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

Status: Active_not_recruiting
Location: See all (13) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 1
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
City of Hope
Duarte
Massachusetts
Dana-Farber Cancer Institute
Boston
Minnesota
Masonic Cancer Center, University of Minnesota
Minneapolis
New York
Roswell Park Comprehensive Cancer Center
Buffalo
Memorial Sloan Kettering Cancer Center
New York
Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia
Texas
University of Texas MD Anderson Cancer Center
Houston
Other Locations
Australia
Royal Adelaide Hospital
Adelaide
Austin Hospital
Heidelberg
Canada
Juravinski Cancer Center - Hamilton Health
Hamilton
Centre Hospitalier De I'Universite de Montreal
Montreal
Quebec University Hospital- Laval
Québec
Princess Margaret Cancer Centre
Toronto
Time Frame
Start Date: 2019-01-17
Completion Date: 2025-12-14
Participants
Target number of participants: 253
Treatments
Experimental: [225Ac]-FPI-1434 Single-Dose Escalation
Experimental: [225Ac]-FPI-1434 Multi-Dose Escalation
\[225Ac\]-FPI-1434 treatment with or without pre-administration of FPI-1175 (cold antibody).
Experimental: FPI-1175 Cold Antibody
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).
Sponsors
Leads: Fusion Pharmaceuticals Inc.

This content was sourced from clinicaltrials.gov