Clinical trial · Interventional
A Study of [225Ac]-FPI-1966 in Participants With Advanced Solid Tumours
A Phase 1/2 Study of [225Ac]-FPI-1966, [111In]-FPI-1967, and Vofatamab in Participants With FGFR3-expressing Advanced, Inoperable, Metastatic and/or Recurrent Solid Tumours
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Fusion announced that it is discontinuing this study as part of a portfolio prioritization and assessment; Fusion no longer plans to pursue development of FPI-1966.
Summary
Brief summary (as posted)
This first-in-human study evaluates safety, tolerability and distribution of \[225Ac\] FPI-1966, \[111In\]-FPI-1967, and vofatamab in patients with FGFR3-expressing solid tumors.
Conditions
Conditions (14)
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 |
| Bladder Carcinoma | Bladder Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| FGFR3 | — | UNRESOLVED | — |
| FGFR3 Overexpression | — | UNRESOLVED | — |
| FGFR3 Protein Overexpression | — | UNRESOLVED | — |
| FGFR3 Receptor | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [111In]-FPI-1967 | Drug | — | UNRESOLVED |
| [225Ac]-FPI-1966 | Drug | — | UNRESOLVED |
| vofatamab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase 1
- description
- Depending on assigned cohort, \[In111\]-FPI-1967/\[225Ac\]-FPI-1966 will be administered with or without pre-dosing with vofatamab.
- interventionNames
- Drug: [225Ac]-FPI-1966
- Drug: [111In]-FPI-1967
- Biological: vofatamab
- type
- EXPERIMENTAL
- label
- Phase 2
- description
- Depending on assigned cohort, \[In111\]-FPI-1967/\[225Ac\]-FPI-1966 will be administered either with or without pre-administration of vofatamab, depending on the RP2D/regimen as determined in the phase 1 portion of the study.
- interventionNames
- Drug: [225Ac]-FPI-1966
- Drug: [111In]-FPI-1967
- Biological: vofatamab
Primary outcomes (5)
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 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Histologically and/or cytologically documented diagnosis of locally advanced, inoperable, or metastatic solid tumours * Refractory to all standard treatments, or for whom standard treatment is not available, or tolerable, or is contraindicated, or the participant refuses standard therapy * Measurable disease per RECIST v. 1.1 * Available tumour tissue (archival or fresh biopsy) * Adequate bone marrow, heart, liver, and kidney function Key Exclusion Criteria: * Prior systemic radiopharmaceutical therapy within six months prior to the first dose of \[111In\]-FPI-1967 * Prior radiation therapy (RT) to bone marrow \> 20 Gy * RT within 30 days prior to the first dose of \[111In\]-FPI-1967 * Prior anti-cancer treatment (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, or investigational agents) within a certain amount of time prior to administration of the first dose of \[111In\]-FPI-1967 * Concurrent serious co-morbidities that could limit participants' full participation and compliance
References
Publications (0)
Data not yet available