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Active (not recruiting) Phase 1 NCT05571839

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

Phase 1 – testing safety in a small group of people
Conditions: Cutaneous Melanoma Non-small Cell Lung Cancer Colorectal Neoplasms Pancreatic Neoplasms Mesothelioma

Sponsor: Seagen, a wholly owned subsidiary of Pfizer

trial.available_in: БГ
Overview
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.
Who can participate
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
Interventions
PF-08046049
DRUG
Locations 36
Canada (3)
Jewish General Hospital
Montreal , Quebec
The Ottawa Hospital Cancer Centre
Ottawa , Ontario
Princess Margaret Cancer Centre
Toronto , Ontario
France (2)
Insitut Gustave Roussy
Villejuif , Cedex
Institut Gustave Roussy
Villejuif
Germany (2)
Clinical Research Center Dermatology (CRCD) Dermatoonkologie Charité - Universitätsmedizin Berlin
Berlin
Clinical Research Center Dermatology (CRCD) Dermatoonkologie Charité - Universitätsmedizin Berlin
Berlin
Switzerland (1)
UniversitätsSpital Zürich Dermatologische Klinik
Zurich
United Kingdom (1)
The Beatson West of Scotland Cancer Centre
Glasgow , Glasglow CITY
United States (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
Westlake Village , California
Technical details
Status
Active (not recruiting)
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
03.01.2023
Completion date
06.06.2026
Registry ID
NCT05571839
Source
clinicaltrials.gov
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