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NCT06147037

A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
AstraZeneca
~13 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:FPI-2053[111In]-FPI-2107[225Ac]-FPI-2068

At a glance

Recruiting sites
0 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate safety and tolerability of [111In]-FPI-2107, FPI-2053, and [225Ac]-FPI-2068
Measured over From informed consent up to approximately 5 years post last administration
+3 more outcomes measured

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

Explore related trials

Colorectal CarcinomaGastric CarcinomaHead and Neck Squamous Cell CarcinomaLung Non-Small Cell CarcinomaPancreatic CarcinomaRenal Cell CarcinomaSolid Neoplasm

Where it's being run

8 sites across 7 states
Quebec2
California1
Illinois1
Nebraska1
Ohio1
Texas1
Washington1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

What this trial measures

  • Evaluate safety and tolerability of [111In]-FPI-2107, FPI-2053, and [225Ac]-FPI-2068From informed consent up to approximately 5 years post last administration

    Frequency, duration, and severity of AEs, DLTs, and changes in clinical, laboratory, and ECG parameters compared to baseline

  • Determine radiation dose of [111In]-FPI-2107 and [225Ac]-FPI-2068 to whole body, organs, and selected regions of interest.Within 56 days of administration

    Changes in uptake of \[111In\]-FPI-2107 and projected RAD of \[225Ac\]-FPI-2068 by imaging following the administration of varying doses of FPI-2053

  • Determine the RP2D of [225Ac]-FPI-2068, given with or without FPI-205356 days post administration

    Estimates of residence time and absorbed radiation doses to the whole body, organs, and selected regions of interest for \[111In\]-FPI-2107 and \[225Ac\]-FPI-2068.

  • 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.56 days post-administration

    Changes in uptake of \[111In\]-FPI- 2107 and projected RAD of \[225Ac\]-FPI-2068 by imaging following the administration of varying doses of FPI-2053