A Study of [225Ac]-FPI-1966 in Participants With Advanced Solid Tumours

• Status: Recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fusion Pharmaceuticals Inc.

Criteria

Key Inclusion Criteria:

• 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

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 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