Phase
Condition
Carcinoma
Ovarian Cancer
Endometrial Cancer
Treatment
[225Ac]-FPI-1434 Injection single-dose
FPI-1175 Infusion
[111In]-FPI-1547 Injection
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Pathologically documented, definitively diagnosed, advanced solid tumour that isrefractory 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-1Rimmunohistochemistry. 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 consentdocument. 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 systemictherapy, or for whom standard or curative systemic therapy does not exist or is nottolerable. Imaging Eligibility
Prior to the initial [225Ac]-FPI-1434 cycle: Sufficient target expression in atleast 1 lesion following [111In]-FPI-1547 and SPECT imaging.
Exclusion
Exclusion Criteria:
Systemic therapeutic radiopharmaceutical within 6 months prior to enrollment intothis study.
Contraindications to or inability to perform the required imaging procedures in thisstudy (e.g., inability to lay flat during scan time)
Uncontrolled brain metastasis, including but not limited to the need for treatmentwith steroids, surgery or radiation therapy.
Anticancer therapy (including investigational agents) or external beam radiationtherapy within 14 days of the dosing of [111In]-FPI-1547
Has known additional malignancy that is progressing or has required active treatmentwithin the past 3 years. Patients with basal cell carcinoma of the skin, squamouscell carcinoma of the skin or carcinoma in situ (e.g., breast cancer, cervicalcancer, prostate) that have undergone potentially curative therapy are not excluded.
Residual CTCAE ≥ Grade 2 side effects of prior therapy, with the exception ofresidual 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 orany component of the investigational drug formulation.
Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, diabetes, or psychiatric illness/social situations that would limitcompliance with study requirements.
Received > 20 Gy prior radiation to large areas of the bone marrow
Study Design
Study Description
Connect with a study center
Royal Adelaide Hospital
Adelaide, South Australia 5000
AustraliaCompleted
Austin Hospital
Heidelberg, Victoria 3084
AustraliaActive - Recruiting
Juravinski Cancer Center - Hamilton Health
Hamilton, Ontario L8V 5C2
CanadaCompleted
Princess Margaret Cancer Centre
Toronto, Ontario M5G 2C1
CanadaCompleted
Centre Hospitalier De I'Universite de Montreal
Montréal, Quebec H2X 0C1
CanadaActive - Recruiting
Quebec University Hospital- Laval
Québec City, Quebec G1R 2J6
CanadaCompleted
Juravinski Cancer Center - Hamilton Health
Hamilton, Ontario, L8V 5C2
CanadaSite Not Available
Centre Hospitalier De I'Universite de Montreal
Montréal, Quebec, H2X 0C1
CanadaSite Not Available
City of Hope
Duarte, California 91010
United StatesCompleted
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesActive - Recruiting
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota 55455
United StatesActive - Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York 14203
United StatesCompleted
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York City, New York 10065
United StatesCompleted
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesCompleted
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesCompleted
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