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Clinical Trial Finder

Search Results

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.

Los Angeles 5368361, California 5332921

Status

Address

UCLA Hematology/Oncology - Administrative Office

Los Angeles 5368361, California 5332921, 90024

Cedars-Sinai Medical Center, Los Angeles 5368361, California 5332921

Status

Address

Cedars-Sinai Medical Center

Los Angeles 5368361, California 5332921, 90048

Los Angeles 5368361, California 5332921

Status

Address

Ronald Reagan UCLA Medical Center, Drug Information Center

Los Angeles 5368361, California 5332921, 90095

UCLA Hematology/Oncology, Los Angeles 5368361, California 5332921

Status

Address

UCLA Hematology/Oncology

Los Angeles 5368361, California 5332921, 90095

San Francisco 5391959, California 5332921

Status

Address

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco 5391959, California 5332921, 94143

San Francisco 5391959, California 5332921

Status

Address

UCSF Medical Center, Investigational Pharmacy

San Francisco 5391959, California 5332921, 94158

Santa Monica 5393212, California 5332921

Status

Address

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

Santa Monica 5393212, California 5332921, 90404

Quest Diagnostics Incorporated - Denver, Denver 5419384, Colorado 5417618

Status

Address

Quest Diagnostics Incorporated - Denver

Denver 5419384, Colorado 5417618, 80209

Presbyterian/St. Lukes Medical Center, Denver 5419384, Colorado 5417618

Status

Address

Presbyterian/St. Lukes Medical Center

Denver 5419384, Colorado 5417618, 80218

Northwestern Medical Group, Chicago 4887398, Illinois 4896861

Status

Address

Northwestern Medical Group

Chicago 4887398, Illinois 4896861, 60611

Northwestern Memorial Hospital, Chicago 4887398, Illinois 4896861

Status

Address

Northwestern Memorial Hospital

Chicago 4887398, Illinois 4896861, 60611

BWH, Boston 4930956, Massachusetts 6254926

Status

Address

BWH

Boston 4930956, Massachusetts 6254926, 02115

Dana-Farber Cancer Institute (DFCI), Boston 4930956, Massachusetts 6254926

Status

Address

Dana-Farber Cancer Institute (DFCI)

Boston 4930956, Massachusetts 6254926, 02215

Laboratory Corporation of America, Raritan 5103116, New Jersey 5101760

Status

Address

Laboratory Corporation of America

Raritan 5103116, New Jersey 5101760, 08869

New York 5128581, New York 5128638

Status

Address

NYU Langone Hospitals, NYU Langone Rusk Ambulatory Surgical Pharmacy

New York 5128581, New York 5128638, 10016

New York 5128581, New York 5128638

Status

Address

NYU Langone Medical Center(Tisch Hospital)

New York 5128581, New York 5128638, 10016

Dallas 4684888, Texas 4736286

Status

Address

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas 4684888, Texas 4736286, 75246

Dallas 4684888, Texas 4736286

Status

Address

Texas Oncology - Baylor Sammons Cancer Center

Dallas 4684888, Texas 4736286, 75251

Irving 4700168, Texas 4736286

Status

Address

US Oncology Investigational Products Center (IPC)

Irving 4700168, Texas 4736286, 75063

Fred Hutchinson Cancer Center, Seattle 5809844, Washington 5815135

Status

Address

Fred Hutchinson Cancer Center

Seattle 5809844, Washington 5815135, 98109

University of Washington Medical Center, Seattle 5809844, Washington 5815135

Status

Address

University of Washington Medical Center

Seattle 5809844, Washington 5815135, 98195

International Sites

The Ottawa Hospital Cancer Centre, Ottawa 6094817, Ontario 6093943, Canada

Status

Address

The Ottawa Hospital Cancer Centre

Ottawa 6094817, Ontario 6093943, K1H 8L6

Princess Margaret Cancer Centre, Toronto 6167865, Ontario 6093943, Canada

Status

Address

Princess Margaret Cancer Centre

Toronto 6167865, Ontario 6093943, M5G 2M9

Jewish General Hospital, Montreal 6077243, Quebec 6115047, Canada

Status

Address

Jewish General Hospital

Montreal 6077243, Quebec 6115047, H3T 1E2

Insitut Gustave Roussy, Villejuif 2968705, Cedex, France

Status

Address

Insitut Gustave Roussy

Villejuif 2968705, Cedex, 94805

Institut Gustave Roussy, Villejuif 2968705, France

Status

Address

Institut Gustave Roussy

Villejuif 2968705, , 94805

Berlin 2950159, Germany

Status

Address

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

Berlin 2950159, , 10115

Berlin 2950159, Germany

Status

Address

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

Berlin 2950159, , 10117

Zurich 2657896, Switzerland

Status

Address

UniversitätsSpital Zürich Dermatologische Klinik

Zurich 2657896, , CH-8091

Glasgow 2648579, Glasglow CITY, United Kingdom

Status

Address

The Beatson West of Scotland Cancer Centre

Glasgow 2648579, Glasglow CITY, G12 0YN

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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