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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05571839
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Seagen Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Medical Monitor
Principal Investigator Affiliation	Seagen Inc.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Canada, France, Germany, Switzerland, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cutaneous Melanoma, Non-small Cell Lung Cancer, Colorectal Neoplasms, Pancreatic Neoplasms, Mesothelioma

Arms & Interventions

Arms

Experimental: SGN-BB228

SGN-BB228 monotherapy

Interventions

Drug: - SGN-BB228

Given into the vein (IV; intravenous)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Los Angeles, California

Status

Recruiting

Address

The Angeles Clinic and Research Institute

Los Angeles, California, 90025

Site Contact

Teresa Mata

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