Clinical trial · Interventional
A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours
A Phase 1, First-in-human, Multicentre, Open-label, Dose Escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours
NCT06147037CI-TRIAL-00117090active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a first-in-human, Phase 1, non-randomized, multicenter, open-label clinical study designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics (PK) of \[225Ac\]-FPI-2068, \[111In\]-FPI-2107, and FPI-2053 in metastatic and/or recurrent solid tumors (HNSCC, NSCLC, mCRC, PDAC, GC, RCC).
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 |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Metastatic Colorectal Carcinoma | Colorectal Carcinoma | CURATED_BROADER | 0.78 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [111In]-FPI-2107 | Drug | — | UNRESOLVED |
| [225Ac]-FPI-2068 | Drug | — | UNRESOLVED |
| FPI-2053 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Exploration and Dose Escalation
- description
- 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.
- interventionNames
- Drug: FPI-2053
- Drug: [111In]-FPI-2107
- Drug: [225Ac]-FPI-2068
Primary outcomes (4)
- measure
- Evaluate safety and tolerability of [111In]-FPI-2107, FPI-2053, and [225Ac]-FPI-2068
- timeFrame
- From informed consent up to approximately 5 years post last administration
- description
- Frequency, duration, and severity of AEs, DLTs, and changes in clinical, laboratory, and ECG parameters compared to baseline
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
Key Inclusion Criteria: Histologically and/or cytologically confirmed solid tumor that is metastatic, locally advanced, recurrent or inoperable. Disease that has progressed despite prior treatment, and for which additional effective standard therapy is not available or is contraindicated, not tolerable, or the participant refuses standard therapy. Measurable disease as defined by RECIST Version 1.1 ECOG Performance status of 0 or 1 Adequate organ function Key Exclusion Criteria: Previous treatment with any systemic radiopharmaceutical Prior anti-cancer therapy unless adequate washout and recovery from toxicities Contraindications to or inability to perform the imaging procedures required in this study Radiation therapy (RT) within 28 days prior to the first dose of \[111In\]-FPI-2107 Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (≥ once per month) Patients with known CNS metastatic disease unless treated and stable
References
Publications (0)
Data not yet available
No reference posted for this study.