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CompletedNCT02216890Updated Apr 19, 2018

Safety Study of SGN-CD70A in Cancer Patients

A Phase 1 interventional study of SGN-CD70A in Renal Cell Carcinoma, Mantle-Cell Lymphoma and Diffuse, Large B-Cell, Lymphoma, sponsored by Seagen Inc.. Completed at 17 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-19.

Sponsored by Seagen Inc. (part of Pfizer) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

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

Keywords

  • Renal Cell Carcinoma
  • Mantle-Cell Lymphoma
  • Diffuse, Large B-Cell, Lymphoma
  • Follicular Lymphoma, Grade 3
  • Antibody-Drug Conjugate
  • CD70 Antigen
  • Drug Therapy
03

In context

Carcinoma, Renal Cell

1,992 studies on the registry are indexed under Carcinoma, Renal Cell; 387 are open to participants now.

This study's enrollment of 38 is close to the median of 42 across 1,501 interventional studies indexed under Carcinoma, Renal Cell.

Browse Carcinoma, Renal Cell studies →

Lead sponsor

Seagen Inc. is the lead sponsor of 88 studies on the registry; 1 is open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 14 (52%) have results posted.

First submitted before Seagen Inc. became part of Pfizer.

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

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

Study arms

  • Experimental
    SGN-CD70A

    Drug: SGN-CD70A

Interventions

  • DrugSGN-CD70A

    Given intravenously every 3 weeks (or an alternate dosing schedule up to every 6 weeks)

06

What researchers measure

Primary outcomes

  1. Incidence of adverse events

    Time frame: Through 1 month following last dose

  2. Incidence of laboratory abnormalities

    Time frame: Through 1 month following last dose

Secondary outcomes

  1. Blood concentrations of SGN-CD70A and metabolites

    Time frame: Through 3 to 6 weeks after dosing

  2. Incidence of antitherapeutic antibodies

    Time frame: Through 1 month following last dose

  3. Objective response rate

    Time frame: Through 1 month following last dose

  4. Progression-free survival

    Time frame: Approximately 3 years

  5. Duration of response

    Time frame: Approximately 3 years

Other outcomes

  1. Exploratory biomarkers of pharmacodynamic effects due to SGN-CD70A

    Time frame: Through 1 month following last dose

07

Study locations

17 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
  • City of Hope National Medical Center
    Duarte, California 91010-3000, United States
  • Cardinal Bernardin Cancer Center / Loyola University Medical Center
    Maywood, Illinois 60153, United States
  • University of Michigan Comprehensive Cancer Center
    Ann Arbor, Michigan 48109, United States
  • Karmanos Cancer Institute / Wayne State University
    Detroit, Michigan 48201, United States
  • Comprehensive Cancer Centers of Nevada
    Las Vegas, Nevada 89169, United States
  • James P. Wilmot Cancer Center / University of Rochester Medical Center
    Rochester, New York 14642, United States
  • UNC Lineberger Comprehensive Cancer Center / University of North Carolina
    Chapel Hill, North Carolina 27599, United States
  • University of Cincinnati Cancer Institute
    Cincinnati, Ohio 45267, United States
  • Case Western Reserve University / University Hospitals Case Medical Center
    Cleveland, Ohio 44106, United States
  • University of Pennsylvania / Perelman Center for Advanced Medicine
    Philadelphia, Pennsylvania 19104, United States
  • Medical University of South Carolina/Hollings Cancer Center
    Charleston, South Carolina 29425, United States
  • Texas Oncology - Austin Midtown
    Austin, Texas 78705, United States
  • Methodist Cancer Center
    Houston, Texas 77030, United States
  • University of Texas Health Science Center at San Antonio
    San Antonio, Texas 78229, United States
  • Seattle Cancer Care Alliance / University of Washington
    Seattle, Washington 98109-1023, United States
  • Northwest Cancer Specialists, P.C.
    Vancouver, Washington 98684, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2014 to primary completion in Feb 2017, 30 months.

Of 121 industry-sponsored phase 1 interventional studies under Carcinoma, Renal Cell, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 65. This study's 30 months is below that.

Counting every sponsor, half of 200 studies reached it within 51 months; a quarter within 32 and three quarters within 74.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 12, 2014
First posted
Aug 15, 2014
StartActual
Aug 2014
Primary completionActual
Feb 15, 2017
CompletionActual
Feb 15, 2017
Last update
Apr 19, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02216890
Lead sponsor
Seagen Inc.
Responsible party
Sponsor
First posted
Aug 15, 2014
Start date
Aug 2014
Primary completion
Feb 15, 2017
Completion
Feb 15, 2017
Last update
Apr 19, 2018

Study contacts

Elaina Gartner, MD
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 Apr 2018. You cannot join it, but the record below documents what was studied.

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