Diffuse, Large B-Cell, Lymphoma, Follicular Lymphoma, Grade 3, Mantle-Cell Lymphoma, Renal Cell Carcinoma
Conditions
Keywords
Renal Cell Carcinoma, Mantle-Cell Lymphoma, Diffuse, Large B-Cell, Lymphoma, Follicular Lymphoma, Grade 3, Antibody-Drug Conjugate, CD70 Antigen, Drug Therapy
Brief summary
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.
Interventions
DRUGSGN-CD70A
Given intravenously every 3 weeks (or an alternate dosing schedule up to every 6 weeks)
Sponsors
Seagen Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of laboratory abnormalities | Through 1 month following last dose |
| Incidence of adverse events | Through 1 month following last dose |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate | Through 1 month following last dose |
| Progression-free survival | Approximately 3 years |
| Blood concentrations of SGN-CD70A and metabolites | Through 3 to 6 weeks after dosing |
| Duration of response | Approximately 3 years |
| Incidence of antitherapeutic antibodies | Through 1 month following last dose |
Other
| Measure | Time frame |
|---|---|
| Exploratory biomarkers of pharmacodynamic effects due to SGN-CD70A | Through 1 month following last dose |
Countries
United States
Outcome results
None listed