Back to resultsSC-002 in Small Cell Lung Cancer and Large Cell Neuroendocrine Carcinoma
Primary Purpose
Small Cell Lung Cancer
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SC-002
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring small cell lung cancer
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SC-002
Arm Description
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.
Outcomes
Primary Outcome Measures
Maximum tolerated dose
Number of subjects with adverse events as a measure of safety and tolerability
Secondary Outcome Measures
Pharmacokinetics of SC-002
Standard PK variables to be assessed include AUC, Tmax, Cmax, Ctrough, T1/2, CL, Vss
RECIST v1.1 assessed objective response rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02500914
Brief Title
SC-002 in Small Cell Lung Cancer and Large Cell Neuroendocrine Carcinoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Strategic Considerations
Study Start Date
June 2015 (undefined)
Primary Completion Date
August 23, 2018 (Actual)
Study Completion Date
August 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stemcentrx
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
small cell lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SC-002
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
SC-002
Intervention Description
SC-002 will be administered by IV infusion over approximately 30 minutes every 3 weeks
Primary Outcome Measure Information:
Title
Maximum tolerated dose
Time Frame
6 months
Title
Number of subjects with adverse events as a measure of safety and tolerability
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Pharmacokinetics of SC-002
Description
Standard PK variables to be assessed include AUC, Tmax, Cmax, Ctrough, T1/2, CL, Vss
Time Frame
Cycle 1 and 4: days 1, 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 only
Title
RECIST v1.1 assessed objective response rate
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Lawrence, D.O.
Organizational Affiliation
Novella Clinical
Official's Role
Study Director
Facility Information:
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32438272
Citation
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.
Results Reference
derived
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SC-002 in Small Cell Lung Cancer and Large Cell Neuroendocrine Carcinoma
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