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

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Seagen

Status and phase

Enrolling
Phase 1

Conditions

Non-small Cell Lung Cancer
Mesothelioma
Colorectal Neoplasms
Pancreatic Neoplasms
Cutaneous Melanoma

Treatments

Drug: SGN-BB228

Study type

Interventional

Funder types

Industry

Identifiers

NCT05571839
SGNBB228-001

Details and patient eligibility

About

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.

Enrollment

275 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

275 participants in 1 patient group

SGN-BB228
Experimental group
Description:
SGN-BB228 monotherapy
Treatment:
Drug: SGN-BB228

Trial contacts and locations

19

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Central trial contact

Seagen Trial Information Support

Data sourced from clinicaltrials.gov

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