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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05571839
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Seagen, a wholly owned subsidiary of Pfizer
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Pfizer CT.gov Call Center
Principal Investigator Affiliation Pfizer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Canada, France, Germany, Switzerland, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cutaneous Melanoma, Non-small Cell Lung Cancer, Colorectal Neoplasms, Pancreatic Neoplasms, Mesothelioma
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: PF-08046049

PF-08046049 monotherapy

Interventions

Drug: - PF-08046049

Given into the vein (IV; intravenous)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic Arizona, Phoenix, Arizona

Status

Address

Mayo Clinic Arizona

Phoenix, Arizona, 85054

Mayo Clinic Building - Phoenix, Phoenix, Arizona

Status

Address

Mayo Clinic Building - Phoenix

Phoenix, Arizona, 85054

Los Angeles, California

Status

Address

UCLA Hematology/Oncology - Administrative Office

Los Angeles, California, 90024

Cedars-Sinai Medical Center, Los Angeles, California

Status

Address

Cedars-Sinai Medical Center

Los Angeles, California, 90048

Los Angeles, California

Status

Address

Ronald Reagan UCLA Medical Center, Drug Information Center

Los Angeles, California, 90095

UCLA Hematology/Oncology, Los Angeles, California

Status

Address

UCLA Hematology/Oncology

Los Angeles, California, 90095

San Francisco, California

Status

Address

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94143

San Francisco, California

Status

Address

UCSF Medical Center, Investigational Pharmacy

San Francisco, California, 94158

Santa Monica, California

Status

Address

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

Santa Monica, California, 90404

Quest Diagnostics Incorporated - Denver, Denver, Colorado

Status

Address

Quest Diagnostics Incorporated - Denver

Denver, Colorado, 80209

Presbyterian/St. Lukes Medical Center, Denver, Colorado

Status

Address

Presbyterian/St. Lukes Medical Center

Denver, Colorado, 80218

Northwestern Medical Group, Chicago, Illinois

Status

Address

Northwestern Medical Group

Chicago, Illinois, 60611

Northwestern Memorial Hospital, Chicago, Illinois

Status

Address

Northwestern Memorial Hospital

Chicago, Illinois, 60611

BWH, Boston, Massachusetts

Status

Address

BWH

Boston, Massachusetts, 02115

Dana-Farber Cancer Institute (DFCI), Boston, Massachusetts

Status

Address

Dana-Farber Cancer Institute (DFCI)

Boston, Massachusetts, 02215

Mayo Clinic Rochester., Rochester, Minnesota

Status

Address

Mayo Clinic Rochester.

Rochester, Minnesota, 55905

Laboratory Corporation of America, Raritan, New Jersey

Status

Address

Laboratory Corporation of America

Raritan, New Jersey, 08869

New York, New York

Status

Address

NYU Langone Hospitals, NYU Langone Rusk Ambulatory Surgical Pharmacy

New York, New York, 10016

New York, New York

Status

Address

NYU Langone Medical Center(Tisch Hospital)

New York, New York, 10016

Dallas, Texas

Status

Address

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246

Dallas, Texas

Status

Address

Texas Oncology - Baylor Sammons Cancer Center

Dallas, Texas, 75251

Irving, Texas

Status

Address

US Oncology Investigational Products Center (IPC)

Irving, Texas, 75063

Fred Hutchinson Cancer Center, Seattle, Washington

Status

Address

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

University of Washington Medical Center, Seattle, Washington

Status

Address

University of Washington Medical Center

Seattle, Washington, 98195

International Sites

The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada

Status

Address

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Status

Address

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9

Jewish General Hospital, Montreal, Quebec, Canada

Status

Address

Jewish General Hospital

Montreal, Quebec, H3T 1E2

Insitut Gustave Roussy, Villejuif, Cedex, France

Status

Address

Insitut Gustave Roussy

Villejuif, Cedex, 94805

Institut Gustave Roussy, Villejuif Cedex, France

Status

Address

Institut Gustave Roussy

Villejuif Cedex, , 94805

Berlin, Germany

Status

Address

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

Berlin, , 10115

Berlin, Germany

Status

Address

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

Berlin, , 10117

Zürich, Switzerland

Status

Address

UniversitätsSpital Zürich Dermatologische Klinik

Zürich, , CH-8091

Glasglow, Glasglow CITY, United Kingdom

Status

Address

The Beatson West of Scotland Cancer Centre

Glasglow, Glasglow CITY, G12 0YH

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