NCT02216890

Safety Study of SGN-CD70A in Cancer Patients

Study Contact:

Study Phase:

PHASE1

Recruitment Status:

COMPLETED

NCT ID:

NCT02216890

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

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

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.

Eligibility

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

Disease(s) and\or Condition(s)

Renal Cell Carcinoma

Mantle-Cell Lymphoma

Diffuse, Large B-Cell, Lymphoma

Follicular Lymphoma, Grade 3

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: SGN-CD70A
- Description: Given intravenously every 3 weeks (or an alternate dosing schedule up to every 6 weeks)
- Arm Group Labels: SGN-CD70A

Sponsor

Seagen Inc.