NCT01901653

Rovalpituzumab Tesirine (SC16LD6.5) in Recurrent Small Cell Lung Cancer

Phase I/II Open Label Dose Escalation Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of SC16LD6.5 as a Single Agent in Patients With Recurrent Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Stemcentrx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and tolerability of rovalpituzumab tesirine (SC16LD6.5) 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 (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.

Conditions

• Recurrent Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Rovalpituzumab tesirine (SC16LD6.5)

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-11-28
• Completion: 2016-11-28
• First posted: 2013-07-17
• Last updated: 2018-08-09
• Results posted: 2018-07-11

Locations

8 sites across 1 country: United States