SGN-BB228 in Advanced Melanoma and Other Solid Tumors

What is the Purpose of this Study?

The purpose of this study is to evaluate an experimental drug called SGN-BB228 in people with cancer that has come back or did not improve with treatment. SGN-BB228 is designed to find and stick to cancer cells so that it can help the immune cells attack cancer cells. It may also attach to some non-cancer cells in the body. Researchers aim to learn more about the side effects of SGN-BB228 and the best dose of the drug, as well as whether it works to treat certain types of cancers. Participants in this study will have melanoma, lung cancer, colon cancer, pancreatic cancer, or mesothelioma.

Eligibility

* 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.

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

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Where can I participate?

Cedars-Sinai Cancer at The Angeles Clinic and Research Institute

More about this Clinical Trial

What is the full name of this clinical trial?

SGNBB228-001: A phase 1 study of SGN-BB228 in advanced melanoma and other solid tumors

Study Details

Disease Type/Condition

Colon, Lung, Melanoma, Pancreas

Principal Investigator

Hamid, Omid

Co-Investigators

Cathie T Chung, Inderjit Mehmi, Justin Moyers, Kristopher Wentzel, Navid Hafez, Vi K. Chiu

Age Group

Adult

Phase

IRB Number

STUDY00002874

ClinicalTrials.gov ID

NCT05571839

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org