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TerminatedPhase 1 / Phase 2NCT05363605
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studied[225Ac]-FPI-1966 and [111In]-FPI-1967

Plus 1 other study approaches.

Who it may be forAdvanced Solid Tumor · Head and Neck Squamous Cell Carcinoma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 19, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?6 U.S. locations

Locations may change over time.

Who runs it?Fusion Pharmaceuticals Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Fusion Pharmaceuticals Inc.
Interventions being studied
Drug: [225Ac]-FPI-1966; Drug: [111In]-FPI-1967; Biological: vofatamab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Key
  • 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • City of HopeDuarte, California
  • University of California, San FranciscoSan Francisco, California
  • University of Iowa Hospitals and ClinicsIowa City, Iowa
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • GC MurdochMurdoch, Western Australia
  • St Vincent's HospitalMelbourne

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 19, 2023. Always confirm current availability with the study team.

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