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Completed

NCT Number: NCT02216890

Safety Study of SGN-CD70A in Cancer Patients

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.

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Key information

Conditions

Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Diffuse, Large B-Cell, Lymphoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Follicular Lymphoma, Grade 3 Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Kidney Diseases Kidney Neoplasms Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Male Urogenital Diseases Mantle-Cell Lymphoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SGN-CD70A

Drug

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

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

Sponsors and collaborators

Lead sponsor

Seagen Inc.

Industry

Registry information

Official study title

A Phase 1 Trial of SGN-CD70A in Patients With CD70-Positive Malignancies

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 15, 2014
Registry last updated
Apr 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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