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

F

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)

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

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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