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

Status: administratively complete

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.

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

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.

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

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