Overview

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