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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

INTRODUCTION

  • Org Study ID: FPI-1966-101
  • Secondary ID: N/A
  • NTC ID: NCT05363605
  • Sponsor: Fusion Pharmaceuticals Inc.
Sponsor website

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.

  • Overall Status
    Recruiting
  • Start Date
    April 20, 2022
  • Phase
    Phase 1, Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Phase 1: Phase 1: Incidence of AEs to evaluate safety and tolerability of [225Ac]-FPI-1966, [111In]-FPI-1967, and vofatamab.

Primary Outcome 1 - Timeframe: Approximately 2 years post final administration

Primary Outcome 2 - Measure: Phase 1: Maximum tolerated dose (MTD) of [225Ac]-FPI-1966

Primary Outcome 2 - Timeframe: Approximately 42 days post administration.

Primary Outcome 3 - Measure: Phase 1: Radiation dose of [111In]-FPI-1967 and [225Ac]-FPI-1966 (whole body, organs, and selected regions of interest)

Primary Outcome 3 - Timeframe: Within one week of administration

Primary Outcome 4 - Measure: Phase 1: Effect of pre-dose administration of vofatamab on the radiation dosimetry of [111In]-FPI-1967 and [225Ac]-FPI-1966.

Primary Outcome 4 - Timeframe: Within one week of administration

Primary Outcome 5 - Measure: Phase 2: Objective response rate (ORR) (sum of complete and partial response) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Primary Outcome 5 - Timeframe: Up to two years post final administration.

CONDITION

  • 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

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Julia Kazakin, MD

Role: Study Director

Affiliation: Fusion Pharmaceuticals Inc.

Overall Contact

Name: Julia Kazakin, MD

Phone: +1 (888) 506-4215

Email: clinicaltrials@fusionpharma.com

LOCATION

Facility Status Contact