Спонсор: Seagen, a wholly owned subsidiary of Pfizer
Налично на:
БГ
Обобщение
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.
Кой може да участва
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
Интервенции
PF-08046049
DRUG
Места на провеждане
36
Канада (3)
Jewish General Hospital
Montreal , Quebec
The Ottawa Hospital Cancer Centre
Ottawa , Ontario
Princess Margaret Cancer Centre
Toronto , Ontario
Франция (2)
Insitut Gustave Roussy
Villejuif , Cedex
Institut Gustave Roussy
Villejuif
Германия (2)
Clinical Research Center Dermatology (CRCD) Dermatoonkologie Charité - Universitätsmedizin Berlin
Berlin
Clinical Research Center Dermatology (CRCD) Dermatoonkologie Charité - Universitätsmedizin Berlin
Berlin
Швейцария (1)
UniversitätsSpital Zürich Dermatologische Klinik
Zurich
Великобритания (1)
The Beatson West of Scotland Cancer Centre
Glasgow , Glasglow CITY
САЩ (27)
BWH
Boston , Massachusetts
Dana-Farber Cancer Institute (DFCI)
Boston , Massachusetts
Northwestern Medical Group
Chicago , Illinois
Northwestern Memorial Hospital
Chicago , Illinois
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas , Texas
Texas Oncology - Baylor Sammons Cancer Center
Dallas , Texas
Quest Diagnostics Incorporated - Denver
Denver , Colorado
Presbyterian/St. Lukes Medical Center
Denver , Colorado
US Oncology Investigational Products Center (IPC)
Irving , Texas
UCLA Hematology/Oncology - Administrative Office
Los Angeles , California
The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate
Los Angeles , California
Cedars-Sinai Medical Center
Los Angeles , California
Ronald Reagan UCLA Medical Center, Drug Information Center
Los Angeles , California
UCLA Hematology/Oncology
Los Angeles , California
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York , New York
NYU Langone Hospitals, NYU Langone Rusk Ambulatory Surgical Pharmacy
New York , New York
NYU Langone Medical Center(Tisch Hospital)
New York , New York
Ambulatory Care Center at NYU Langone Medical Center
New York , New York
UCLA Hematology/ Oncology- Pasadena
Pasadena , California
Laboratory Corporation of America
Raritan , New Jersey
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco , California
UCSF Medical Center, Investigational Pharmacy
San Francisco , California
UCLA Hematology/Oncology - Santa Barbara
Santa Barbara , California
The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate (Emergency Back-up only)
Santa Monica , California
Fred Hutchinson Cancer Center
Seattle , Washington
University of Washington Medical Center
Seattle , Washington
UCLA Hematology - Oncology Clinic - Westlake Village