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ZG006 in Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma
NCT06283719Phase 2
Key facts
- Status
- Recruiting
- Start
- Sep 2024
- Primary completion
- Apr 2027
- Countries
- 1
- Sponsor
- Zelgen
- Modality
- Trispecific Antibodies, T-cell Engagers
- Drugs
- alveltamig
- Conditions
- small cell lung cancer (SCLC)neuroendocrine carcinoma (NEC)
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Overview
Phase 2, open-label trial of alveltamig in small cell lung cancer (SCLC) and neuroendocrine carcinoma (NEC) (2 arms), sponsored by Zelgen. Primary endpoints: Objective response rate at 2 years and Overall Survival at 3 years. Started Sep 2024; status: recruiting.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Part1 :Dose Escalation
A total of six dose escalations were preset: 0.1 mg, 0.3 mg, 1 mg, 3 mg, 10 mg, and 30 mg.
Part2 :Dose Expansion
Part 2 consists of three cohorts. Cohort 1 is divided into two stages: Stage 1 for dose optimization and Stage 2 as a pivotal registrational study.
03
Who it enrols
Adults aged 18-75 with advanced small-cell lung cancer or neuroendocrine carcinoma, ECOG 0-1, and life expectancy >= 3 months. Part 2 Stage 2 requires third-line or later therapy.
04
Endpoints
Primary
Objective response rate
Overall Survival
Secondary
Adverse Events
Serious Adverse Events
Duration of response
Disease control rate
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