NCT02500914

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Stemcentrx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1a/1b study of SC-002 in patients with relapsed small cell lung cancer (SCLC) or 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 or LCNEC, to evaluate the side effects of SC-002, and to assess the anti-cancer activity of SC-002.

Detailed description

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.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	SC-002	SC-002 will be administered by IV infusion over approximately 30 minutes every 3 weeks

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-08-23
• Completion: 2018-08-23
• First posted: 2015-07-17
• Last updated: 2018-10-05

Locations

4 sites across 1 country: United States