Investigating a new treatment for advanced solid tumors using a targeted radiopharmaceutical
A Phase 1/2 Study of [225Ac]-FPI-1434 Injection in Patients With Locally Advanced or Metastatic Solid Tumours
This study is testing a new targeted treatment for people with advanced solid tumors to see if it is safe and how well it works.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 253 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fusion Pharmaceuticals Inc. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 13 sites (Duarte, California and 12 other locations) |
| Trial ID | NCT03746431 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a Phase 1/2 study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of [225Ac]-FPI-1434, a radioimmuno-therapeutic agent, in patients with advanced solid tumors. The study includes both single and multi-dose ascending cohorts, with the aim of establishing the maximum tolerated dose and recommended Phase 2 dose. The Phase 2 portion will assess the efficacy of [225Ac]-FPI-1434 in combination with other agents in specific tumor types based on Phase 1 findings.
Who should consider this trial
Good fit: Ideal candidates include patients with pathologically documented advanced solid tumors that are refractory to all standard treatments and have measurable or evaluable disease.
Not a fit: Patients with tumors that are not advanced, operable, or for which standard treatment is still effective may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are resistant to standard therapies.
How similar studies have performed: While this approach is novel, similar targeted radiopharmaceutical therapies have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. 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.
2. Measurable or evaluable disease in accordance with RECIST 1.1.
3. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
4. Life expectancy of greater than 3 months as judged by the treating physician.
5. Available tumour tissue (either archival or fresh biopsy) for IGF-1R immunohistochemistry. Submission of the tissue is not required prior to enrollment.
6. Adequate heart, kidney, and liver function
7. Adequate bone marrow reserves
8. Ability to understand and the willingness to sign a written informed consent document.
Phase 2 Specific
9. 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.
10. 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
11. Prior to the initial \[225Ac\]-FPI-1434 cycle: Sufficient target expression in at least 1 lesion following \[111In\]-FPI-1547 and SPECT imaging.
Exclusion Criteria:
1. Systemic therapeutic radiopharmaceutical within 6 months prior to enrollment into this study.
2. Contraindications to or inability to perform the required imaging procedures in this study (e.g., inability to lay flat during scan time)
3. Uncontrolled brain metastasis, including but not limited to the need for treatment with steroids, surgery or radiation therapy.
4. Anticancer therapy (including investigational agents) or external beam radiation therapy within 14 days of the dosing of \[111In\]-FPI-1547
5. 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.
6. Residual CTCAE ≥ Grade 2 side effects of prior therapy, with the exception of residual grade 2 alopecia.
7. Prior organ transplantation, including stem cell transplantation.
8. Any prior treatment with nitrosoureas or actinomycin-D.
9. Clinically relevant levels of protein in the urine
10. Known or suspected allergies or contraindications to the Investigational Products or any component of the investigational drug formulation.
11. 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.
12. Received \> 20 Gy prior radiation to large areas of the bone marrow
Where this trial is running
Duarte, California and 12 other locations
- City of Hope — Duarte, California, United States (Completed)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (Completed)
- Memorial Sloan Kettering Cancer Center — New York City, New York, United States (Completed)
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Completed)
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Completed)
- Royal Adelaide Hospital — Adelaide, South Australia, Australia (Completed)
- Austin Hospital — Heidelberg, Victoria, Australia (Recruiting)
- Juravinski Cancer Center - Hamilton Health — Hamilton, Ontario, Canada (Completed)
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Completed)
- Centre Hospitalier De I'Universite de Montreal — Montréal, Quebec, Canada (Recruiting)
- Quebec University Hospital- Laval — Québec City, Quebec, Canada (Completed)
Study contacts
- Study coordinator: clinicaltrials@fusionpharma.com
- Email: clinicaltrials@fusionpharma.com
- Phone: +1 (888) 506-4215
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.