A Study of [225Ac]-FPI-1966 in Participants With Advanced Solid Tumours
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.
Checked against the public recordLast updated Dec 19, 2023 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Fusion Pharmaceuticals Inc.
- Interventions being studied
- Drug: [225Ac]-FPI-1966; Drug: [111In]-FPI-1967; Biological: vofatamab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- City of HopeDuarte, California
- University of California, San FranciscoSan Francisco, California
- University of Iowa Hospitals and ClinicsIowa City, Iowa
- Memorial Sloan Kettering Cancer CenterNew York, New York
- GC MurdochMurdoch, Western Australia
- St Vincent's HospitalMelbourne
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 19, 2023. Always confirm current availability with the study team.