This study is in progress, not accepting new patients

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

a study on Solid Tumor Head and Neck Squamous Cell Carcinoma Squamous Cell Carcinoma Bladder Cancer Susceptible FGFR3 Genetic Alterations FGFR3 FGFR3 Overexpression FGFR3 Receptor FGFR3 Protein Overexpression Ovarian Cancer Colorectal Cancer Breast Cancer Liver Cancer Lung Cancer Stomach Cancer Carcinoma Head and Neck Cancer Urinary Bladder Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

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

Details

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.

Keywords

Advanced Solid Tumor, Head and Neck Squamous Cell Carcinoma, Bladder Carcinoma, Susceptible FGFR3 Genetic Alterations, FGFR3, FGFR3 Overexpression, FGFR3 Receptor, FGFR3 Protein Overexpression, Ovarian Cancer, Colorectal Cancer, Breast Cancer, Liver Cancer, Lung Cancer, Gastric Cancer, Actinium-225, Targeted Alpha Therapy, Radiopharmaceutical, Radioimmunoconjugate, Theranostic, Theragnostic, Radioligand, Antineoplastic agents, [225Ac]-FPI-1966, Carcinoma, Squamous Cell Carcinoma of Head and Neck, Urinary Bladder Neoplasms, [111In]-FPI-1967, vofatamab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UCSF
    San Francisco California 94143 United States
  • City of Hope
    Duarte California 91010 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Fusion Pharmaceuticals Inc.
Links
Sponsor website
ID
NCT05363605
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
About 6 people participating
Last Updated