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A Study of [225Ac]-FPI-2059 in Adult Participants With Solid Tumours

NCT05605522 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-08-24

No results posted yet for this study

Summary

This is a first-in-human Phase 1 clinical trial designed to investigate the safety, tolerability, pharmacokinetics, and biodistribution of \[225Ac\]-FPI-2059 and \[111In\]-FPI-2058 in participants with neurotensin receptor 1 (NTSR1)-expressing solid tumours.

Conditions

  • Pancreatic Ductal Adenocarcinoma (PDAC)
  • Squamous Cell Carcinoma of Head and Neck
  • Colorectal Cancer
  • Gastric Cancer
  • Ewing Sarcoma
  • NTSR1 Expressing Solid Tumours
  • Neuroendocrine Differentiated (NED) Prostate Cancer

Interventions

DRUG

[225]-FPI-2059

\[225Ac\]-FPI-2059 is a targeted alpha therapeutic that consists of an NTSR1-targeting small molecule that is linked to Ac-225, an alpha particle emitting radionuclide. Participants will be dosed through IV administration every 56 days up to four cycles. The dose depends on cohort assignment. In the Dose Expansion arm, \[225Ac\]-FPI-2059 will be administered at the RP2D as determined in Phase 1 Dose Escalation.

DRUG

[111In]-FPI-2058

\[111In\]-FPI-2058 is an imaging agent that consists of an NTSR1-targeting small molecule linked to In-111.Participants will receive \[111In\]-FPI-2058 by IV Injection for imaging once during screening period. The dose is consistent across cohorts.

Sponsors & Collaborators

  • 3B Pharmaceuticals GmbH

    lead INDUSTRY

Principal Investigators

  • Aaron Enke · 3B Pharmaceuticals GmbH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-07
Primary Completion
2024-07-19
Completion
2025-02-20
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05605522 on ClinicalTrials.gov