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SC-002 in patients with relapsed or refractory small cell lung cancer and large cell neuroendocrine carcinoma: Phase
Daniel Morgensztern1, Melissa Johnson2, Charles M Rudin3
1Washington University School of Medicine, St. Louis, MO, USA.
Objectives:
This phase 1 study investigated safety/tolerability, pharmacokinetics, and preliminary efficacy of SC-002, a delta-like ligand 3-directed antibody-drug conjugate, in advanced small cell lung cancer and large cell neuroendocrine carcinoma.
Materials And Methods:
Eligible patients received SC-002 at 1 of 7 dose levels during the dose-escalation portion of the study.
Results:
Thirty-five enrolled patients received ≥1 dose of SC-002. Twenty-three (66%) patients experienced serious adverse events (AEs), 37% considered related to SC-002. Grade 3/4 AEs occurred in 21 (60%) and 2 (6%) patients; the most common were effusion and hypoalbuminemia. One grade 5 AE occurred in 1 patient. Five (14%) patients achieved a partial response and no patients achieved a complete response.
Conclusion:
SC-002 treatment was associated with systemic toxicity and limited efficacy.
Insights
This phase 1 trial of SC-002, a delta-like ligand 3-directed antibody-drug conjugate, showed significant toxicity and limited effectiveness in advanced neuroendocrine cancers.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Neuroendocrine tumors, including small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC), represent aggressive malignancies.
- Novel therapeutic strategies targeting specific molecular pathways are needed for these difficult-to-treat cancers.
Purpose of the Study:
- To evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of SC-002, an antibody-drug conjugate targeting delta-like ligand 3 (DLL3).
- To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of SC-002 in patients with advanced SCLC and LCNEC.
Main Methods:
- A phase 1, dose-escalation study was conducted in patients with advanced SCLC or LCNEC.
- Patients received SC-002 at one of seven dose levels.
- Safety, tolerability, pharmacokinetics, and preliminary response were assessed.
Main Results:
- Thirty-five patients were enrolled and received SC-002.
- Serious adverse events (SAEs) were reported in 66% of patients, with 37% considered related to SC-002.
- Grade 3/4 adverse events included effusion (60%) and hypoalbuminemia (6%).
- Five patients (14%) achieved a partial response; no complete responses were observed.
Conclusions:
- SC-002 treatment was associated with significant systemic toxicity in patients with advanced neuroendocrine carcinomas.
- The preliminary efficacy observed was limited, suggesting a need for further investigation or combination strategies.
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