Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Strategic Considerations
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SC-002 | Drug | Rovalpituzumab Tesirine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SC-002
- 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.
- interventionNames
- Drug: SC-002
Primary outcomes (2)
- measure
- Maximum tolerated dose
- timeFrame
- 6 months
- measure
- Number of subjects with adverse events as a measure of safety and tolerability
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMorgensztern 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. PMID 32438272