Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Adil Daud, MD
Headshot of Adil Daud
Adil Daud

Description

Summary

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.

Official Title

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

Keywords

Cutaneous Melanoma, Non-small Cell Lung Cancer, Colorectal Neoplasms, Pancreatic Neoplasms, Mesothelioma, NSCLC, Colorectal Cancer, CRC, Pancreatic Cancer, Seattle Genetics, Neoplasms, Melanoma, SGN-BB228

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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:
  • 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 CAN'T join 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

Locations

  • UCSF | HDFCCC - Hematopoietic Malignancies accepting new patients
    San Francisco California 94158 United States
  • University of California Los Angeles Medical Center accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UCSF

  • Adil Daud, MD
    Professor, Medicine, School of Medicine. Authored (or co-authored) 202 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Seagen Inc.
ID
NCT05571839
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 275 study participants
Last Updated