Study Results
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Basic Information
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TERMINATED
PHASE1
78 participants
INTERVENTIONAL
2019-01-17
2025-12-03
Brief Summary
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Detailed Description
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Phase 1 includes the following cohorts: Single dose-ascending cohorts and Multi- dose ascending cohorts of \[225Ac\]-FPI-1434 and Multi- dose ascending cohorts evaluating administration of FPI-1175 (cold antibody), followed by, \[225Ac\]-FPI-1434 (cold + hot), with cycles repeating every 42 days. And Cold Antibody Sub-study evaluating administration of ascending doses of FPI-1175 followed by \[111In\]-FPI-1547.
The Phase 2 will evaluate \[111In\]-FPI-1547 and \[225Ac\]-FPI-1434 with or without FPI-1175 in tumour-specific cohorts. The decision to utilize FPI-1175 in the Phase 2 portion of the study will be determined based on Phase 1 data, including safety, tolerability, pharmacokinetic and dosimetry results.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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[225Ac]-FPI-1434 Single-Dose Escalation
[111In]-FPI-1547 Injection
\[111In\]-FPI-1547 is a targeted radioimmuno-imaging agent that consists of FPI-1175, an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody, a bifunctional chelate, and Indium-111, a radionuclide. Patients will receive \[111In\]-FPI-1547 Injection of 185 MBq (5 mCi) for imaging.
[225Ac]-FPI-1434 Injection single-dose
\[225Ac\]-FPI-1434 is a targeted alpha radioimmuno-therapeutic agent that consists of FPI-1175, an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody, a bifunctional chelate, and Actinium-225, an alpha-emitting radionuclide. Patients will receive a single dose of \[225\]-FPI-1434 Injection. Dose is per cohort assignment.
[225Ac]-FPI-1434 Multi-Dose Escalation
\[225Ac\]-FPI-1434 treatment with or without pre-administration of FPI-1175 (cold antibody).
[111In]-FPI-1547 Injection
\[111In\]-FPI-1547 is a targeted radioimmuno-imaging agent that consists of FPI-1175, an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody, a bifunctional chelate, and Indium-111, a radionuclide. Patients will receive \[111In\]-FPI-1547 Injection of 185 MBq (5 mCi) for imaging.
[225Ac]-FPI-1434 Injection multi-dose
\[225Ac\]-FPI-1434 is a targeted alpha radioimmuno-therapeutic agent that consists of FPI-1175, an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody, a bifunctional chelate, and Actinium-225, an alpha-emitting radionuclide. Patients will receive multiple doses of \[225Ac\]-FPI-1434 Injection. Dose is per cohort assignment.
FPI-1175 Infusion
FPI-1175 is an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody without a radioisotope. Patients will receive FPI-1175 Infusion at a dose per cohort assignment.
FPI-1175 Cold Antibody
[111In]-FPI-1547 Injection
\[111In\]-FPI-1547 is a targeted radioimmuno-imaging agent that consists of FPI-1175, an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody, a bifunctional chelate, and Indium-111, a radionuclide. Patients will receive \[111In\]-FPI-1547 Injection of 185 MBq (5 mCi) for imaging.
[225Ac]-FPI-1434 Injection multi-dose
\[225Ac\]-FPI-1434 is a targeted alpha radioimmuno-therapeutic agent that consists of FPI-1175, an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody, a bifunctional chelate, and Actinium-225, an alpha-emitting radionuclide. Patients will receive multiple doses of \[225Ac\]-FPI-1434 Injection. Dose is per cohort assignment.
FPI-1175 Infusion
FPI-1175 is an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody without a radioisotope. Patients will receive FPI-1175 Infusion at a dose per cohort assignment.
[225Ac]-FPI-1434 Multi-Dose
Phase 2 Tumour Cohort - Head \& Neck Squamous Cell Carcinoma (HNSCC), Endometrial Cancer, Cervical Cancer, Ovarian Cancer, Triple Negative Breast Cancer (TNBC), HER2-negative, Adrenocortical Carcinoma (ACC), Uveal Melanoma, \[225Ac\]-FPI-1434 treatment with or without pre-administration of FPI-1175 (cold antibody).
[111In]-FPI-1547 Injection
\[111In\]-FPI-1547 is a targeted radioimmuno-imaging agent that consists of FPI-1175, an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody, a bifunctional chelate, and Indium-111, a radionuclide. Patients will receive \[111In\]-FPI-1547 Injection of 185 MBq (5 mCi) for imaging.
[225Ac]-FPI-1434 Injection multi-dose
\[225Ac\]-FPI-1434 is a targeted alpha radioimmuno-therapeutic agent that consists of FPI-1175, an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody, a bifunctional chelate, and Actinium-225, an alpha-emitting radionuclide. Patients will receive multiple doses of \[225Ac\]-FPI-1434 Injection. Dose is per cohort assignment.
FPI-1175 Infusion
FPI-1175 is an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody without a radioisotope. Patients will receive FPI-1175 Infusion at a dose per cohort assignment.
Interventions
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[111In]-FPI-1547 Injection
\[111In\]-FPI-1547 is a targeted radioimmuno-imaging agent that consists of FPI-1175, an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody, a bifunctional chelate, and Indium-111, a radionuclide. Patients will receive \[111In\]-FPI-1547 Injection of 185 MBq (5 mCi) for imaging.
[225Ac]-FPI-1434 Injection multi-dose
\[225Ac\]-FPI-1434 is a targeted alpha radioimmuno-therapeutic agent that consists of FPI-1175, an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody, a bifunctional chelate, and Actinium-225, an alpha-emitting radionuclide. Patients will receive multiple doses of \[225Ac\]-FPI-1434 Injection. Dose is per cohort assignment.
FPI-1175 Infusion
FPI-1175 is an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody without a radioisotope. Patients will receive FPI-1175 Infusion at a dose per cohort assignment.
[225Ac]-FPI-1434 Injection single-dose
\[225Ac\]-FPI-1434 is a targeted alpha radioimmuno-therapeutic agent that consists of FPI-1175, an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody, a bifunctional chelate, and Actinium-225, an alpha-emitting radionuclide. Patients will receive a single dose of \[225\]-FPI-1434 Injection. Dose is per cohort assignment.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Fusion Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Julia Kazakin, MD
Role: STUDY_DIRECTOR
Fusion Pharmaceuticals Inc.
Locations
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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
Countries
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References
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Anderson PM, Subbiah V, Trucco MM. Current and future targeted alpha particle therapies for osteosarcoma: Radium-223, actinium-225, and thorium-227. Front Med (Lausanne). 2022 Nov 15;9:1030094. doi: 10.3389/fmed.2022.1030094. eCollection 2022.
Martiniova L, Zielinski RJ, Lin M, DePalatis L, Ravizzini GC. The Role of Radiolabeled Monoclonal Antibodies in Cancer Imaging and ADC Treatment. Cancer J. 2022 Nov-Dec 01;28(6):446-453. doi: 10.1097/PPO.0000000000000625.
Other Identifiers
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FPX-01-01
Identifier Type: -
Identifier Source: org_study_id
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