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

May 3, 2024 updated by: Seagen Inc.

A Phase 1 Study of SGN-BB228 in Advanced Melanoma and Other Solid Tumors

This study will test the safety of a drug called 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 SGN-BB228 should be given to participants. Part C will use the information from Parts A and B to see if SGN-BB228 is safe and if it works to treat solid tumor cancers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

275

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • Ottawa Hospital Cancer Centre
        • Principal Investigator:
          • Arif Awan
    • Other
      • Toronto, Other, Canada, M5G 2C1
        • Recruiting
        • University Health Network, Princess Margaret Hospital
        • Principal Investigator:
          • Samuel Saibil
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital
        • Principal Investigator:
          • Wilson H. Miller
  • France
    • Other
      • Villejuif Cedex, Other, France, 94805
        • Recruiting
        • Institut Gustave Roussy
        • Principal Investigator:
          • Caroline Robert
  • Germany
    • Other
      • Berlin, Other, Germany, 10117
        • Recruiting
        • Charite Universitatsmedizin Berlin
        • Principal Investigator:
          • Thomas Eigentler
  • Switzerland
    • Other
      • Zurich, Other, Switzerland, 8091
        • Recruiting
        • Universitatsspital Zurich
        • Principal Investigator:
          • Reinhard Dummer
  • United Kingdom
    • Other
      • Glasgow, Other, United Kingdom, G12 0Yn
        • Recruiting
        • NHS Greater Glasgow and Clyde (NHSGGC) - The Beatson West of Scotland Cancer Centre
        • Principal Investigator:
          • Jeff Evans
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California Los Angeles Medical Center
        • Principal Investigator:
          • Antoni Ribas
        • Contact:
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
        • Principal Investigator:
          • Adil Daud, MD
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Sarah Cannon Research Institute at HealthONE - Denver
        • Principal Investigator:
          • Jason Henry
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Hospitals and Clinics
        • Contact:
        • Principal Investigator:
          • Mohammed M Milhem
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Kamaneh Montazeri
        • Contact:
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute
        • Principal Investigator:
          • Stephen Hodi
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Hospital
        • Principal Investigator:
          • Janice Mehnert
        • Contact:
          • Shirly Gholian
          • Phone Number: 212-731-6262
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Principal Investigator:
          • April Salama
    • Texas
      • Dallas, Texas, United States, 75251
        • Recruiting
        • Texas Oncology - Baylor Sammons Cancer Center
        • Principal Investigator:
          • Charles Cowey
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington
        • Principal Investigator:
          • Lisa Tachiki, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SGN-BB228
SGN-BB228 monotherapy
Drug: SGN-BB228
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)
Time Frame: Through 30 days after the last study treatment; approximately 7 months
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
Time Frame: Through 30 days after the last study treatment; approximately 7 months
Through 30 days after the last study treatment; approximately 7 months
Number of participants with dose limiting toxicities
Time Frame: Up to 28 days
Up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with antidrug antibodies
Time Frame: Through 30 days after the last study treatment; approximately 7 months
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)
Time Frame: Through 30 days after the last study treatment; approximately 7 months
To be summarized using descriptive statistics
Through 30 days after the last study treatment; approximately 7 months
PK parameter - Maximum Concentration (Cmax)
Time Frame: Through 30 days after the last study treatment; approximately 7 months
To be summarized using descriptive statistics
Through 30 days after the last study treatment; approximately 7 months
PK parameter - Time to maximum concentration (Tmax)
Time Frame: Through 30 days after the last study treatment; approximately 7 months
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)
Time Frame: Through 30 days after the last study treatment; approximately 7 months
To be summarized using descriptive statistics
Through 30 days after the last study treatment; approximately 7 months
PK parameter - Trough concentration (Ctrough)
Time Frame: Through 30 days after the last study treatment; approximately 7 months
To be summarized using descriptive statistics
Through 30 days after the last study treatment; approximately 7 months
Objective response rate (ORR)
Time Frame: Up to approximately 1 year
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)
Time Frame: Up to approximately 1 year
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)
Time Frame: Up to approximately 1 year
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)
Time Frame: Approximately 2 years
The time from the start of study treatment to death due to any cause
Approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Investigators

  • Study Director: Medical Monitor, Seagen Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2023

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

September 30, 2028

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)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGNBB228-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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