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NCT01901653 (Clinical Trial / SC16LD6.5 / rovalpituzumab tesirine (Rova-T))

Study Title
SC16LD6.5 in Recurrent Small Cell Lung Cancer (NCT01901653)

Trial Description
The purpose of this study is to assess the safety and tolerability of SC16LD6.5, also known as rovalpituzumab tesirine (Rova-T), at different dose levels in patients with small cell lung cancer whose cancer has progressed or recurred following standard chemotherapy. Once a safe and tolerable dose is determined, the anti-cancer activity of SC16LD6.5 will be assessed by measuring the extent of tumor shrinkage. SC16LD6.5 is an antibody-drug conjugate or ADC).

The antibody (SC16) targets a protein that appears to be expressed on the surface of most small cell lung cancers that have been assessed using an immunohistochemical assay. The drug, D6.5, is a very potent form of chemotherapy, specifically a DNA-damaging agent, that is cell cycle independent. ADC’s theoretically provide more precise delivery of chemotherapy to cancer cells, possibly improving effectiveness relative to toxicities.

This trial is sponsored by Stem Centrx.

Study Data

  • Condition: Recurrent Small Cell Lung Cancer
  • Interventions:
  • Phase: I & II
  • Estimated Enrollment: 75
  • Start: July 2013
  • Estimated Completion: June 2015
  • Last verified: April 2015

Study Schematic

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Last Editorial review: September 29, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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