Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ID: DRG0UUEEH)
ADC Name
SC-002
Synonyms
SC-002
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Organization
Stemcentrx (Top20 MNC) (Originator)
Drug Status
Phase 1 (discontinued)
Drug-to-Antibody Ratio
2
Antibody Name
Rovalpituzumab
  Antibody Info 
Antigen Name
Delta-like protein 3 (DLL3)
  Antigen Info 
Payload Name
SG3199 (SC-DR002)
  Payload Info 
Payload Target
Human deoxyribonucleic acid (hDNA)
  Target Info 
Linker Name
Val-Ala dipeptide linker
  Linker Info 
Conjugate Type
Reactive Cysteines
2027 Update
The disease landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
Disease Name Phase 1 Phase 2 Phase 3 Approved
Lung cancer
1 Trials
Clinical trial identifier
NCT02500914
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 3 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Undisclosed  NCT02500914
PHASE1
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
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 3 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Patients Enrolled
Eligible patients must have histologically confirmed relapsed/refractory SCLC or LCNEC (≤2 prior regimens), measurable disease by RECIST, ECOG 0-1, and adequate organ function. Key exclusions include active CNS metastases, uncontrolled cardiac disease, hepatitis/HIV infection, or conditions compromising study integrity.
Administration Dosage
SC-002 will be administered by IV infusion over approximately 30 minutes every 3 weeks
Related Clinical Trial
NCT Number NCT02500914  Clinical Status PHASE1
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
The study evaluates maximum tolerated dose and safety profile (adverse event incidence) over a 6-month period to establish the therapeutic window of SC-002.
Other Endpoint
Pharmacokinetic analysis of SC-002 includes comprehensive assessment of AUC, Tmax, Cmax, Ctrough, T1/2, CL, and Vss during treatment cycles, with tumor response measured by RECIST v1.1 criteria at 6 months.
Experiment 2 Reporting the Activity Date of This ADC [2]
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 3 Reporting the Activity Date of This ADC [3]
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 Small Cell Lung Cancer and Large Cell Neuroendocrine Carcinoma
Ref 2 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 3 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