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Clinical Trial · NCT05605522
A Study of [225Ac]-FPI-2059 in Adult Participants With Solid Tumours
Overview
This is a first-in-human Phase 1 clinical trial designed to investigate the safety, tolerability, pharmacokinetics, and biodistribution of \[225Ac\]-FPI-2059 and \[111In\]-FPI-2058 in participants with neurotensin receptor 1 (NTSR1)-expressing solid tumours.
Sponsor
Var2 Pharmaceuticals
Phase
Phase 1
Contacts
Aaron Enke (STUDY_DIRECTOR)
ClinicalTrials.gov
NCT05605522Drug / Compound
FPI-2058
Isotope(s):
INDIUM-111
Radioisotope: In-111
Theranostic Role: SPECT Imaging
T1/2 (Half-Life): 2.8 Days
Decay Mode: ELECTRON CAPTURE, GAMMA
Energy: 173 keV, 247 keV
Range: N/A
Decay Daughters: Cd111 (Stable)
Status: FDA Approvals: ONCOSCINT® (1992), OCTREOSCAN® (1994)
Target(s):
- NTSR-1
Ligand Class: Small Molecules
FPI-2059
Isotope(s):
ACTINIUM-225
Radioisotope: Ac-225
Theranostic Role: Therapeutic Agent & SPECT Imaging
T1/2 (Half-Life): 9.9 Days
Decay Mode: ALPHA, GAMMA
Energy: 5.8-8.4 MeV
Range: 47-85 micrometers
Decay Daughters: Ra225, Fr221, At217, Bi213, 209, Po213, 209, TL209, 205
Status: Clinical Trials Only
Target(s):
- NTSR-1
Ligand Class: Small Molecules
Eligibility
Inclusion
- Measurable disease per RECIST v.1.1
- 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.
- Tumor tissue (either archival within the last 24 months or fresh biopsy)Key
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- 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
- Sufficient target expression in at least one measurable lesion as determined by imaging following injection of \[111In\]-FPI-2058
- Adequate organ function
Exclusion
- Concurrent severe and/or uncontrolled illness that would limit compliance with study requirements
- Previous treatment with any radiopharmaceutical
- Contraindications to or inability to perform the imaging procedures required in this study
- Received any type of vaccine within 30 days prior to the first dose of \[111In\]-FPI-2058
- Patients with known CNS metastatic disease
- Known or suspected allergies or contraindication to the investigational treatment
- Radiation therapy (RT) within 28 days prior to the first dose of \[111In\]-FPI-2058
- 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
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