Carcinoma, Renal Cell, Lymphoma, Non-Hodgkin
Conditions
Keywords
Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD70, Lymphoma, Non-Hodgkin, Carcinoma, Renal Cell, Immunotherapy, Drug Therapy, monomethylauristatin F
Brief summary
This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety of SGN-75 in patients with CD70-positive relapsed or refractory non-Hodgkin lymphoma or metastatic renal cell carcinoma.
Interventions
DRUGSGN-75
SGN-75 (IV) in 21- or 28-day cycles; dose range: 0.3-9 mg/kg
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
* Pathologically-confirmed diagnosis of NHL or RCC * Relapsed, refractory, or progressive disease following at least 1 prior systemic therapy * Confirmed CD70 expression * Measurable disease, defined as at least 1 lesion \>1.5 cm in the greatest transverse diameter for patients with NHL, and at least 1 non-resectable tumor lesion \> or equal to 10 mm in diameter for patients with RCC
Exclusion criteria
* Previously received an allogeneic transplant * History of another primary malignancy that has not been in remission for at least 3 years * Prior anti-CD70-directed therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events and laboratory abnormalities | Through 1 month following last dose |
Secondary
| Measure | Time frame |
|---|---|
| Best clinical response | Every 2 months |
| Duration of response, progression-free survival | Every 3 months until progression of disease or initiation of new treatment for cancer |
| Blood concentrations of SGN-75 and metabolites | Through 1 month following last dose |
| Incidence of antitherapeutic antibodies | Through 1 month following last dose |
Countries
United States
Outcome results
None listed