- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02500914
SC-002 in Small Cell Lung Cancer and Large Cell Neuroendocrine Carcinoma
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
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 Overview
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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
-
-
New York
-
New York, New York, United States, 10065
-
-
Tennessee
-
Nashville, Tennessee, United States, 37203
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
SC-002 will be administered by IV infusion over approximately 30 minutes every 3 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum tolerated dose
Time Frame: 6 months
|
6 months
|
Number of subjects with adverse events as a measure of safety and tolerability
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Cycle 1 and 4: days 1, 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 only
|
RECIST v1.1 assessed objective response rate
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Julia Lawrence, D.O., Novella Clinical
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Carcinoma, Neuroendocrine
Other Study ID Numbers
- SCRX002-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Small Cell Lung Cancer
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
-
AIO-Studien-gGmbHBristol-Myers Squibb; Eli Lilly and Company; Merck Sharp & Dohme LLC; Pfizer; Gilead... and other collaboratorsRecruitingSmall-cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage I | Metastatic Non-small Cell Lung Cancer (NSCLC) | Non Small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer Stage IIGermany
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
-
University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
-
National Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung CancerUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedTobacco Use Disorder | Stage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Limited Stage Small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB...United States
-
Washington University School of MedicineMerck Sharp & Dohme LLCWithdrawnNSCLC | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Small Cell Lung Extensive Stage
-
Shanghai Chest HospitalRecruitingSmall Cell Lung Carcinoma | Small-cell Lung Cancer | Small Cell Lung Cancer Limited Stage | Small Cell Lung Cancer Extensive Stage | Small Cell Lung Cancer, Combined TypeChina
-
Alexander ChiNot yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Carcinoma | Non-small Cell Lung Cancer Stage IIChina
-
National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
Clinical Trials on SC-002
-
Avalo Therapeutics, Inc.CompletedNon-Eosinophilic AsthmaUnited States
-
Aevi Genomic Medicine, LLC, a Cerecor companyCompletedAcute Lung Injury | ARDS | COVID-19 PneumoniaUnited States
-
Avalo Therapeutics, Inc.TerminatedCrohn Disease | Ulcerative ColitisUnited States
-
Vyluma, Inc.Syneos HealthActive, not recruitingMyopiaUnited States, Hungary, Ireland, Netherlands, Spain, United Kingdom
-
BiocadRecruitingStudy of the Safety, Pharmacodynamics and Efficacy of ANB-002 in Patients With Hemophilia B (SAFRAN)Hemophilia BRussian Federation
-
PMG Pharm Co., LtdRecruitingKnee OsteoarthritisKorea, Republic of
-
ImmuneOncia Therapeutics Inc.CompletedLymphoma | Solid TumorKorea, Republic of, United States
-
Orion Biotechnology Polska Sp. z o.o.Not yet recruitingMetastatic Colorectal Cancer | Metastatic Cancer | Metastatic Breast Cancer | Metastatic Urothelial Carcinoma | Metastatic Gastric Cancer | Metastatic Pancreatic Cancer
-
Kinaset Therapeutics IncActive, not recruiting
-
Codiak BioSciencesCompletedAdvanced Solid TumorUnited States, United Kingdom