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CompletedNCT01015911Updated Dec 18, 2014

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

A Phase 1 interventional study of SGN-75 in Carcinoma, Renal Cell and Lymphoma, Non-Hodgkin, sponsored by Seagen Inc.. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-18.

Sponsored by Seagen Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
58
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Carcinoma, Renal Cell
  • Lymphoma, Non-Hodgkin

Keywords

  • Antibodies, Monoclonal
  • Antibody-Drug Conjugate
  • Antigens, CD70
  • Lymphoma, Non-Hodgkin
  • Carcinoma, Renal Cell
  • Immunotherapy
  • Drug Therapy
  • monomethylauristatin F
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 58 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Seagen Inc. is the lead sponsor of 84 studies on the registry; 1 is open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 13 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • Experimental
    1

    SGN-75

    Drug: SGN-75

Interventions

  • DrugSGN-75

    SGN-75 (IV) in 21- or 28-day cycles; dose range: 0.3-9 mg/kg

06

What researchers measure

Primary outcomes

  1. Incidence of adverse events and laboratory abnormalities

    Time frame: Through 1 month following last dose

Secondary outcomes

  1. Best clinical response

    Time frame: Every 2 months

  2. Duration of response, progression-free survival

    Time frame: Every 3 months until progression of disease or initiation of new treatment for cancer

  3. Blood concentrations of SGN-75 and metabolites

    Time frame: Through 1 month following last dose

  4. Incidence of antitherapeutic antibodies

    Time frame: Through 1 month following last dose

07

Study locations

9 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294-3300, United States
  • City of Hope National Medical Center
    Duarte, California 91010-3000, United States
  • UCLA Medical Center / University of California at Los Angeles
    Los Angeles, California 90095-1678, United States
  • Karmanos Cancer Institute / Wayne State University
    Detroit, Michigan 48201, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10021, United States
  • Sarah Cannon Research Institute
    Nashville, Tennessee 37203, United States
  • MD Anderson Cancer Center / University of Texas
    Houston, Texas 77030, United States
  • Seattle Cancer Care Alliance / University of Washington
    Seattle, Washington 98109-1023, United States
08

References and documents

Publications

  • Tannir NM, Forero-Torres A, Ramchandren R, Pal SK, Ansell SM, Infante JR, de Vos S, Hamlin PA, Kim SK, Whiting NC, Gartner EM, Zhao B, Thompson JA. Phase I dose-escalation study of SGN-75 in patients with CD70-positive relapsed/refractory non-Hodgkin lymphoma or metastatic renal cell carcinoma. Invest New Drugs. 2014 Dec;32(6):1246-57. doi: 10.1007/s10637-014-0151-0. Epub 2014 Aug 22. PubMed 25142258 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01015911
Lead sponsor
Seagen Inc.
Responsible party
Sponsor
First posted
Nov 18, 2009
Start date
Nov 2009
Primary completion
Nov 2011
Completion
Mar 2012
Last update
Dec 18, 2014

Study contacts

Nancy Whiting, PharmD, BCOP
study director · Seagen Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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