Clinical trial · Interventional
A Study of [225Ac]-FPI-2059 in Adult Participants With Solid Tumours
A Phase 1 Study of [225Ac]-FPI-2059 in Adult Participants With NTSR1-Expressing Advanced, Metastatic and/or Recurrent Solid Tumours
NCT05605522CI-TRIAL-00094049terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor reprioritization of active trials.
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Ewing Sarcoma | Ewing Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Neuroendocrine Differentiated (NED) Prostate Cancer | — | UNRESOLVED | — |
| NTSR1 Expressing Solid Tumours | — | UNRESOLVED | — |
| Pancreatic Ductal Adenocarcinoma (PDAC) | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.85 |
| Squamous Cell Carcinoma of Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [111In]-FPI-2058 | Drug | — | UNRESOLVED |
| [225]-FPI-2059 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase 1 Dose Escalation
- interventionNames
- Drug: [225]-FPI-2059
- Drug: [111In]-FPI-2058
- type
- EXPERIMENTAL
- label
- Phase 1 Dose Expansion
- interventionNames
- Drug: [225]-FPI-2059
- Drug: [111In]-FPI-2058
Primary outcomes (3)
- measure
- Incidence of Adverse Events to evaluate safety and tolerability of [225Ac]-FPI-2059 and [111In]-FPI-2058
- timeFrame
- approximately 5 years post final administration
- measure
- Maximum tolerated dose (MTD) of [225Ac]-FPI-2059
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Signed ICF prior to initiation of any study-specific procedures * Histologically and/or cytologically confirmed solid tumor that is metastatic or locally advanced, inoperable, or recurrent. Solid tumors indications may include PDAC, CRC, NED prostate cancer, gastric cancer, SCCHN, and Ewing sarcoma. * Disease that has progressed despite prior treatment, and for which additional effective standard therapy is not available or is contraindicated, not tolerable, or the patient refuses standard therapy * Measurable disease per RECIST v.1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Sufficient target expression in at least one measurable lesion as determined by imaging following injection of \[111In\]-FPI-2058 * Adequate organ function * Tumor tissue (either archival within the last 24 months or fresh biopsy) Key Exclusion Criteria: * Previous treatment with any radiopharmaceutical * Contraindications to or inability to perform the imaging procedures required in this study * Anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal therapy, targeted therapy, or investigational agents within certain amount of time prior to administration of the first dose of \[111In\]-FPI-2058 * Radiation therapy (RT) within 28 days prior to the first dose of \[111In\]-FPI-2058 * Patients with known CNS metastatic disease * Concurrent severe and/or uncontrolled illness that would limit compliance with study requirements * Known or suspected allergies or contraindication to the investigational treatment * Received any type of vaccine within 30 days prior to the first dose of \[111In\]-FPI-2058
References
Publications (0)
Data not yet available
No reference posted for this study.