A Phase II Study of DS-7300a in People with Previously Treated Extensive Stage Small Cell Lung Cancer

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Full Title

A Phase 2, Multicenter, Randomized, Open Label Study Of DS-7300A, A B7-H3 Antibody Drug Conjugate (ADC), in Subjects with Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drug DS-7300a in people with extensive stage small cell lung cancer (ES-SCLC) that persists despite prior treatment. Many ES-SCLC tumors make a protein called B7-H3, which helps them survive and grow. DS-7300a is designed to target and kill cancer cells that make B7-H3.

Participants in this study will be randomly assigned to receive one of two dosages of DS-7300a. This medication is given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have ES-SCLC that has been treated with at least one but no more than three prior regimens of therapy.
  • The serious side effects of previous treatments should go away before DS-7300a is given.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

Contact

For more information about this study and to ask about eligibility, please contact the office of Dr. Charles Rudin at 646-888-4527.

Protocol

22-344

Phase

Phase II (phase 2)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05280470