Spots Global Cancer Trial Database for A Study of [225Ac]-FPI-1966 in Participants With Advanced Solid Tumours

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Trial Identification

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

Official Title: A Phase 1/2 Study of [225Ac]-FPI-1966, [111In]-FPI-1967, and Vofatamab in Participants With FGFR3-expressing Advanced, Inoperable, Metastatic and/or Recurrent Solid Tumours

Study ID: NCT05363605

Conditions

Advanced Solid Tumor

Head and Neck Squamous Cell Carcinoma

Bladder Carcinoma

Susceptible FGFR3 Genetic Alterations

FGFR3

FGFR3 Overexpression

FGFR3 Receptor

FGFR3 Protein Overexpression

Interventions

[225Ac]-FPI-1966

[111In]-FPI-1967

vofatamab

Study Description

Brief Summary: 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.

Detailed 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.