- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03746431
A Phase 1/2 Study of [225Ac]-FPI-1434 Injection
A Phase 1/2 Study of [225Ac]-FPI-1434 Injection in Patients With Locally Advanced or Metastatic Solid Tumours
Study Overview
Status
Conditions
Detailed Description
This study consists of a Phase 1 portion and a Phase 2 portion.
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: clinicaltrials@fusionpharma.com
- Phone Number: +1 (888) 506-4215
- Email: clinicaltrials@fusionpharma.com
Study Locations
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South Australia
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Adelaide, South Australia, Australia, 5000
- Completed
- Royal Adelaide Hospital
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Victoria
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Heidelberg, Victoria, Australia, 3084
- Recruiting
- Austin Hospital
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Active, not recruiting
- Juravinski Cancer Center - Hamilton Health
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Toronto, Ontario, Canada, M5G 2C1
- Completed
- Princess Margaret Cancer Centre
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Quebec
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Montréal, Quebec, Canada, H2X 0C1
- Recruiting
- Centre Hospitalier de I'Universite de Montreal
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Québec City, Quebec, Canada, G1R 2J6
- Active, not recruiting
- Quebec University Hospital- Laval
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California
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Duarte, California, United States, 91010
- Recruiting
- City of Hope
-
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Recruiting
- Dana-Farber Cancer Institute
-
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Recruiting
- Masonic Cancer Center, University of Minnesota
-
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New York
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Buffalo, New York, United States, 14203
- Completed
- Roswell Park Comprehensive Cancer Center
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New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Hospital of the University of Pennsylvania
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Texas
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Houston, Texas, United States, 77030
- Recruiting
- University of Texas MD Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
- 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-1R immunohistochemistry. 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 consent document.
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 systemic therapy, or for whom standard or curative systemic therapy does not exist or is not tolerable.
Imaging Eligibility
- 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:
- Systemic therapeutic radiopharmaceutical within 6 months prior to enrollment into this study.
- Contraindications to or inability to perform the required imaging procedures in this study (e.g., inability to lay flat during scan time)
- Uncontrolled brain metastasis, including but not limited to the need for treatment with steroids, surgery or radiation therapy.
- Anticancer therapy (including investigational agents) or external beam radiation therapy within 14 days of the dosing of [111In]-FPI-1547
- 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.
- Residual CTCAE ≥ Grade 2 side effects of prior therapy, with the exception of residual 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 or any component of the investigational drug formulation.
- 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.
- Received > 20 Gy prior radiation to large areas of the bone marrow
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: [225Ac]-FPI-1434 Single-Dose Escalation
|
[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 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.
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Experimental: [225Ac]-FPI-1434 Multi-Dose Escalation
[225Ac]-FPI-1434 treatment with or without pre-administration of FPI-1175 (cold antibody).
|
[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 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 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.
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Experimental: FPI-1175 Cold Antibody
|
[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 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 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.
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Experimental: [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 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 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 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose Escalation: Incidence of adverse events (AEs).
Time Frame: Approximately one year post final [225Ac]-FPI-1434 Injection.
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Phase 1
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Approximately one year post final [225Ac]-FPI-1434 Injection.
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Single-Dose Escalation: Incidence of dose limiting toxicities (DLTs).
Time Frame: 8 weeks.
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Phase 1
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8 weeks.
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Multi-Dose Escalation: Incidence of DLTs.
Time Frame: 6 weeks.
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Phase 1
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6 weeks.
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Dose Escalation: Incidence of clinically significant clinical laboratory abnormalities.
Time Frame: Approximately one year post final [225Ac]-FPI-1434 Injection.
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Phase 1
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Approximately one year post final [225Ac]-FPI-1434 Injection.
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Dose Escalation: Changes in electrocardiogram (ECG) parameters (PR, QRS, QT, and QTc intervals).
Time Frame: 4 weeks post final [225Ac]-FPI-1434 Injection.
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Phase 1
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4 weeks post final [225Ac]-FPI-1434 Injection.
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Cold Antibody Sub-Study: Changes in uptake of [111In]-FPI-1547 Injection following FPI-1175 Infusion in selected regions of interest on SPECT/CT images.
Time Frame: Within two weeks of the first [111In]-FPI-1547 Injection.
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Phase 1
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Within two weeks of the first [111In]-FPI-1547 Injection.
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Cold Antibody Sub-Study: Changes in radiation dose estimates for selected tissues, organs and whole body both for [111In]-FPI-1547 and [225Ac]-FPI-1434 Injection at various dose levels following FPI-1175 Infusion.
Time Frame: Within two weeks of the first [111In]-FPI-1547 Injection.
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Phase 1
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Within two weeks of the first [111In]-FPI-1547 Injection.
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Evaluate anti-tumour activity of [225Ac]-FPI-1434 regimen
Time Frame: Approximately one year post final [225Ac]-FPI-1434 injection.
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Phase 2
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Approximately one year post final [225Ac]-FPI-1434 injection.
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Objective response rate (ORR) RECIST v1.1.
Time Frame: Approximately one year post final [225Ac]-FPI-1434 Injection.
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Phase 2
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Approximately one year post final [225Ac]-FPI-1434 Injection.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose Escalation and Cold Antibody Sub-Study: Tumour uptake of [111In]-FPI-1547 in selected regions of interest on SPECT/CT images.
Time Frame: Dose Escalation: Within one week of the [111In]-FPI-1547 Injection. Cold-Antibody Sub-Study: Within two weeks of the first [111In]-FPI-1547 Injection.
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Phase 1 and 2
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Dose Escalation: Within one week of the [111In]-FPI-1547 Injection. Cold-Antibody Sub-Study: Within two weeks of the first [111In]-FPI-1547 Injection.
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Dose Escalation: Radiation doses for selected organs and whole body both for [111In]-FPI-1547 Injection and [225Ac]-FPI-1434 Injection.
Time Frame: Within one week of the [111In]-FPI-1547 Injection.
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Phase 1 and 2
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Within one week of the [111In]-FPI-1547 Injection.
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Dose Escalation and Cold-Antibody Sub-Study: Changes in radiation absorbed doses for tumour lesions for [225Ac]-FPI-1434.
Time Frame: Dose Escalation: Within one week of the [111In]-FPI-1547 Injection. Cold-Antibody Sub-Study: Within two weeks of the first [111In]-FPI-1547 Injection.
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Phase 1 and 2
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Dose Escalation: Within one week of the [111In]-FPI-1547 Injection. Cold-Antibody Sub-Study: Within two weeks of the first [111In]-FPI-1547 Injection.
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Dose Escalation and Cold-Antibody Sub-Study: Clearance for radioactivity and for the targeting antibody.
Time Frame: 4 weeks post final [225Ac]-FPI-1434 Injection.
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Phase 1 and 2
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4 weeks post final [225Ac]-FPI-1434 Injection.
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Dose Escalation and Cold-Antibody Sub-Study: Area under the curve (AUC) for radioactivity and for the targeting antibody.
Time Frame: 4 weeks post final [225Ac]-FPI-1434 Injection.
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Phase 1 and 2
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4 weeks post final [225Ac]-FPI-1434 Injection.
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Dose Escalation and Cold-Antibody Sub-Study: Cmax for radioactivity and for the targeting antibody.
Time Frame: 4 weeks post final [225Ac]-FPI-1434 Injection.
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Phase 1 and 2
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4 weeks post final [225Ac]-FPI-1434 Injection.
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Dose Escalation and Cold-Antibody Sub-Study: Half-life for radioactivity and for the targeting antibody.
Time Frame: 4 weeks post final [225Ac]-FPI-1434 Injection.
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Phase 1 and 2
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4 weeks post final [225Ac]-FPI-1434 Injection.
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Dose Escalation and Cold-Antibody Sub-Study: Objective response rate (ORR) (sum of complete and partial response) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Prostate Cancer Working Group 3 (PCWG3) guidelines.
Time Frame: Approximately one year post final [225Ac]-FPI-1434 Injection.
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Phase 1
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Approximately one year post final [225Ac]-FPI-1434 Injection.
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Dose Escalation: Changes in the corrected QT (QTc) interval in milliseconds after [225Ac]-FPI-1434 treatment, compared to baseline.
Time Frame: Approximately 24 hours from the time of [225Ac]-FPI-1434 Injection administration.
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Phase 1 and 2
|
Approximately 24 hours from the time of [225Ac]-FPI-1434 Injection administration.
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Dose Escalation and Cold-Antibody Sub-Study: Changes in human growth hormone (hGh) following [111In]-FPI-1547 Injection and [225Ac]-FPI-1434 Injection.
Time Frame: 4 weeks post final [225Ac]-FPI-1434 Injection.
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Phase 1 and 2
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4 weeks post final [225Ac]-FPI-1434 Injection.
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Dose Escalation and Cold-Antibody Sub-Study: Changes in insulin-like growth factor 1 (IGF-1) following [111In]-FPI-1547 Injection and [225Ac]-FPI-1434 Injection.
Time Frame: 4 weeks post final [225Ac]-FPI-1434 Injection.
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Phase 1 and 2
|
4 weeks post final [225Ac]-FPI-1434 Injection.
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Dose Escalation and Cold-Antibody Sub-Study: Changes in insulin-like growth factor binding protein 3 (IGFBP-3) following [111In]-FPI-1547 Injection and [225Ac]-FPI-1434 Injection.
Time Frame: 4 weeks post final [225Ac]-FPI-1434 Injection.
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Phase 1 and 2
|
4 weeks post final [225Ac]-FPI-1434 Injection.
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Cold Antibody Sub-Study: Incidence of AEs.
Time Frame: Approximately one year post final [225Ac]-FPI-1434 Injection.
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Phase 1 and 2
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Approximately one year post final [225Ac]-FPI-1434 Injection.
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Cold Antibody Sub-Study: Incidence of clinically significant clinical laboratory abnormalities.
Time Frame: Approximately one year post final [225Ac]-FPI-1434 Injection.
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Phase 1 and 2
|
Approximately one year post final [225Ac]-FPI-1434 Injection.
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Cold Antibody Sub-Study: Changes in ECG parameters (PR, QRS, QT, and QTc intervals).
Time Frame: 4 weeks post final [225Ac]-FPI-1434 Injection.
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Phase 1 and 2
|
4 weeks post final [225Ac]-FPI-1434 Injection.
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Dose Escalation and Cold-Antibody Sub-Study: Time to response (TTR).
Time Frame: Approximately one year post final [225Ac]-FPI-1434 Injection.
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Phase 1 and 2
|
Approximately one year post final [225Ac]-FPI-1434 Injection.
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Dose Escalation and Cold-Antibody Sub-Study: Duration of response (DoR).
Time Frame: Approximately one year post final [225Ac]-FPI-1434 Injection.
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Phase 1 and 2
|
Approximately one year post final [225Ac]-FPI-1434 Injection.
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Dose Escalation and Cold-Antibody Sub-Study: Progression free survival (PFS).
Time Frame: Approximately one year post final [225Ac]-FPI-1434 Injection.
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Phase 1 and 2
|
Approximately one year post final [225Ac]-FPI-1434 Injection.
|
Dose Escalation and Cold-Antibody Sub-Study: Time to Progression (TTP).
Time Frame: Approximately one year post final [225Ac]-FPI-1434 Injection.
|
Phase 1 and 2
|
Approximately one year post final [225Ac]-FPI-1434 Injection.
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Dose Escalation and Cold-Antibody Sub-Study: Disease control rate (DCR).
Time Frame: Approximately one year post final [225Ac]-FPI-1434 Injection.
|
Phase 1 and 2
|
Approximately one year post final [225Ac]-FPI-1434 Injection.
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Dose Escalation and Cold-Antibody Sub-Study: Overall survival (OS).
Time Frame: Approximately one year post final [225Ac]-FPI-1434 Injection.
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Phase 1 and 2
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Approximately one year post final [225Ac]-FPI-1434 Injection.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Julia Kazakin, MD, Fusion Pharmaceuticals Inc.
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Diseases
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Breast Diseases
- Head and Neck Neoplasms
- Carcinoma, Squamous Cell
- Adrenal Gland Diseases
- Adrenal Cortex Neoplasms
- Adrenal Gland Neoplasms
- Adrenal Cortex Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Breast Neoplasms
- Carcinoma
- Endometrial Neoplasms
- Squamous Cell Carcinoma of Head and Neck
- Triple Negative Breast Neoplasms
- Adrenocortical Carcinoma
Other Study ID Numbers
- FPX-01-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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