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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Neoplasms; Pancreatic Neoplasms; Mesothelioma; Non-small Cell Lung Cancer; Cutaneous Melanoma
• Intervention / Treatment: Drug: PF-08046049

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital Cancer Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital
• France
  • Villejuif, France, 94805
    • Institut Gustave Roussy
  • Cedex
    • Villejuif, Cedex, France, 94805
      • Insitut Gustave Roussy
• Germany
  • Berlin, Germany, 10115
    • Clinical Research Center Dermatology (CRCD) Dermatoonkologie Charité - Universitätsmedizin Berlin
  • Berlin, Germany, 10117
    • Clinical Research Center Dermatology (CRCD) Dermatoonkologie Charité - Universitätsmedizin Berlin
• Switzerland
  • Zurich, Switzerland, CH-8091
    • UniversitätsSpital Zürich Dermatologische Klinik
• United Kingdom
  • Glasglow CITY
    • Glasgow, Glasglow CITY, United Kingdom, G12 0YN
      • The Beatson West of Scotland Cancer Centre
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Los Angeles, California, United States, 90095
      • UCLA Hematology/Oncology
    • Los Angeles, California, United States, 90095
      • Ronald Reagan UCLA Medical Center, Drug Information Center
    • Los Angeles, California, United States, 90024
      • UCLA Hematology/Oncology - Administrative Office
    • Los Angeles, California, United States, 90025
      • The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate
    • Pasadena, California, United States, 91105
      • UCLA Hematology/ Oncology- Pasadena
    • San Francisco, California, United States, 94143
      • UCSF Helen Diller Family Comprehensive Cancer Center
    • San Francisco, California, United States, 94158
      • UCSF Medical Center, Investigational Pharmacy
    • Santa Barbara, California, United States, 93101
      • UCLA Hematology/Oncology - Santa Barbara
    • Santa Monica, California, United States, 90404
      • The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate (Emergency Back-Up Only)
    • Westlake Village, California, United States, 91361
      • UCLA Hematology - Oncology Clinic - Westlake Village
  • Colorado
    • Denver, Colorado, United States, 80209
      • Quest Diagnostics Incorporated - Denver
    • Denver, Colorado, United States, 80218
      • Presbyterian/St. Lukes Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Chicago, Illinois, United States, 60611
      • Northwestern Medical Group
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute (DFCI)
    • Boston, Massachusetts, United States, 02115
      • BWH
  • New Jersey
    • Raritan, New Jersey, United States, 08869
      • Laboratory Corporation of America
  • New York
    • New York, New York, United States, 10016
      • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
    • New York, New York, United States, 10016
      • NYU Langone Hospitals, NYU Langone Rusk Ambulatory Surgical Pharmacy
    • New York, New York, United States, 10016
      • NYU Langone Medical Center(Tisch Hospital)
    • New York, New York, United States, 10016
      • Ambulatory Care Center at NYU Langone Medical Center
  • Texas
    • Dallas, Texas, United States, 75246
      • Texas Oncology-Baylor Charles A. Sammons Cancer Center
    • Dallas, Texas, United States, 75251
      • Texas Oncology - Baylor Sammons Cancer Center
    • Irving, Texas, United States, 75063
      • US Oncology Investigational Products Center (IPC)
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-08046049; PF-08046049 monotherapy	Drug: PF-08046049; Given into the vein (IV; intravenous)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with antidrug antibodies	To be summarized using descriptive statistics	Through 30 days after the last study treatment; approximately 7 months
Pharmacokinetic (PK) parameter - Area under the curve (AUC)	To be summarized using descriptive statistics	Through 30 days after the last study treatment; approximately 7 months
PK parameter - Maximum Concentration (Cmax)	To be summarized using descriptive statistics	Through 30 days after the last study treatment; approximately 7 months
PK parameter - Time to maximum concentration (Tmax)	To be summarized using descriptive statistics	Through 30 days after the last study treatment; approximately 7 months
PK parameter - Apparent terminal half-life (t1/2)	To be summarized using descriptive statistics	Through 30 days after the last study treatment; approximately 7 months
PK parameter - Trough concentration (Ctrough)	To be summarized using descriptive statistics	Through 30 days after the last study treatment; approximately 7 months
Objective response rate (ORR)	The proportion of participants with a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by the investigator	Up to approximately 1 year
Duration of response (DOR)	The time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of progressive disease (PD) (based on radiographic assessments per RECIST v1.1) or death due to any cause	Up to approximately 1 year
Progression-free survival (PFS)	The time from the start of study treatment to the first documentation of PD (per RECIST v1.1 as assessed by the investigator) or death due to any cause	Up to approximately 1 year
Overall survival (OS)	The time from the start of study treatment to death due to any cause	Approximately 2 years

Collaborators and Investigators

• Sponsor: Seagen, a wholly owned subsidiary of Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2023
• Primary Completion (Estimated): June 6, 2026
• Study Completion (Estimated): June 6, 2026

Study Registration Dates

• First Submitted: October 5, 2022
• First Submitted That Met QC Criteria: October 5, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: NSCLC; Pancreatic Cancer; Colorectal Cancer; CRC
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Intestinal Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Lung Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Lung Neoplasms; Adenoma; Neoplasms, Mesothelial; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Mesothelioma; Pancreatic Neoplasms; Carcinoma, Non-Small-Cell Lung; Melanoma
• Other Study ID Numbers: SGNBB228-001; C5871001 (Other Identifier: Alias Study Number); 2022-502348-11-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No