Breast Cancer Clinical Trial
A Study of [225Ac]-FPI-1966 in Participants With Advanced Solid Tumours
This is a first-in-human, Phase 1/2, non-randomized, multi-centre, open-label clinical study designed to investigate safety, tolerability, dosimetry, biodistribution, and PK of [225Ac] FPI-1966, [111In]-FPI-1967, and vofatamab and the preliminary anti-tumour activity of [225Ac]-FPI-1966 in participants with FGFR3-expressing advanced, inoperable, metastatic, and/or recurrent solid tumours. Phase 1 consists of five multiple dose escalation cohorts. Phase 2 consists of two tumour-specific cohorts and one basket cohort.
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 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.
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
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There are 5 Locations for this study
Duarte California, 91010, United States
San Francisco California, 94143, United States
Iowa City Iowa, 52242, United States
New York New York, 10065, United States
Murdoch Western Australia, 6150, Australia
Melbourne , , Australia
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