Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0UUEEH
ADC Name
SC-002
Synonyms
SC-002; SC002; SC 002
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Organization
Stemcentrx, Inc.; AbbVie, Inc.
Drug Status
Phase 1
Indication
In total 1 Indication(s)
Small cell lung cancer [ICD11:2C25]
Phase 1
Drug-to-Antibody Ratio
2
Antibody Name
Rovalpituzumab
  Antibody Info 
Antigen Name
Delta-like protein 3 (DLL3)
  Antigen Info 
Payload Name
SG3199
  Payload Info 
Therapeutic Target
Human Deoxyribonucleic acid (hDNA)
  Target Info 
Linker Name
Vali-Ala dipeptide linker
  Linker Info 
Conjugate Type
Site-specific conjugation through the cysteine.
TTD ID
D0D4OL
ChEBI ID
CHEMBL3990011
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 2 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Objective Response Rate (ORR)  NCT02500914
Phase 1a/1b
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.
Undisclosed  NCT02500914
Phase 1
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.
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 2 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Efficacy Data Objective Response Rate (ORR)
14.29%
Patients Enrolled
Small-cell lung cancer (either limited or extensive disease) or large cell neuroendocrine carcinoma that had relapsed or was refractory to treatment following 1 prior systemic chemotherapy and for which no curative therapy was available were eligible for the phase 1a dose-escalation.
Administration Dosage
7 dose levels (0.025-0.40 mg/kg), 3+3 design.
Related Clinical Trial
NCT Number NCT02500914  Clinical Status Phase 1a/1b
Clinical Description 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.
Primary Endpoint
All patients (N = 35) were included in response analyses. Five patients (14.29%) overall achieved a PR per investigator assessment,with no patients achieving a CR. One patient each had a PR in the 0.20 and 0.30 mg/kg Q3W dose groups, and 3 patients in the 0.40 mg/kg Q9W dose group, fourteen (40.00%) patients achieved stable disease as their best overall response,and 5 had no or an non-evaluable posttreatment scan.

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Other Endpoint
Nineteen patients had tumor samples that were able to be assessed for DLL3 expression by immunohistochemistry. DLL3-positive expression by immunohistochemistry (DLL3 >0%) was confirmed in 17 patients; 5 were DLL3 high (75.00% DLL3 positive cells). Of DLL3-positive patients, 2 (11.80%) achieved a PR, including 1 patient in the 0.20 mg/kg Q3W cohort and 1 DLL3-high patient in the 0.40 mg/kg Q9W cohort.

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Experiment 2 Reporting the Activity Date of This ADC [2]
Related Clinical Trial
NCT Number NCT02500914  Clinical Status Phase 1
Clinical Description 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.
References
Ref 1 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.
Ref 2 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, NCT02500914

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