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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Stemcentrx
Sponsor:
Information provided by (Responsible Party):
Stemcentrx
ClinicalTrials.gov Identifier:
NCT02500914
First received: July 6, 2015
Last updated: June 24, 2016
Last verified: June 2016
  Purpose

This is a Phase 1a/1b study of SC-002 in patients with relapsed small cell lung cancer (SCLC) and 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 and LCNEC, to evaluate the side effects of SC-002, and to assess the anti-cancer activity of SC-002.


Condition Intervention Phase
Small Cell Lung Cancer
Large Cell Neuroendocrine Carcinoma
Drug: SC-002
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Stemcentrx:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

  • RECIST v1.1 assessed objective response rate [ Time Frame: 6 months ]

Estimated Enrollment: 102
Study Start Date: June 2015
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02500914

Contacts
Contact: Stemcentrx Study Team SCRX002-001@stemcentrx.com
Contact: John H M Mei john.mei@stemcentrx.com

Locations
United States, Missouri
Recruiting
St. Louis, Missouri, United States, 63110
United States, New York
Recruiting
New York, New York, United States, 10065
United States, Tennessee
Recruiting
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     History of Changes
Other Study ID Numbers: SCRX002-001
Study First Received: July 6, 2015
Last Updated: June 24, 2016

Keywords provided by Stemcentrx:
small cell lung cancer
large cell neuroendocrine carcinoma

Additional relevant MeSH terms:
Carcinoma
Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Neuroendocrine
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

ClinicalTrials.gov processed this record on March 28, 2017