A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours
← catalyst calendarNCT06147037 · readout in 134 d
Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →.
Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
13actual
Sites
8
Countries
Canada, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-07-31 | actual | When the study began enrolling |
| Primary completion | 2026-12-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2023-11-27 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-07 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Advanced Solid Tumor
- Metastatic Colorectal Carcinoma
- Head and Neck Squamous Cell Carcinoma
- Non-small Cell Lung Cancer
- Pancreatic Ductal Adenocarcinoma
- Gastric Cancer
- Renal Cell Carcinoma
Interventions
- Drug: FPI-2053
- Drug: [111In]-FPI-2107
- Drug: [225Ac]-FPI-2068
Primary outcomes
what the primary-completion date above is the date OFEvaluate safety and tolerability of [111In]-FPI-2107, FPI-2053, and [225Ac]-FPI-2068
measured From informed consent up to approximately 5 years post last administration
Determine radiation dose of [111In]-FPI-2107 and [225Ac]-FPI-2068 to whole body, organs, and selected regions of interest.
measured Within 56 days of administration
Determine the RP2D of [225Ac]-FPI-2068, given with or without FPI-2053
measured 56 days post administration
Determine the effect of predose administration of varying doses of FPI-2053 on the radiation dosimetry of [111In]-FPI-2107 and [225Ac]-FPI-2068 to whole body, organs, and selected regions of interest.
measured 56 days post-administration
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