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Cancer

FUSION FPI-1966-101

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.

Trial overview

Topic

Advanced, Inoperable, Metastatic and/or Recurrent Solid Tumours

Description

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 Phase 1, Cohort 1 of the study. [225Ac]-FPI-1966 will be evaluated in Phase 1 across 5 planned, ascending dose cohorts using a 3 + 3 dose escalation design. Participants will receive 185 MBq of [111In]-FPI-1967 during the imaging screening period to determine biodistribution and estimate radiation exposure to critical organs.

Once the recommended phase 2 dose (RP2D) regimen is established and confirmed, three expansion cohorts may be initiated in parallel.

Eligibility criteria

Inclusion

  • Signed ICF prior to initiation of any study-specific procedures
  • Male and female participants, ≥ 18 years of age, with 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 with at least one non-nodal lesion of ≥ 20 mm in the longest diameter
  • Available tumour tissue (either archival within the last two years or fresh biopsy) for FGFR3 immunohistochemistry and biomarker analysis (submission of tissue not required prior to enrolment)
  • Adequate bone marrow, cardiovascular, hepatic, and renal function

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 five half-lives or four weeks, whichever is shorter, prior to administration of the first dose of [111In]-FPI-1967
  • Concurrent serious co-morbidities that could limit participants' full participation and compliance

 

Please contact a member of the study team for the full inclusion and exclusion criteria.

Further information

Please click here for more information

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