A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients with Advanced Solid Tumours
Study identifier:FPI-2068-101
ClinicalTrials.gov identifier:NCT06147037
EudraCT identifier:N/A
CTIS identifier:N/A
Recruiting
Official Title
A Phase 1, First-in-human, Multicentre, Open-label, Dose escalation Study of [225Ac]-FPI-2068 in Adult Patients with Advanced Solid Tumours
Medical condition
advanced solid tumor, Metastatic Colorectal Carcinoma
Phase
Phase 1
Healthy volunteers
No
Study drug
FPI-2053, [111In]-FPI-2107, [225Ac]-FPI-2068
Sex
All
Estimated Enrollment
70
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 31 Jul 2024
Estimated Primary Completion Date: 12 May 2028
Estimated Study Completion Date: 12 May 2028
Study design
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2025 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
AstraZeneca
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: Dose Exploration and Dose Escalation The study conducted in two parts: Part A Dose Exploration and Part B Dose Escalation FPI-2053 dose exploration to determine the optimal pre-dose administration of FPI-2053 with a fixed dose of [225Ac]-FPI-2068. [225Ac]-FPI-2068 dose escalation with the optimal dose of FPI-2053 as determined in Part A. | - |
