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

NCT02500914 | Terminated Phase 1

• 1 other identifier: SCRX002-001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 4

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.

Conditions

Small Cell Lung Cancer

Keywords

small cell lung cancer

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose

  6 months

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

  6 months

Secondary Outcomes (2)

• Pharmacokinetics of SC-002

  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

  6 months

Study Arms (1)

SC-002

EXPERIMENTAL

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

Interventions

SC-002 DRUG

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

SC-002

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stemcentrx: lead

Study Sites (4)

Unknown Facility

Ann Arbor, Michigan, 48109, United States

Location

Unknown Facility

St Louis, Missouri, 63110, United States

Location

Unknown Facility

New York, New York, 10065, United States

Location

Unknown Facility

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

• Morgensztern D, Johnson M, Rudin CM, Rossi M, Lazarov M, Brickman D, Fong A. SC-002 in patients with relapsed or refractory small cell lung cancer and large cell neuroendocrine carcinoma: Phase 1 study. Lung Cancer. 2020 Jul;145:126-131. doi: 10.1016/j.lungcan.2020.04.017. Epub 2020 May 12.

  PMID: 32438272 DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

SC002

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Julia Lawrence, D.O.

  Novella Clinical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2015
• First Posted: July 17, 2015
• Study Start: June 1, 2015
• Primary Completion: August 23, 2018
• Study Completion: August 23, 2018
• Last Updated: October 5, 2018

Record last verified: 2018-10

Locations

US (4)