Status:
TERMINATED
A Study of [225Ac]-FPI-1966 in Participants With Advanced Solid Tumours
Lead Sponsor:
Fusion Pharmaceuticals Inc.
Conditions:
Advanced Solid Tumor
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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.
Detailed Description
In phase 1, cohort 1, the potential impact of pre-dose administration of vofatamab on the dosimetry, PK, safety, and tolerability of \[225Ac\]-FPI-1966 and \[111In\]-FPI-1967 will be evaluated. In la...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
April 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05363605
Start Date
April 20 2022
End Date
September 8 2023
Last Update
December 19 2023
Active Locations (6)
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1
City of Hope
Duarte, California, United States, 91010
2
University of California, San Francisco
San Francisco, California, United States, 94143
3
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065