Safety Study of SGN-CD70A in Cancer Patients

Study Overview
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Brief Summary
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This study will examine the safety profile of SGN-CD70A. The study will test increasing doses of SGN-CD70A given every 3 weeks (or an alternate dosing schedule up to every 6 weeks) to small groups of patients. The goal is to find the highest dose of SGN-CD70A that can be given to patients without causing unacceptable side effects. The pharmacokinetics and antitumor activity of SGN-CD70A will also be evaluated.

Official Title
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A Phase 1 Trial of SGN-CD70A in Patients With CD70-Positive Malignancies

Conditions
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Renal Cell Carcinoma, Mantle-Cell Lymphoma, Diffuse, Large B-Cell, Lymphoma, Follicular Lymphoma, Grade 3

Intervention / Treatment
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* Drug: SGN-CD70A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Metastatic renal cell carcinoma, mantle cell lymphoma, or diffuse large B-cell lymphoma including Grade 3b follicular lymphoma Relapsed, refractory, or progressive disease following at least 2 prior systemic therapies Confirmed positive CD70 expression on tumor tissue Eastern Cooperative Oncology Group performance status 0 or 1 Adequate baseline hematologic, pulmonary, renal, and hepatic function Measurable disease Exclusion Criteria: Prior treatment with anti-CD70 directed therapy unless CD70 expression is confirmed on tumor tissue obtained after the treatment Patients <100 days since prior allogeneic stem cell transplant Less than 4 weeks since prior treatment; or 2 weeks if patient experienced disease progression on the prior 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-CD70A<br> | Drug: SGN-CD70A<br>* Given intravenously every 3 weeks (or an alternate dosing schedule up to every 6 weeks)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | Through 1 month following last dose | 
| Incidence of laboratory abnormalities |  | Through 1 month following last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood concentrations of SGN-CD70A and metabolites |  | Through 3 to 6 weeks after dosing | 
| Incidence of antitherapeutic antibodies |  | Through 1 month following last dose | 
| Objective response rate |  | Through 1 month following last dose | 
| Progression-free survival |  | Approximately 3 years | 
| Duration of response |  | Approximately 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal Cell Carcinoma, Mantle-Cell Lymphoma, Diffuse, Large B-Cell, Lymphoma, Follicular Lymphoma, Grade 3, Antibody-Drug Conjugate, CD70 Antigen, Drug Therapy