Description:
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.
Title
- Brief Title: Safety Study of SGN-CD70A in Cancer Patients
- Official Title: A Phase 1 Trial of SGN-CD70A in Patients With CD70-Positive Malignancies
Clinical Trial IDs
- ORG STUDY ID:
SGN70A-001
- NCT ID:
NCT02216890
Conditions
- Renal Cell Carcinoma
- Mantle-Cell Lymphoma
- Diffuse, Large B-Cell, Lymphoma
- Follicular Lymphoma, Grade 3
Interventions
Drug | Synonyms | Arms |
---|
SGN-CD70A | | SGN-CD70A |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
SGN-CD70A | Experimental | | |
Eligibility Criteria
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: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of adverse events |
Time Frame: | Through 1 month following last dose |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Blood concentrations of SGN-CD70A and metabolites |
Time Frame: | Through 3 to 6 weeks after dosing |
Safety Issue: | |
Description: | |
Measure: | Incidence of antitherapeutic antibodies |
Time Frame: | Through 1 month following last dose |
Safety Issue: | |
Description: | |
Measure: | Objective response rate |
Time Frame: | Through 1 month following last dose |
Safety Issue: | |
Description: | |
Measure: | Progression-free survival |
Time Frame: | Approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Duration of response |
Time Frame: | Approximately 3 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Seagen Inc. |
Trial Keywords
- Renal Cell Carcinoma
- Mantle-Cell Lymphoma
- Diffuse, Large B-Cell, Lymphoma
- Follicular Lymphoma, Grade 3
- Antibody-Drug Conjugate
- CD70 Antigen
- Drug Therapy
Last Updated
April 19, 2018