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

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

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

Intervention / Treatment
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* Drug: SGN-BB228


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SGN-BB228<br>SGN-BB228 monotherapy | Drug: SGN-BB228<br>* Given into the vein (IV; intravenous)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AEs) | 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 |  | Through 30 days after the last study treatment; approximately 7 months | 
| Number of participants with dose limiting toxicities |  | Up to 28 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRC, NSCLC, Colorectal Cancer, Pancreatic Cancer, Seattle Genetics