Clinical Trials /

Safety Study of SGN-CD70A in Cancer Patients

NCT02216890

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.

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
  • Mantle Cell Lymphoma
  • Renal Cell Carcinoma
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

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

Trial Conditions

  • Renal Cell Carcinoma
  • Mantle-Cell Lymphoma
  • Diffuse, Large B-Cell, Lymphoma
  • Follicular Lymphoma, Grade 3

Trial Interventions

DrugSynonymsArms
SGN-CD70ASGN-CD70A

Trial 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.

Detailed Description

Trial Arms

NameTypeDescriptionInterventions
SGN-CD70AExperimental
  • SGN-CD70A

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:Both
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of adverse events
Time Frame:Through 1 month following last dose
Safety Issue:Yes
Description:

Secondary Outcome Measures

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:

Trial Keywords

  • Renal Cell Carcinoma
  • Mantle-Cell Lymphoma
  • Diffuse, Large B-Cell, Lymphoma
  • Follicular Lymphoma, Grade 3
  • Antibody-Drug Conjugate
  • CD70 Antigen
  • Drug Therapy