Study Title
A Phase 1, First-in-human, Multicentre, Open-label, Dose Escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours
Study Details
Description:
This is a first-in-human, Phase 1, non-randomized, multicenter, open-label clinical study designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics (PK) of [225Ac]-FPI-2068, [111In]-FPI-2107, and FPI-2053 in metastatic and/or recurrent solid tumors (HNSCC, NSCLC, mCRC, PDAC).
Sponsor:
Fusion Pharmaceuticals, Inc.Contacts:
Clinical Trials Fusion Pharmaceuticals Clinical Operationsclinicaltrials@fusionpharma.com
1 (888) 506-4215
Government Study Link:
NCT06147037 - Click here to see study onClinicalTrials.gov
Inclusion
- Adequate organ function
- Histologically/cytologically confirmed solid tumor, metastatic, locally advanced recurrent or inoperable
- Measurable diseases as defined by RECIST v1.1
- Progressed disease despite treatment, standard therapy not available contradicted not tolerable or no standard therapy
- ECOG performance status 0 or 1
Exclusion
- Prior anti-cancer therapy unless adequate washout and recovery from toxicities
- Previous treatment with any systemic radiopharmaceutical
- Uncontrolled pleural effusion, pericardial effusion, ascites requiring drainage
- Contraindications to or inability perform the imaging procedures required in study
- Radiation therapy within 28 days prior to the first dose of Indium
Patient Education
Patient Education Not Yet Provided
Publications
Publications Not Yet Provided
Locations
United States