A Phase 1 Dose-escalation Trial of SGN-75 in CD70-positive Non-Hodgkin Lymphoma or Renal Cell Carcinoma

Phase 1

Completed

• Conditions: Carcinoma, Renal Cell; Lymphoma, Non-Hodgkin
• Interventions: Drug: SGN-75

• Registration Number: NCT01015911
• Lead Sponsor: Seagen Inc.

Brief Summary

This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety of SGN-75 in patients with CD70-positive relapsed or refractory non-Hodgkin lymphoma or metastatic renal cell carcinoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-13
• Study First Submitted QC: 2009-11-16
• Study First Posted: 2009-11-18
• Primary Completion: 2011-11
• Study Completion: 2012-03
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-17
• Last Update Posted: 2014-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Pathologically-confirmed diagnosis of NHL or RCC
• Relapsed, refractory, or progressive disease following at least 1 prior systemic therapy
• Confirmed CD70 expression
• Measurable disease, defined as at least 1 lesion >1.5 cm in the greatest transverse diameter for patients with NHL, and at least 1 non-resectable tumor lesion > or equal to 10 mm in diameter for patients with RCC

Exclusion Criteria

• Previously received an allogeneic transplant
• History of another primary malignancy that has not been in remission for at least 3 years
• Prior anti-CD70-directed therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	SGN-75	SGN-75

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events and laboratory abnormalities	Through 1 month following last dose

Secondary Outcome Measures

Name	Time	Method
Duration of response, progression-free survival	Every 3 months until progression of disease or initiation of new treatment for cancer
Blood concentrations of SGN-75 and metabolites	Through 1 month following last dose
Incidence of antitherapeutic antibodies	Through 1 month following last dose
Best clinical response	Every 2 months

Trial Locations

Locations (9)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

City of Hope National Medical Center; 🇺🇸 Duarte, California, United States

UCLA Medical Center / University of California at Los Angeles; 🇺🇸 Los Angeles, California, United States

Karmanos Cancer Institute / Wayne State University; 🇺🇸 Detroit, Michigan, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States

MD Anderson Cancer Center / University of Texas; 🇺🇸 Houston, Texas, United States

Seattle Cancer Care Alliance / University of Washington; 🇺🇸 Seattle, Washington, United States