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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02500914
Recruitment Status : Terminated (Strategic Considerations)
First Posted : July 17, 2015
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Stemcentrx

Tracking Information
First Submitted Date  ICMJE July 6, 2015
First Posted Date  ICMJE July 17, 2015
Last Update Posted Date October 5, 2018
Study Start Date  ICMJE June 2015
Actual Primary Completion Date August 23, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2015)
  • Maximum tolerated dose [ Time Frame: 6 months ]
  • Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SC-002 in Small Cell Lung Cancer and Large Cell Neuroendocrine Carcinoma
Official Title  ICMJE 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
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Small Cell Lung Cancer
Intervention  ICMJE Drug: SC-002
SC-002 will be administered by IV infusion over approximately 30 minutes every 3 weeks
Study Arms  ICMJE 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.

Intervention: Drug: SC-002
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 3, 2018)
35
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2015)
102
Actual Study Completion Date  ICMJE August 23, 2018
Actual Primary Completion Date August 23, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02500914
Other Study ID Numbers  ICMJE SCRX002-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Stemcentrx
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Stemcentrx
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Julia Lawrence, D.O. Novella Clinical
PRS Account Stemcentrx
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP