A Phase I/II Study of SC16LD6.5 in Patients with Recurrent Small Cell Lung Cancer

Protocol
13-184
Full Title
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
Phase
I/II
Purpose

The purpose of this study is to find the highest dose of the investigational drug SC16LD6.5 that can be given safely to patients with small cell lung cancer that has come back after treatment, and to evaluate the effectiveness of this treatment in these patients. SC16LD6.5 is an “antibody-drug conjugate.” This means it contains an antibody (a protein which binds to a specific site on cells) and an anticancer drug.

In the case of SC16LD6.5, the antibody binds to a specific protein on the surface of small cell lung cancer cells. Then it releases the anticancer drug to kill the cancer cell. SC16LD6.5 is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have small cell lung cancer that came back despite one or two prior regimens of chemotherapy, at least one of which included a platinum-containing drug.
  • Patients must have recovered from the serious side effects of prior therapies.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is open to patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. M. Catherine Pietanza at 646-888-4203.

Disease(s)
Lung Cancer, Small Cell
Locations

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