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.
Completed
Phase 1
| Drug | Synonyms | Arms |
|---|---|---|
| SGN-CD70A | SGN-CD70A |
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.
| Name | Type | Description | Interventions |
|---|---|---|---|
| SGN-CD70A | Experimental |
|
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | Both |
| Healthy Volunteers: | No |
| Measure: | Incidence of adverse events |
| Time Frame: | Through 1 month following last dose |
| Safety Issue: | Yes |
| Description: |
| Measure: | Blood concentrations of SGN-CD70A and metabolites |
| Time Frame: | Through 3 to 6 weeks after dosing |
| Safety Issue: | No |
| Description: |
| Measure: | Incidence of antitherapeutic antibodies |
| Time Frame: | Through 1 month following last dose |
| Safety Issue: | Yes |
| Description: |
| Measure: | Objective response rate |
| Time Frame: | Through 1 month following last dose |
| Safety Issue: | No |
| Description: |
| Measure: | Progression-free survival |
| Time Frame: | Approximately 3 years |
| Safety Issue: | No |
| Description: |
| Measure: | Duration of response |
| Time Frame: | Approximately 3 years |
| Safety Issue: | No |
| Description: |
