A Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors
A Phase 1 Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors
3 other identifiers
interventional
41
6 countries
36
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2023
Typical duration for phase_1
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2022
CompletedFirst Posted
Study publicly available on registry
October 7, 2022
CompletedStudy Start
First participant enrolled
January 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 6, 2026
April 20, 2026
April 1, 2026
3.4 years
October 5, 2022
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
Through 30 days after the last study treatment; approximately 7 months
Number of participants with laboratory abnormalities
Through 30 days after the last study treatment; approximately 7 months
Number of participants with dose limiting toxicities
Up to 28 days
Secondary Outcomes (10)
Number of participants with antidrug antibodies
Through 30 days after the last study treatment; approximately 7 months
Pharmacokinetic (PK) parameter - Area under the curve (AUC)
Through 30 days after the last study treatment; approximately 7 months
PK parameter - Maximum Concentration (Cmax)
Through 30 days after the last study treatment; approximately 7 months
PK parameter - Time to maximum concentration (Tmax)
Through 30 days after the last study treatment; approximately 7 months
PK parameter - Apparent terminal half-life (t1/2)
Through 30 days after the last study treatment; approximately 7 months
- +5 more secondary outcomes
Study Arms (1)
PF-08046049
EXPERIMENTALPF-08046049 monotherapy
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
UCLA Hematology/Oncology - Administrative Office
Los Angeles, California, 90024, United States
The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate
Los Angeles, California, 90025, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Ronald Reagan UCLA Medical Center, Drug Information Center
Los Angeles, California, 90095, United States
UCLA Hematology/Oncology
Los Angeles, California, 90095, United States
UCLA Hematology/ Oncology- Pasadena
Pasadena, California, 91105, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143, United States
UCSF Medical Center, Investigational Pharmacy
San Francisco, California, 94158, United States
UCLA Hematology/Oncology - Santa Barbara
Santa Barbara, California, 93101, United States
The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate (Emergency Back-up only)
Santa Monica, California, 90404, United States
UCLA Hematology - Oncology Clinic - Westlake Village
Westlake Village, California, 91361, United States
Quest Diagnostics Incorporated - Denver
Denver, Colorado, 80209, United States
Presbyterian/St. Lukes Medical Center
Denver, Colorado, 80218, United States
Northwestern Medical Group
Chicago, Illinois, 60611, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
BWH
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute (DFCI)
Boston, Massachusetts, 02215, United States
Laboratory Corporation of America
Raritan, New Jersey, 08869, United States
Ambulatory Care Center at NYU Langone Medical Center
New York, New York, 10016, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016, United States
NYU Langone Hospitals, NYU Langone Rusk Ambulatory Surgical Pharmacy
New York, New York, 10016, United States
NYU Langone Medical Center(Tisch Hospital)
New York, New York, 10016, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology - Baylor Sammons Cancer Center
Dallas, Texas, 75251, United States
US Oncology Investigational Products Center (IPC)
Irving, Texas, 75063, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Insitut Gustave Roussy
Villejuif, Cedex, 94805, France
Institut Gustave Roussy
Villejuif, 94805, France
Clinical Research Center Dermatology (CRCD) Dermatoonkologie Charité - Universitätsmedizin Berlin
Berlin, 10115, Germany
Clinical Research Center Dermatology (CRCD) Dermatoonkologie Charité - Universitätsmedizin Berlin
Berlin, 10117, Germany
UniversitätsSpital Zürich Dermatologische Klinik
Zurich, CH-8091, Switzerland
The Beatson West of Scotland Cancer Centre
Glasgow, Glasglow CITY, G12 0YN, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2022
First Posted
October 7, 2022
Study Start
January 3, 2023
Primary Completion (Estimated)
June 6, 2026
Study Completion (Estimated)
June 6, 2026
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
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.