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

Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02500914
• Other study ID #: SCRX002-001
• Status: Terminated
• Phase: Phase 1
• Start date: June 2015
• Est. completion date: August 23, 2018

Study information

• Verified date: October 2018
• Source: Stemcentrx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: August 23, 2018
• Est. primary completion date: August 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Neuroendocrine
• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stemcentrx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose		6 months
Primary	Number of subjects with adverse events as a measure of safety and tolerability		6 months
Secondary	Pharmacokinetics of SC-002	Standard PK variables to be assessed include AUC, Tmax, Cmax, Ctrough, T1/2, CL, Vss	Cycle 1 and 4: days 1, 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 only
Secondary	RECIST v1.1 assessed objective response rate		6 months