    Given into the vein (IV; intravenous)

Study groups in NCT05571839
Study groupRoleWhat they receive
PF-08046049ExperimentalPF-08046049 monotherapy
Receives: Drug: PF-08046049

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events (AEs)

    Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

    Measured: Through 30 days after the last study treatment; approximately 7 months

  2. Number of participants with laboratory abnormalities

    Measured: Through 30 days after the last study treatment; approximately 7 months

  3. Number of participants with dose limiting toxicities

    Measured: Up to 28 days

Secondary outcomes (10)

  1. Number of participants with antidrug antibodies

    To be summarized using descriptive statistics

    Measured: Through 30 days after the last study treatment; approximately 7 months

  2. Pharmacokinetic (PK) parameter - Area under the curve (AUC)

    To be summarized using descriptive statistics

    Measured: Through 30 days after the last study treatment; approximately 7 months

  3. PK parameter - Maximum Concentration (Cmax)

    To be summarized using descriptive statistics

    Measured: Through 30 days after the last study treatment; approximately 7 months

  4. PK parameter - Time to maximum concentration (Tmax)

    To be summarized using descriptive statistics

    Measured: Through 30 days after the last study treatment; approximately 7 months

  5. PK parameter - Apparent terminal half-life (t1/2)

    To be summarized using descriptive statistics

    Measured: Through 30 days after the last study treatment; approximately 7 months

  6. PK parameter - Trough concentration (Ctrough)

    To be summarized using descriptive statistics

    Measured: Through 30 days after the last study treatment; approximately 7 months

  7. Objective response rate (ORR)

    The proportion of participants with a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by the investigator

    Measured: Up to approximately 1 year

  8. Duration of response (DOR)

    The time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of progressive disease (PD) (based on radiographic assessments per RECIST v1.1) or death due to any cause

    Measured: Up to approximately 1 year

  9. Progression-free survival (PFS)

    The time from the start of study treatment to the first documentation of PD (per RECIST v1.1 as assessed by the investigator) or death due to any cause

    Measured: Up to approximately 1 year

  10. Overall survival (OS)

    The time from the start of study treatment to death due to any cause

    Measured: Approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2022
  2. Study start3 Jan 2023
  3. Primary completion1 Jun 2026
  4. Study completion1 Jun 2026

Why it stopped: The trial was terminated for strategic reasons. The decision was not based on any safety concerns.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05571839
Sponsor's protocol ID
SGNBB228-001
Other IDs
C5871001, 2022-502348-11-00
Status last verified
Jun 2026
First submitted
5 Oct 2022
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-08046049 in people with Cutaneous Melanoma and Non-small Cell Lung Cancer, run by Seagen, a wholly owned subsidiary of Pfizer at 37 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Canada, France, Germany, Switzerland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The trial was terminated for strategic reasons. The decision was not based on any safety concerns.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (AEs) (time frame: Through 30 days after the last study treatment; approximately 7 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05571839.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

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