NCT01015911

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2009

Typical duration for phase_1

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

December 18, 2014

Status Verified

December 1, 2014

Enrollment Period

2 years

First QC Date

November 13, 2009

Last Update Submit

December 17, 2014

Conditions

Carcinoma, Renal CellLymphoma, Non-Hodgkin

Keywords

Antibodies, MonoclonalAntibody-Drug ConjugateAntigens, CD70Lymphoma, Non-HodgkinCarcinoma, Renal CellImmunotherapyDrug Therapymonomethylauristatin F

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events and laboratory abnormalities

    Through 1 month following last dose

Secondary Outcomes (4)

  • Best clinical response

    Every 2 months

  • 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

Study Arms (1)

1

EXPERIMENTAL

SGN-75

Drug: SGN-75

Interventions

SGN-75DRUG

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

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3300, United States

Location

City of Hope National Medical Center

Duarte, California, 91010-3000, United States

Location

UCLA Medical Center / University of California at Los Angeles

Los Angeles, California, 90095-1678, United States

Location

Karmanos Cancer Institute / Wayne State University

Detroit, Michigan, 48201, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center / University of Texas

Houston, Texas, 77030, United States

Location

Seattle Cancer Care Alliance / University of Washington

Seattle, Washington, 98109-1023, United States

Location

Related Publications (1)

  • 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.

    PMID: 25142258RESULT

MeSH Terms

Conditions

Carcinoma, Renal CellLymphoma, Non-Hodgkin

Interventions

SGN-75 antibody-drug conjugate

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesLymphomaLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Nancy Whiting, PharmD, BCOP

    Seagen Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2009

First Posted

November 18, 2009

Study Start

November 1, 2009

Primary Completion

November 1, 2011

Study Completion

March 1, 2012

Last Updated

December 18, 2014

Record last verified: 2014-12

Locations

US(9)