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Safety Study of SGN-CD70A in Cancer Patients

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Seagen

Status and phase

Completed
Phase 1

Conditions

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

Treatments

Drug: SGN-CD70A

Study type

Interventional

Funder types

Industry

Identifiers

NCT02216890
SGN70A-001

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

38 participants in 1 patient group

SGN-CD70A
Experimental group
Treatment:
Drug: SGN-CD70A

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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