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

• ClinicalTrials.gov Identifier: NCT02500914
• Recruitment Status: Terminated
• First Posted: July 17, 2015
• Last Update Posted: October 5, 2018
• Sponsor: Stemcentrx
• Information provided by (Responsible Party): Stemcentrx

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Small Cell Lung Cancer	Drug: SC-002	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: June 2015
• Actual Primary Completion Date: August 23, 2018
• Actual Study Completion Date: August 23, 2018

Arms and Interventions

Arm

Intervention/treatment

Experimental: SC-002; Part 1A (Dose Escalation) - IV infusion; safety data will be reviewed prior to dose escalation decision. Dose escalation will complete when recommended dose (RD) is determined. RD will be the maximum tolerated dose (MTD) or lower dose that provides adequate PK exposure, immunogenicity, and preliminary evidence of antitumor activity with tolerability. Part 1B (Dose Expansion) - IV infusion; once MTD and/or RD has been determined in Part 1A, an expansion cohort of approximately 60 patients with SCLC or LCNEC will be enrolled to further characterize the safety profile and clinical activity of the RD. Patients may continue treatment until disease progression, unacceptable toxicity, or withdrawal of consent.

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

Outcome Measures

Primary Outcome Measures :

1. Maximum tolerated dose [ Time Frame: 6 months ]
2. Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: 6 months ]

Secondary Outcome Measures :

1. Pharmacokinetics of SC-002 [ Time Frame: Cycle 1 and 4: days 1, 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 only ]
   Standard PK variables to be assessed include AUC, Tmax, Cmax, Ctrough, T1/2, CL, Vss
2. RECIST v1.1 assessed objective response rate [ Time Frame: 6 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Michigan

Ann Arbor, Michigan, United States, 48109

United States, Missouri

Saint Louis, Missouri, United States, 63110

United States, New York

New York, New York, United States, 10065

United States, Tennessee

Nashville, Tennessee, United States, 37203

Sponsors and Collaborators

Stemcentrx

Investigators

• Study Director: Julia Lawrence, D.O.; Novella Clinical

More Information

• Responsible Party: Stemcentrx
• ClinicalTrials.gov Identifier: NCT02500914
• Other Study ID Numbers: SCRX002-001
• First Posted: July 17, 2015
• Last Update Posted: October 5, 2018
• Last Verified: October 2018

Keywords provided by Stemcentrx:

small cell lung cancer

Additional relevant MeSH terms:

Lung Neoplasms; Small Cell Lung Carcinoma; Carcinoma, Neuroendocrine; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Adenocarcinoma; Neoplasms, Nerve Tissue