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A Phase 2 diagnostic study with 68Ga-EVG321 in Patients with Small Cell Lung Cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514584-25-00
Acronym
EVG001AD201
Enrollment
23
Registered
2024-10-10
Start date
2024-12-16
Completion date
Unknown
Last updated
2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Cell Lung Cancer

Brief summary

Quantitative measurements of 68Ga-EVG321 radioactivity in volumes of interest (VOIs) from whole-body images over target organs will be made at several time points

Detailed description

Safety and tolerability, including treatment emergent adverse events and pre/post-68Ga-EVG321 PET/CT lab values, ECGs and vital signs, Pharmacokinetic parameters [e.g., Cmax, area under the curve (AUC), total clearance (CL), steady-state volume of distribution (Vss) and mean residence time (MRT)] of 68Ga- EVG321 in both healthy tissues and primary/metastatic lesions, Comparison of 68Ga-EVG321 PET/CT imaging to determine the presence of CCK2R expressing SCLC relative to histopathology

Interventions

None listed

Sponsors

Evergreen Theragnostics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Quantitative measurements of 68Ga-EVG321 radioactivity in volumes of interest (VOIs) from whole-body images over target organs will be made at several time points

Secondary

MeasureTime frame
Safety and tolerability, including treatment emergent adverse events and pre/post-68Ga-EVG321 PET/CT lab values, ECGs and vital signs, Pharmacokinetic parameters [e.g., Cmax, area under the curve (AUC), total clearance (CL), steady-state volume of distribution (Vss) and mean residence time (MRT)] of 68Ga- EVG321 in both healthy tissues and primary/metastatic lesions, Comparison of 68Ga-EVG321 PET/CT imaging to determine the presence of CCK2R expressing SCLC relative to histopathology

Countries

Austria, Germany, Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026