A Study of [225Ac]-FPI-2059 in Adult Participants With Solid Tumours
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| ClinicalTrials.gov Identifier: NCT05605522 |
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Recruitment Status :
Recruiting
First Posted : November 4, 2022
Last Update Posted : April 5, 2024
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pancreatic Ductal Adenocarcinoma (PDAC) Squamous Cell Carcinoma of Head and Neck Colorectal Cancer Gastric Cancer Ewing Sarcoma NTSR1 Expressing Solid Tumours Neuroendocrine Differentiated (NED) Prostate Cancer | Drug: [225]-FPI-2059 Drug: [111In]-FPI-2058 | Phase 1 |
This is a first-in-human, Phase 1, non-randomized, multi-centre, open-label clinical trial designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics (PK) of [225Ac]-FPI-2059 and [111In]-FPI-2058, as well as the pharmacodynamics and preliminary anti-tumour activity of [225Ac]-FPI-2059 in participants with neurotensin receptor 1 (NTSR1)-expressing advanced, metastatic and/or recurrent solid tumours.
The study will employ a 3+3 dose escalation design to identify the recommended phase 2 dose (RP2D) and regimen of [225Ac]-FPI-2059 administered intravenously every 56 days.
After the RP2D for [225Ac]-FPI-2059 is determined, enrolment will continue into an expansion cohort, to confirm the safety and tolerability of the RP2D, as well as to identify any preliminary evidence of efficacy in selected NTSR1-expressing tumour types.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 42 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1 Study of [225Ac]-FPI-2059 in Adult Participants With NTSR1-Expressing Advanced, Metastatic and/or Recurrent Solid Tumours |
| Actual Study Start Date : | February 7, 2023 |
| Estimated Primary Completion Date : | June 2025 |
| Estimated Study Completion Date : | September 2025 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Phase 1 Dose Escalation |
Drug: [225]-FPI-2059
[225Ac]-FPI-2059 is a targeted alpha therapeutic that consists of an NTSR1-targeting small molecule that is linked to Ac-225, an alpha particle emitting radionuclide. Participants will be dosed through IV administration every 56 days up to four cycles. The dose depends on cohort assignment. In the Dose Expansion arm, [225Ac]-FPI-2059 will be administered at the RP2D as determined in Phase 1 Dose Escalation. Drug: [111In]-FPI-2058 [111In]-FPI-2058 is an imaging agent that consists of an NTSR1-targeting small molecule linked to In-111.Participants will receive [111In]-FPI-2058 by IV Injection for imaging once during screening period. The dose is consistent across cohorts. |
| Experimental: Phase 1 Dose Expansion |
Drug: [225]-FPI-2059
[225Ac]-FPI-2059 is a targeted alpha therapeutic that consists of an NTSR1-targeting small molecule that is linked to Ac-225, an alpha particle emitting radionuclide. Participants will be dosed through IV administration every 56 days up to four cycles. The dose depends on cohort assignment. In the Dose Expansion arm, [225Ac]-FPI-2059 will be administered at the RP2D as determined in Phase 1 Dose Escalation. Drug: [111In]-FPI-2058 [111In]-FPI-2058 is an imaging agent that consists of an NTSR1-targeting small molecule linked to In-111.Participants will receive [111In]-FPI-2058 by IV Injection for imaging once during screening period. The dose is consistent across cohorts. |
- Incidence of Adverse Events to evaluate safety and tolerability of [225Ac]-FPI-2059 and [111In]-FPI-2058 [ Time Frame: approximately 5 years post final administration ]
- Maximum tolerated dose (MTD) of [225Ac]-FPI-2059 [ Time Frame: 56 days post administration ]
- Radiation dose of [111In]-FPI-2058 and [225Ac]-FPI-2059 to whole body, organs, and selected regions of interest [ Time Frame: within 56 days of administration ]
- Anti-tumor activity of [225Ac]-FPI-2059 regimen measured by response per RECIST v1.1 [ Time Frame: approximately 5 years post final administration ]
- Tumor uptake of [111In]-FPI-2058 by evaluating SPECT/CT and planar images [ Time Frame: within 56 days of administration ]
- Pharmacokinetics (PK) of [225Ac]-FPI-2059 and [111In]-FPI-2059 by measuring changes in clearance, AUC, Cmax, and half-life [ Time Frame: approximately 36 days of final administration ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Signed ICF prior to initiation of any study-specific procedures
- Histologically and/or cytologically confirmed solid tumor that is metastatic or locally advanced, inoperable, or recurrent. Solid tumors indications may include PDAC, CRC, NED prostate cancer, gastric cancer, SCCHN, and Ewing sarcoma.
- Disease that has progressed despite prior treatment, and for which additional effective standard therapy is not available or is contraindicated, not tolerable, or the patient refuses standard therapy
- Measurable disease per RECIST v.1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Sufficient target expression in at least one measurable lesion as determined by imaging following injection of [111In]-FPI-2058
- Adequate organ function
- Tumor tissue (either archival within the last 24 months or fresh biopsy)
Key Exclusion Criteria:
- Previous treatment with any radiopharmaceutical
- Contraindications to or inability to perform the imaging procedures required in this study
- Anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal therapy, targeted therapy, or investigational agents within certain amount of time prior to administration of the first dose of [111In]-FPI-2058
- Radiation therapy (RT) within 28 days prior to the first dose of [111In]-FPI-2058
- Patients with known CNS metastatic disease
- Concurrent severe and/or uncontrolled illness that would limit compliance with study requirements
- Known or suspected allergies or contraindication to the investigational treatment
- Received any type of vaccine within 30 days prior to the first dose of [111In]-FPI-2058
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05605522
| Contact: Clinical Trials Fusion Pharmaceuticals | 1 (888) 506-4215 | clinicaltrials@fusionpharma.com |
| United States, Alabama | |
| University of Alabama at Birmingham Hospital | Recruiting |
| Birmingham, Alabama, United States, 35249 | |
| United States, California | |
| City of Hope Medical Center | Recruiting |
| Duarte, California, United States, 91010 | |
| Hoag Family Cancer Institute | Recruiting |
| Newport Beach, California, United States, 92663 | |
| United States, Kentucky | |
| University of Kentucky | Recruiting |
| Lexington, Kentucky, United States, 40536 | |
| United States, Maryland | |
| Advanced Molecular Imaging and Therapy | Recruiting |
| Glen Burnie, Maryland, United States, 21061 | |
| United States, Missouri | |
| Washington University | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| XCancer Omaha / Urology Cancer Center | Recruiting |
| Omaha, Nebraska, United States, 68130 | |
| Contact: Luke Nordquist, Dr. 402-991-8468 Drnordquistguresearch@gucancer.com | |
| Contact: Tony Romero (402) 697-2229 tony@xcancer.com | |
| Australia, New South Wales | |
| Westmead Hospital | Recruiting |
| Sydney, New South Wales, Australia, 2145 | |
| Study Director: | Joanne Schindler, MD, DVM | Fusion Pharmaceuticals Inc. |
| Responsible Party: | Fusion Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT05605522 |
| Other Study ID Numbers: |
FPI-2059-101 |
| First Posted: | November 4, 2022 Key Record Dates |
| Last Update Posted: | April 5, 2024 |
| Last Verified: | April 2024 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Solid Tumor FPI-2059 FPI-2058 Pancreas Prostate Neuroendocrine Stomach cancer Gastric |
Ewing sarcoma HNSCC Squamous cell carcinoma CRC Colorectal actinium targeted alpha therapy radiopharmaceuticals |
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Carcinoma, Squamous Cell Sarcoma Sarcoma, Ewing Squamous Cell Carcinoma of Head and Neck Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms by Site Neoplasms, Squamous Cell Neoplasms, Connective and Soft Tissue Osteosarcoma Neoplasms, Bone Tissue Neoplasms, Connective Tissue Head and Neck Neoplasms |