SC-002 in Small Cell Lung Cancer and Large Cell Neuroendocrine Carcinoma
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
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|
- Maximum tolerated dose [ Time Frame: 6 months ]
- Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: 6 months ]
- 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 ]
|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)|
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.
SC-002 will be administered by IV infusion over approximately 30 minutes every 3 weeks
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02500914
|Contact: Stemcentrx Study Team||SCRX002email@example.com|
|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|
|Study Director:||Julia Lawrence, D.O.||Novella Clinical|