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

Fusion Pharmaceuticals

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Breast Cancer; FGFR3 Receptor; Bladder Carcinoma; Advanced Solid Tumor; FGFR3 Protein Overexpression; Lung Cancer; Susceptible FGFR3 Genetic Alterations; Ovarian Cancer; Liver Cancer; FGFR3; Gastric Cancer; FGFR3 Overexpression; Colorectal Cancer; Head and Neck Squamous Cell Carcinoma

Treatments: Drug: [111In]-FPI-1967; Biological: vofatamab; Drug: [225Ac]-FPI-1966

Study type: Interventional

Funder types: Industry

Identifiers

NCT05363605

FPI-1966-101

Details and patient eligibility

About

This first-in-human study evaluates safety, tolerability and distribution of [225Ac] FPI-1966, [111In]-FPI-1967, and vofatamab in patients with FGFR3-expressing solid tumors.

Full description

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Phase 1

Experimental group

Description:

Depending on assigned cohort, [In111]-FPI-1967/[225Ac]-FPI-1966 will be administered with or without pre-dosing with vofatamab.

Treatment:

Drug: [225Ac]-FPI-1966

Biological: vofatamab

Drug: [111In]-FPI-1967

Phase 2

Experimental group

Description:

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.

Treatment:

Drug: [225Ac]-FPI-1966

Biological: vofatamab

Drug: [111In]-FPI-1967