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

Phase 1TerminatedNCT02500914

Stemcentrx35 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Small Cell Lung Cancer

Interventions

SC-002DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Unnamed facility

Ann Arbor, Michigan, United States

Unnamed facility

St Louis, Missouri, United States

Unnamed facility

New York, New York, United States

Unnamed facility

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Maximum tolerated dose

Time frame: 6 months

Number of subjects with adverse events as a measure of safety and tolerability

Time frame: 6 months

Secondary Outcomes

Pharmacokinetics of SC-002

Standard PK variables to be assessed include AUC, Tmax, Cmax, Ctrough, T1/2, CL, Vss

Time frame: Cycle 1 and 4: days 1, 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 only

RECIST v1.1 assessed objective response rate

Time frame: 6 months

Data from ClinicalTrials.gov

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