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Fusion announced that it is discontinuing this study as part of a portfolio prioritization and assessment; Fusion no longer plans to pursue development of FPI-1966.
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This first-in-human study evaluates safety, tolerability and distribution of [225Ac] FPI-1966, [111In]-FPI-1967, and vofatamab in patients with FGFR3-expressing solid tumors.
In phase 1, cohort 1, the potential impact of pre-dose administration of vofatamab on the dosimetry, PK, safety, and tolerability of [225Ac]-FPI-1966 and [111In]-FPI-1967 will be evaluated.
In later phase 1 cohorts, [225Ac]-FPI-1966 will be evaluated at ascending dose levels. Participants will receive [111In]-FPI-1967 during the imaging screening period to assess FGFR3 expression and to determine biodistribution and estimate radiation exposure to critical organs.
Once the recommended phase 2 dose (RP2D) or regimen is established and confirmed, three tumour-agnostic expansion cohorts may be initiated in parallel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 | Experimental | Depending on assigned cohort, [In111]-FPI-1967/[225Ac]-FPI-1966 will be administered with or without pre-dosing with vofatamab. |
|
| Phase 2 | Experimental | Depending on assigned cohort, [In111]-FPI-1967/[225Ac]-FPI-1966 will be administered either with or without pre-administration of vofatamab, depending on the RP2D/regimen as determined in the phase 1 portion of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [225Ac]-FPI-1966 | Drug | [225Ac]-FPI-1966 is a targeted alpha therapeutic that consists of vofatamab, a bifunctional chelate, and actinium-225, an alpha particle emitting radionuclide. In Phase 1, the dose depends on cohort assignment. In Phase 2, the RP2D regimen will be administered. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Phase 1: Incidence of AEs to evaluate safety and tolerability of [225Ac]-FPI-1966, [111In]-FPI-1967, and vofatamab. | Approximately 2 years post final administration | |
| Phase 1: Maximum tolerated dose (MTD) of [225Ac]-FPI-1966 | Approximately 42 days post administration. | |
| Phase 1: Radiation dose of [111In]-FPI-1967 and [225Ac]-FPI-1966 (whole body, organs, and selected regions of interest) | Within one week of administration | |
| Phase 1: Effect of pre-dose administration of vofatamab on the radiation dosimetry of [111In]-FPI-1967 and [225Ac]-FPI-1966. | Within one week of administration | |
| Phase 2: Objective response rate (ORR) (sum of complete and partial response) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. | Up to two years post final administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 and 2: Anti-tumour activity of [225Ac]-FPI-1966 regimen measured by response per RECIST v1.1 | Approximately 2 years post final administration | |
| Phase 1 and 2: Tumour uptake of [111In]-FPI-1967 by evaluating SPECT/CT and/or planar images | Within one week of administration |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia Kazakin, MD | Fusion Pharmaceuticals Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| University of California, San Francisco |
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| Label | URL |
|---|---|
| Sponsor website | View source |
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|
| [111In]-FPI-1967 | Drug | [111In]-FPI-1967 is an imaging agent that consists of vofatamab, a bifunctional chelate and indium-111 radionuclide. Participants will receive [111In]-FPI-1967 Injection of 185 MBq for imaging. |
|
| vofatamab | Biological | Vofatamab is a Fibroblast Growth Factor Receptor 3 (FGFR3)-targeting human monoclonal antibody without a radioisotope. In Phase 1, the dose depends on cohort assignment. In Phase 2, if pre-dosing with vofatamab is indicated, the RP2D regimen will be administered. |
|
| Phase 2: Radiation dose of [111In]-FPI-1967 and [225Ac]-FPI-1966 (whole body, organs, and selected regions of interest) | Within one week of administration |
| Phase 1 and 2: Clearance for radioactivity and for the targeting antibody. | 28 days post final [225Ac]-FPI-1966administration |
| Phase 1 and 2: Area under the curve (AUC) for radioactivity and targeting antibody | 28 days post final [225Ac]-FPI-1966administration. |
| Phase 1 and 2: Maximum concentration after dosing (Cmax) for radioactivity and targeting antibody. | 28 days post final[225Ac]-FPI-1966 administration |
| Phase 1 and 2: Half-life for radioactivity and targeting antibody. | 28 days post final [225Ac]-FPI-1966 administration |
| Phase 1: Changes in clearance for radioactivity and targeting antibody following pre-dose administration of vofatamab | 28 days post final [225Ac]-FPI-1966 administration |
| Phase 1: Changes in AUC for radioactivity and targeting antibody following pre-dose administration of vofatamab. | 28 days post final [225Ac]-FPI-1966 administration |
| Phase 1: Changes in Cmax for radioactivity and targeting antibody following pre-dose administration of vofatamab. | 28 days post final [225Ac]-FPI-1966 administration |
| Phase 1: Changes in half-life for radioactivity and targeting antibody following pre-dose administration of vofatamab | 28 days post final [225Ac]-FPI-1966 administration |
| San Francisco |
| California |
| 94143 |
| United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| GC Murdoch | Murdoch | Western Australia | 6150 | Australia |
| St Vincent's Hospital | Melbourne | Australia |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 3, 2024 | Jul 29, 2024 | 8 | ||
| Nov 25, 2024 | Dec 18, 2024 | 9 | ||
| Feb 5, 2025 | Feb 25, 2025 | 10 |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D001749 | Urinary Bladder Neoplasms |
| D010051 | Ovarian Neoplasms |
| D015179 | Colorectal Neoplasms |
| D001943 | Breast Neoplasms |
| D008113 | Liver Neoplasms |
| D008175 | Lung Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D005833 | Genital Neoplasms, Female |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008107 | Liver Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| C573866 | vofatamab |
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