A Study of [225Ac]-FPI-1966 in Participants With Advanced Solid Tumours
NCT ID: NCT05363605
Last Updated: 2023-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
6 participants
INTERVENTIONAL
2022-04-20
2023-09-08
Brief Summary
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Detailed Description
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In later phase 1 cohorts, \[225Ac\]-FPI-1966 will be evaluated at ascending dose levels. Participants will receive \[111In\]-FPI-1967 during the imaging screening period to assess FGFR3 expression and to determine biodistribution and estimate radiation exposure to critical organs.
Once the recommended phase 2 dose (RP2D) or regimen is established and confirmed, three tumour-agnostic expansion cohorts may be initiated in parallel.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1
Depending on assigned cohort, \[In111\]-FPI-1967/\[225Ac\]-FPI-1966 will be administered with or without pre-dosing with vofatamab.
[225Ac]-FPI-1966
\[225Ac\]-FPI-1966 is a targeted alpha therapeutic that consists of vofatamab, a bifunctional chelate, and actinium-225, an alpha particle emitting radionuclide. In Phase 1, the dose depends on cohort assignment. In Phase 2, the RP2D regimen will be administered.
[111In]-FPI-1967
\[111In\]-FPI-1967 is an imaging agent that consists of vofatamab, a bifunctional chelate and indium-111 radionuclide. Participants will receive \[111In\]-FPI-1967 Injection of 185 MBq for imaging.
vofatamab
Vofatamab is a Fibroblast Growth Factor Receptor 3 (FGFR3)-targeting human monoclonal antibody without a radioisotope. In Phase 1, the dose depends on cohort assignment. In Phase 2, if pre-dosing with vofatamab is indicated, the RP2D regimen will be administered.
Phase 2
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.
[225Ac]-FPI-1966
\[225Ac\]-FPI-1966 is a targeted alpha therapeutic that consists of vofatamab, a bifunctional chelate, and actinium-225, an alpha particle emitting radionuclide. In Phase 1, the dose depends on cohort assignment. In Phase 2, the RP2D regimen will be administered.
[111In]-FPI-1967
\[111In\]-FPI-1967 is an imaging agent that consists of vofatamab, a bifunctional chelate and indium-111 radionuclide. Participants will receive \[111In\]-FPI-1967 Injection of 185 MBq for imaging.
vofatamab
Vofatamab is a Fibroblast Growth Factor Receptor 3 (FGFR3)-targeting human monoclonal antibody without a radioisotope. In Phase 1, the dose depends on cohort assignment. In Phase 2, if pre-dosing with vofatamab is indicated, the RP2D regimen will be administered.
Interventions
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[225Ac]-FPI-1966
\[225Ac\]-FPI-1966 is a targeted alpha therapeutic that consists of vofatamab, a bifunctional chelate, and actinium-225, an alpha particle emitting radionuclide. In Phase 1, the dose depends on cohort assignment. In Phase 2, the RP2D regimen will be administered.
[111In]-FPI-1967
\[111In\]-FPI-1967 is an imaging agent that consists of vofatamab, a bifunctional chelate and indium-111 radionuclide. Participants will receive \[111In\]-FPI-1967 Injection of 185 MBq for imaging.
vofatamab
Vofatamab is a Fibroblast Growth Factor Receptor 3 (FGFR3)-targeting human monoclonal antibody without a radioisotope. In Phase 1, the dose depends on cohort assignment. In Phase 2, if pre-dosing with vofatamab is indicated, the RP2D regimen will be administered.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Fusion Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Julia Kazakin, MD
Role: STUDY_DIRECTOR
Fusion Pharmaceuticals Inc.
Locations
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City of Hope
Duarte, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
GC Murdoch
Murdoch, Western Australia, Australia
St Vincent's Hospital
Melbourne, , Australia
Countries
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Related Links
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Sponsor website
Other Identifiers
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FPI-1966-101
Identifier Type: -
Identifier Source: org_study_id