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NCT Number: NCT01015911

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

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.

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Key information

Conditions

Carcinoma, Renal Cell Adenocarcinoma Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Kidney Diseases Kidney Neoplasms Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Male Urogenital Diseases 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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

SGN-75

Drug

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

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

Sponsors and collaborators

Lead sponsor

Seagen Inc.

Industry

Registry information

Official study title

A Phase 1, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of SGN-75 in Patients With CD70-positive Relapsed or Refractory Non-Hodgkin Lymphoma or Metastatic Renal Cell Carcinoma

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Nov 18, 2009
Registry last updated
Dec 18, 2014

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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