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A Phase 1/2 Study of [225Ac]-FPI-1434 Injection

Primary Purpose

Advanced Solid Tumours, Endometrial Cancer, Cervical Cancer

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
[111In]-FPI-1547 Injection
[225Ac]-FPI-1434 Injection multi-dose
FPI-1175 Infusion
[225Ac]-FPI-1434 Injection single-dose
Sponsored by
Fusion Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumours focused on measuring 225-Ac Labelled Humanized Monoclonal Antibody Against IGF-1R, [225Ac]-FPI-1434, IGF-IR Targeted Alpha Therapeutic, IGF-IR Radioligand Therapy, Radiopharmaceuticals

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 ≥ 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

Sites / Locations

  • City of HopeRecruiting
  • Dana-Farber Cancer InstituteRecruiting
  • Masonic Cancer Center, University of MinnesotaRecruiting
  • Roswell Park Comprehensive Cancer Center
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Hospital of the University of PennsylvaniaRecruiting
  • University of Texas MD Anderson Cancer CenterRecruiting
  • Royal Adelaide Hospital
  • Austin HospitalRecruiting
  • Juravinski Cancer Center - Hamilton Health
  • Princess Margaret Cancer Centre
  • Centre Hospitalier De I'Universite de MontrealRecruiting
  • Quebec University Hospital- Laval

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

[225Ac]-FPI-1434 Single-Dose Escalation

[225Ac]-FPI-1434 Multi-Dose Escalation

FPI-1175 Cold Antibody

[225Ac]-FPI-1434 Multi-Dose

Arm Description

[225Ac]-FPI-1434 treatment with or without pre-administration of FPI-1175 (cold antibody).

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).

Outcomes

Primary Outcome Measures

Dose Escalation: Incidence of adverse events (AEs).
Phase 1
Single-Dose Escalation: Incidence of dose limiting toxicities (DLTs).
Phase 1
Multi-Dose Escalation: Incidence of DLTs.
Phase 1
Dose Escalation: Incidence of clinically significant clinical laboratory abnormalities.
Phase 1
Dose Escalation: Changes in electrocardiogram (ECG) parameters (PR, QRS, QT, and QTc intervals).
Phase 1
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.
Phase 1
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.
Phase 1
Evaluate anti-tumour activity of [225Ac]-FPI-1434 regimen
Phase 2
Objective response rate (ORR) RECIST v1.1.
Phase 2

Secondary Outcome Measures

Dose Escalation and Cold Antibody Sub-Study: Tumour uptake of [111In]-FPI-1547 in selected regions of interest on SPECT/CT images.
Phase 1 and 2
Dose Escalation: Radiation doses for selected organs and whole body both for [111In]-FPI-1547 Injection and [225Ac]-FPI-1434 Injection.
Phase 1 and 2
Dose Escalation and Cold-Antibody Sub-Study: Changes in radiation absorbed doses for tumour lesions for [225Ac]-FPI-1434.
Phase 1 and 2
Dose Escalation and Cold-Antibody Sub-Study: Clearance for radioactivity and for the targeting antibody.
Phase 1 and 2
Dose Escalation and Cold-Antibody Sub-Study: Area under the curve (AUC) for radioactivity and for the targeting antibody.
Phase 1 and 2
Dose Escalation and Cold-Antibody Sub-Study: Cmax for radioactivity and for the targeting antibody.
Phase 1 and 2
Dose Escalation and Cold-Antibody Sub-Study: Half-life for radioactivity and for the targeting antibody.
Phase 1 and 2
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.
Phase 1
Dose Escalation: Changes in the corrected QT (QTc) interval in milliseconds after [225Ac]-FPI-1434 treatment, compared to baseline.
Phase 1 and 2
Dose Escalation and Cold-Antibody Sub-Study: Changes in human growth hormone (hGh) following [111In]-FPI-1547 Injection and [225Ac]-FPI-1434 Injection.
Phase 1 and 2
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.
Phase 1 and 2
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.
Phase 1 and 2
Cold Antibody Sub-Study: Incidence of AEs.
Phase 1 and 2
Cold Antibody Sub-Study: Incidence of clinically significant clinical laboratory abnormalities.
Phase 1 and 2
Cold Antibody Sub-Study: Changes in ECG parameters (PR, QRS, QT, and QTc intervals).
Phase 1 and 2
Dose Escalation and Cold-Antibody Sub-Study: Time to response (TTR).
Phase 1 and 2
Dose Escalation and Cold-Antibody Sub-Study: Duration of response (DoR).
Phase 1 and 2
Dose Escalation and Cold-Antibody Sub-Study: Progression free survival (PFS).
Phase 1 and 2
Dose Escalation and Cold-Antibody Sub-Study: Time to Progression (TTP).
Phase 1 and 2
Dose Escalation and Cold-Antibody Sub-Study: Disease control rate (DCR).
Phase 1 and 2
Dose Escalation and Cold-Antibody Sub-Study: Overall survival (OS).
Phase 1 and 2

Full Information

First Posted
November 9, 2018
Last Updated
August 30, 2023
Sponsor
Fusion Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03746431
Brief Title
A Phase 1/2 Study of [225Ac]-FPI-1434 Injection
Official Title
A Phase 1/2 Study of [225Ac]-FPI-1434 Injection in Patients With Locally Advanced or Metastatic Solid Tumours
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2019 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fusion Pharmaceuticals Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
225-Ac Labelled Humanized Monoclonal Antibody Against IGF-1R, [225Ac]-FPI-1434, IGF-IR Targeted Alpha Therapeutic, IGF-IR Radioligand Therapy, Radiopharmaceuticals

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
253 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
[225Ac]-FPI-1434 Single-Dose Escalation
Arm Type
Experimental
Arm Title
[225Ac]-FPI-1434 Multi-Dose Escalation
Arm Type
Experimental
Arm Description
[225Ac]-FPI-1434 treatment with or without pre-administration of FPI-1175 (cold antibody).
Arm Title
FPI-1175 Cold Antibody
Arm Type
Experimental
Arm Title
[225Ac]-FPI-1434 Multi-Dose
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
[111In]-FPI-1547 Injection
Intervention Description
[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.
Intervention Type
Drug
Intervention Name(s)
[225Ac]-FPI-1434 Injection multi-dose
Intervention Description
[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.
Intervention Type
Biological
Intervention Name(s)
FPI-1175 Infusion
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
[225Ac]-FPI-1434 Injection single-dose
Intervention Description
[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.
Primary Outcome Measure Information:
Title
Dose Escalation: Incidence of adverse events (AEs).
Description
Phase 1
Time Frame
Approximately one year post final [225Ac]-FPI-1434 Injection.
Title
Single-Dose Escalation: Incidence of dose limiting toxicities (DLTs).
Description
Phase 1
Time Frame
8 weeks.
Title
Multi-Dose Escalation: Incidence of DLTs.
Description
Phase 1
Time Frame
6 weeks.
Title
Dose Escalation: Incidence of clinically significant clinical laboratory abnormalities.
Description
Phase 1
Time Frame
Approximately one year post final [225Ac]-FPI-1434 Injection.
Title
Dose Escalation: Changes in electrocardiogram (ECG) parameters (PR, QRS, QT, and QTc intervals).
Description
Phase 1
Time Frame
4 weeks post final [225Ac]-FPI-1434 Injection.
Title
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.
Description
Phase 1
Time Frame
Within two weeks of the first [111In]-FPI-1547 Injection.
Title
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.
Description
Phase 1
Time Frame
Within two weeks of the first [111In]-FPI-1547 Injection.
Title
Evaluate anti-tumour activity of [225Ac]-FPI-1434 regimen
Description
Phase 2
Time Frame
Approximately one year post final [225Ac]-FPI-1434 injection.
Title
Objective response rate (ORR) RECIST v1.1.
Description
Phase 2
Time Frame
Approximately one year post final [225Ac]-FPI-1434 Injection.
Secondary Outcome Measure Information:
Title
Dose Escalation and Cold Antibody Sub-Study: Tumour uptake of [111In]-FPI-1547 in selected regions of interest on SPECT/CT images.
Description
Phase 1 and 2
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.
Title
Dose Escalation: Radiation doses for selected organs and whole body both for [111In]-FPI-1547 Injection and [225Ac]-FPI-1434 Injection.
Description
Phase 1 and 2
Time Frame
Within one week of the [111In]-FPI-1547 Injection.
Title
Dose Escalation and Cold-Antibody Sub-Study: Changes in radiation absorbed doses for tumour lesions for [225Ac]-FPI-1434.
Description
Phase 1 and 2
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.
Title
Dose Escalation and Cold-Antibody Sub-Study: Clearance for radioactivity and for the targeting antibody.
Description
Phase 1 and 2
Time Frame
4 weeks post final [225Ac]-FPI-1434 Injection.
Title
Dose Escalation and Cold-Antibody Sub-Study: Area under the curve (AUC) for radioactivity and for the targeting antibody.
Description
Phase 1 and 2
Time Frame
4 weeks post final [225Ac]-FPI-1434 Injection.
Title
Dose Escalation and Cold-Antibody Sub-Study: Cmax for radioactivity and for the targeting antibody.
Description
Phase 1 and 2
Time Frame
4 weeks post final [225Ac]-FPI-1434 Injection.
Title
Dose Escalation and Cold-Antibody Sub-Study: Half-life for radioactivity and for the targeting antibody.
Description
Phase 1 and 2
Time Frame
4 weeks post final [225Ac]-FPI-1434 Injection.
Title
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.
Description
Phase 1
Time Frame
Approximately one year post final [225Ac]-FPI-1434 Injection.
Title
Dose Escalation: Changes in the corrected QT (QTc) interval in milliseconds after [225Ac]-FPI-1434 treatment, compared to baseline.
Description
Phase 1 and 2
Time Frame
Approximately 24 hours from the time of [225Ac]-FPI-1434 Injection administration.
Title
Dose Escalation and Cold-Antibody Sub-Study: Changes in human growth hormone (hGh) following [111In]-FPI-1547 Injection and [225Ac]-FPI-1434 Injection.
Description
Phase 1 and 2
Time Frame
4 weeks post final [225Ac]-FPI-1434 Injection.
Title
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.
Description
Phase 1 and 2
Time Frame
4 weeks post final [225Ac]-FPI-1434 Injection.
Title
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.
Description
Phase 1 and 2
Time Frame
4 weeks post final [225Ac]-FPI-1434 Injection.
Title
Cold Antibody Sub-Study: Incidence of AEs.
Description
Phase 1 and 2
Time Frame
Approximately one year post final [225Ac]-FPI-1434 Injection.
Title
Cold Antibody Sub-Study: Incidence of clinically significant clinical laboratory abnormalities.
Description
Phase 1 and 2
Time Frame
Approximately one year post final [225Ac]-FPI-1434 Injection.
Title
Cold Antibody Sub-Study: Changes in ECG parameters (PR, QRS, QT, and QTc intervals).
Description
Phase 1 and 2
Time Frame
4 weeks post final [225Ac]-FPI-1434 Injection.
Title
Dose Escalation and Cold-Antibody Sub-Study: Time to response (TTR).
Description
Phase 1 and 2
Time Frame
Approximately one year post final [225Ac]-FPI-1434 Injection.
Title
Dose Escalation and Cold-Antibody Sub-Study: Duration of response (DoR).
Description
Phase 1 and 2
Time Frame
Approximately one year post final [225Ac]-FPI-1434 Injection.
Title
Dose Escalation and Cold-Antibody Sub-Study: Progression free survival (PFS).
Description
Phase 1 and 2
Time Frame
Approximately one year post final [225Ac]-FPI-1434 Injection.
Title
Dose Escalation and Cold-Antibody Sub-Study: Time to Progression (TTP).
Description
Phase 1 and 2
Time Frame
Approximately one year post final [225Ac]-FPI-1434 Injection.
Title
Dose Escalation and Cold-Antibody Sub-Study: Disease control rate (DCR).
Description
Phase 1 and 2
Time Frame
Approximately one year post final [225Ac]-FPI-1434 Injection.
Title
Dose Escalation and Cold-Antibody Sub-Study: Overall survival (OS).
Description
Phase 1 and 2
Time Frame
Approximately one year post final [225Ac]-FPI-1434 Injection.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
clinicaltrials@fusionpharma.com
Phone
+1 (888) 506-4215
Email
clinicaltrials@fusionpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Kazakin, MD
Organizational Affiliation
Fusion Pharmaceuticals Inc.
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Masonic Cancer Center, University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Name
Roswell Park Comprehensive Cancer Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Name
Juravinski Cancer Center - Hamilton Health
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C1
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Centre Hospitalier De I'Universite de Montreal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 0C1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Quebec University Hospital- Laval
City
Québec City
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
36383907
Citation
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.
Results Reference
derived

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A Phase 1/2 Study of [225Ac]-FPI-1434 Injection

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