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

• Status: Terminated
• Trial end date: 2018-08-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stemcentrx

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed SCLC (either limited or extensive disease) or LCNEC, that has relapsed from the most current treatment or was refractory to treatment

• Evidence of progressive disease during or following no more than 2 prior chemotherapy regimens

• Measurable disease as defined by RECIST

• ECOG performance status of 0 or 1

• Adequate hematological and organ function as confirmed by laboratory values

• Treatment with anticancer/investigational drugs, therapy ≤ 4 weeks prior to first dose of SC-002

Exclusion Criteria:

• Active central nervous system metastases

• Uncontrolled cardiac disease

• Positive serology for hepatitis B or hepatitis C or known HIV infection

• Presence of any condition that may increase the risks associated with study participation and interfere with the interpretation of study results