A Phase 1 Study of [225Ac]-FPI-1434 Injection

Stopped early · Phase 1

Conditions studied: Advanced Solid Tumours, Endometrial Cancer, Cervical Cancer, Ovarian Cancer, Breast Cancer, Triple Negative Breast Cancer (TNBC), HER2-negative Breast Cancer, Head and Neck Squamous Cell Carcinoma (HNSCC), Adrenocortical Carcinoma, Uveal Melanoma

In brief

This is a first-in-human Phase 1/2, non-randomized, multi-centre, open-label clinical study designed to investigate safety, tolerability, PK, and preliminary anti-tumour activity of \[225Ac\]-FPI-1434 (radioimmuno-therapeutic agent) in patients with solid tumours that demonstrate uptake of \[111In\]-FPI-1547 (radioimmuno-imaging agent), and to establish the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of repeat doses of \[225Ac\]-FPI-1434 Injection in patients with solid tumours that demonstrate uptake of \[111In\]-FPI-1547 (radioimmuno-imaging agent).

Key facts

Study ID

NCT03746431

Run by

Fusion Pharmaceuticals Inc.

People needed

78

Starts

2019-01-17

Expected to finish

2025-12-03

Last updated by the study team

2026-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically documented, definitively diagnosed, advanced solid tumour that is refractory to all standard treatment, for which no standard treatment is available, or it is contraindicated, or the patient refuses standard therapy.
• Measurable or evaluable disease in accordance with RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
• Life expectancy of greater than 3 months as judged by the treating physician.
• Available tumour tissue (either archival or fresh biopsy) for IGF-1R immunohistochemistry. Submission of the tissue is not required prior to enrollment.
• Adequate heart, kidney, and liver function
• Adequate bone marrow reserves
• Ability to understand and the willingness to sign a written informed consent document.
• Phase 2 Specific
• Histologically and/or cytologically documented diagnosis of locally advanced, inoperable, metastatic, or recurrent solid tumour types: endometrial, cervical, ovarian, TNBC, HER 2-negative breast, HNSCC, ACC, or uveal melanoma.
• Have measurable disease per RECIST 1.1 Failure to respond to standard systemic therapy, or for whom standard or curative systemic therapy does not exist or is not tolerable.
• Imaging Eligibility
• Prior to the initial [225Ac]-FPI-1434 cycle: Sufficient target expression in at least 1 lesion following [111In]-FPI-1547 and SPECT imaging.

You may not qualify if…

• Systemic therapeutic radiopharmaceutical within 6 months prior to enrollment into this study.
• Contraindications to or inability to perform the required imaging procedures in this study (e.g., inability to lay flat during scan time)
• Uncontrolled brain metastasis, including but not limited to the need for treatment with steroids, surgery or radiation therapy.
• Anticancer therapy (including investigational agents) or external beam radiation therapy within 14 days of the dosing of [111In]-FPI-1547
• Has known additional malignancy that is progressing or has required active treatment within the past 3 years. Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (e.g., breast cancer, cervical cancer, prostate) that have undergone potentially curative therapy are not excluded.
• Residual CTCAE ≥ Grade 2 side effects of prior therapy, with the exception of residual grade 2 alopecia.
• Prior organ transplantation, including stem cell transplantation.
• Any prior treatment with nitrosoureas or actinomycin-D.
• Clinically relevant levels of protein in the urine
• Known or suspected allergies or contraindications to the Investigational Products or any component of the investigational drug formulation.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes, or psychiatric illness/social situations that would limit compliance with study requirements.
• Received > 20 Gy prior radiation to large areas of the bone marrow

Where it is running

• City of Hope — Duarte, California, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota, United States
• Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Austin Hospital — Heidelberg, Victoria, Australia
• Juravinski Cancer Center - Hamilton Health — Hamilton, Ontario, Canada
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada
• Centre Hospitalier De I'Universite de Montreal — Montreal, Quebec, Canada
• Quebec University Hospital- Laval — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

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