Clinical Trial: SC-002 in Small Cell Lung Cancer and Large Cell Neuroendocrine Carcinoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 1a/1b Dose Escalation and Expansion Study of Single-agent SC-002 in Subjects With Relapsed or Refractory Small Cell Lung Cancer and Large Cell Neuroendocrine Carcinoma

Brief Summary:

This is a Phase 1a/1b study of SC-002 in patients with relapsed small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC). SC-002 is an antibody-drug conjugate (ADC) comprised of a monoclonal antibody linked to a potent chemotherapy.

The purpose of this study is to assess the safety and tolerability of SC-002 at different dose levels, to determine the highest dose of SC-002 that can be given to patients with SCLC and LCNEC, to evaluate the side effects of SC-002, and to assess the anti-cancer activity of SC-002.


Detailed Summary:

Part 1A is a dose escalation study in patients with small cell lung cancer or large cell neuroendocrine carcinoma with cytologically confirmed, limited or extensive SCLC or LCNEC that have relapsed or refractory limited or extensive disease following no more than 2 prior chemotherapy regimens.

Part 1B is an expansion study where patients will be enrolled and treated in order to further characterize safety and preliminary efficacy in patients with SCLC or LCNEC and further characterize PK, immunogenicity and target expression and possible relationship to clinical outcome.


Sponsor: Stemcentrx

Current Primary Outcome:

  • Maximum tolerated dose [ Time Frame: 6 months ]
  • Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: 6 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pharmacokinetics of SC-002 [ Time Frame: Cycle 1 and 4: days 1, 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 only ]
    Standard PK variables to be assessed include AUC, Tmax, Cmax, Ctrough, T1/2, CL, Vss
  • RECIST v1.1 assessed objective response rate [ Time Frame: 6 months ]


Original Secondary Outcome: Same as current

Information By: Stemcentrx

Dates:
Date Received: July 6, 2015
Date Started: June 2015
Date Completion: January 2019
Last Updated: June 24, 2016
Last Verified: June 2016