SC16LD6.5 in Recurrent Small Cell Lung Cancer

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. Identifier: NCT01901653
Recruitment Status : Completed
First Posted : July 17, 2013
Last Update Posted : April 25, 2017
Information provided by (Responsible Party):

July 11, 2013
July 17, 2013
April 25, 2017
July 2013
January 2017   (Final data collection date for primary outcome measure)
  • Maximum Tolerated Dose [ Time Frame: 6 months ]
  • RECIST v1.1 Assessed Objective Response Rate [ Time Frame: 18 months ]
Same as current
Complete list of historical versions of study NCT01901653 on Archive Site
  • Pharmacokinetics of SC16LD6.5 [ Time Frame: 18 months ]
    Standard PK variables, including Cmax, AUC, Vd, CL, and T1/2, will be assessed for SC16LD6.5, SC16, and D6.5
  • RECIST v1.1 Assessed Progression Free Survival [ Time Frame: 18 months ]
  • Overall Survival [ Time Frame: 24 months ]
Same as current
Not Provided
Not Provided
SC16LD6.5 in Recurrent Small Cell Lung Cancer
Phase I/II Open Label Dose Escalation Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of SC16LD6.5 as a Single Agent in Patients With Recurrent Small Cell Lung Cancer
The purpose of this study is to assess the safety and tolerability of SC16LD6.5 at different dose levels in patients with small cell lung cancer whose cancer has progressed or recurred following standard chemotherapy. Once a safe and tolerable dose is determined, the anti-cancer activity of SC16LD6.5 will be assessed by measuring the extent of tumor shrinkage. SC16LD6.5 is an antibody-drug conjugate (ADC). The antibody (SC16) targets a protein that appears to be expressed on the surface of most small cell lung cancers that have been assessed using an immunohistochemical assay. The drug, D6.5, is a very potent form of chemotherapy, specifically a DNA-damaging agent, that is cell cycle independent. ADC's theoretically provide more precise delivery of chemotherapy to cancer cells, possibly improving effectiveness relative to toxicities.
Not Provided
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Recurrent Small Cell Lung Cancer
Drug: SC16LD6.5
Experimental: SC16LD6.5
SC16LD6.5 will be administered as a single agent, at increasing dose levels as permitted based on real-time assessment of safety and tolerability, intravenously over 30 minutes. Doses will be repeated every 3 weeks until either unacceptable toxicity or evidence of disease progression occurs.
Intervention: Drug: SC16LD6.5
Rudin CM, Pietanza MC, Bauer TM, Ready N, Morgensztern D, Glisson BS, Byers LA, Johnson ML, Burris HA 3rd, Robert F, Han TH, Bheddah S, Theiss N, Watson S, Mathur D, Vennapusa B, Zayed H, Lally S, Strickland DK, Govindan R, Dylla SJ, Peng SL, Spigel DR; SCRX16-001 investigators. Rovalpituzumab tesirine, a DLL3-targeted antibody-drug conjugate, in recurrent small-cell lung cancer: a first-in-human, first-in-class, open-label, phase 1 study. Lancet Oncol. 2017 Jan;18(1):42-51. doi: 10.1016/S1470-2045(16)30565-4. Epub 2016 Dec 5.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2017
January 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria

  1. Provision of informed consent
  2. Male or female ≥18 years of age
  3. Histologic or cytologic confirmed diagnosis of small cell lung cancer, either limited or extensive disease at initial presentation is allowed
  4. Evidence of progressive disease during or following 1 or 2 prior chemotherapy regimens

    • At least 1 prior regimen must have contained a platinum salt
    • 'Adjuvant therapy' will constitute a prior treatment regimen
    • No more than 2 prior regimens are allowed
  5. Measurable disease (only for the phase II portion)
  6. ECOG Performance status 0-1
  7. A minimum life expectancy of 12 weeks
  8. Adequate bone marrow, hepatic and renal function as evidenced by:

    • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    • Platelet count ≥ 100 x 109/L
    • Hemoglobin ≥ 9.0 g/dL
    • Serum bilirubin < 1.5 x ULN
    • AST/ALT (SGOT/SGPT) < 2.5 x ULN for the reference laboratory or < 5 x ULN in the presence of liver metastases
    • Serum creatinine < 1.5 x ULN
  9. No 'active' CNS metastases. Prior CNS metastases are allowed, provided adequate palliative therapy has been administered and CNS disease control has been established prior to study entry.

    • A brain MRI scan, ≤ 28 days from day 1, is required

  10. Female patients who are not of child-bearing potential, and female patients of child-bearing potential who agree to use adequate contraceptive measures and who have a negative serum pregnancy test within 1 week prior to initial study treatment. (See Appendix B)
  11. Male patients willing to use adequate contraceptive. (See Appendix B)
  12. At least 21 days must have elapsed prior to day 1 cycle 1, from chemotherapy, radiotherapy, immunotherapy or following major surgery and any surgical incision should be completely healed. At least 14 days must have elapsed prior to Day 1 Cycle 1 for "limited palliative radiotherapy", defined as a course of therapy encompassing < 25% total bone marrow volume and not exceeding 30 Gy.
  13. At least 14 days must have elapsed for chemotherapy regimens, biologic, and targeted therapy given continuously or on a weekly basis with limited potential for delayed toxicity.

Exclusion Criteria:

  1. Patients who are pregnant or breastfeeding.
  2. Active involvement of the Central Nervous System (CNS).
  3. Uncontrolled infection or systemic disease.
  4. Clinically significant cardiac disease not well controlled with medication (e.g., congestive heart failure, symptomatic coronary artery disease e.g. angina, and cardiac arrhythmias) or myocardial infarction within the last 12 months.
  5. Chemotherapy regimens within the last 21 days (or within 6 weeks for prior nitrosourea or mitomycin C). Chemotherapy regimens, biologic, and targeted therapy given continuously or on a weekly basis with limited potential for delayed toxicity within the last 14 days.
  6. No concurrent systemic chemotherapy or anticancer biologic therapy is allowed. Note: Patients on hormonal treatment for breast cancer or prostate cancer may continue on treatment and enter into study.
  7. Known hypersensitivity to any components of SC16LD6.5 study drug product.
  8. Patients with known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously treated or both), a history of solid organ or bone marrow transplantation would generally be considered to have met exclusion criteria, however exceptions may be considered on a case-by-case basis by the medical monitor.
  9. Psychiatric disorder or social or geographic situation that would preclude study participation.
  10. QTcF interval of >450 msec (males) or >470 msec (females)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Study Director: Donald Strickland, MD SCRI Innovations
April 2017

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