A Phase 1/2 Study of [225Ac]-FPI-1434 Injection
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).
Conditions:
🦠 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
πŸ—“οΈ Study Start (Actual) 17 January 2019
πŸ—“οΈ Primary Completion (Estimated) June 2024
βœ… Study Completion (Estimated) June 2026
πŸ‘₯ Enrollment (Estimated) 253
πŸ”¬ Study Type INTERVENTIONAL
πŸ“Š Phase PHASE1
Locations:
πŸ“ Duarte, California, United States
πŸ“ Boston, Massachusetts, United States
πŸ“ Minneapolis, Minnesota, United States
πŸ“ Buffalo, New York, United States
πŸ“ New York, New York, United States
πŸ“ Philadelphia, Pennsylvania, United States
πŸ“ Houston, Texas, United States
πŸ“ Adelaide, South Australia, Australia
πŸ“ Heidelberg, Victoria, Australia
πŸ“ Hamilton, Ontario, Canada
πŸ“ Toronto, Ontario, Canada
πŸ“ MontrΓ©al, Quebec, Canada
πŸ“ QuΓ©bec City, Quebec, Canada

πŸ“‹ Eligibility Criteria

Description

    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 β‰₯ 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

πŸ—“οΈ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 9 November 2018
  • First Submitted that Met QC Criteria 15 November 2018
  • First Posted 19 November 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 20 June 2024
  • Last Update Posted 24 June 2024
  • Last Verified June 2024