TERMINATED

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

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 225-Ac Labelled Humanized Monoclonal Antibody Against IGF-1R [225Ac]-FPI-1434 IGF-IR Targeted Alpha Therapeutic IGF-IR Radioligand Therapy Radiopharmaceuticals

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase 1 Study of [225Ac]-FPI-1434 Injection in Patients With Locally Advanced or Metastatic Solid Tumours

Quick Facts

Study Start:2019-01-17

Study Completion:2025-12-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT03746431

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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. 11. Prior to the initial \[225Ac\]-FPI-1434 cycle: Sufficient target expression in at least 1 lesion following \[111In\]-FPI-1547 and SPECT imaging.	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

Inclusion Criteria

Exclusion 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.
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.
11. Prior to the initial \[225Ac\]-FPI-1434 cycle: Sufficient target expression in at least 1 lesion following \[111In\]-FPI-1547 and SPECT imaging.

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

Contacts and Locations

Principal Investigator

Julia Kazakin, MD

STUDY_DIRECTOR

Fusion Pharmaceuticals Inc.

Study Locations (Sites)

City of Hope

Duarte, California, 91010

United States

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455

United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14203

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Fusion Pharmaceuticals Inc.

Julia Kazakin, MD, STUDY_DIRECTOR, Fusion Pharmaceuticals Inc.

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

Study Start Date2019-01-17

Study Completion Date2025-12-03

Study Record Updates

Study Start Date2019-01-17

Study Completion Date2025-12-03

Terms related to this study

Keywords Provided by Researchers

225-Ac Labelled Humanized Monoclonal Antibody Against IGF-1R
[225Ac]-FPI-1434
IGF-IR Targeted Alpha Therapeutic
IGF-IR Radioligand Therapy
Radiopharmaceuticals

Additional Relevant MeSH Terms

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