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 Operations

clinicaltrials@fusionpharma.com 1 (888) 506-4215

Government Study Link:

NCT06147037 - Click to see study on ClinicalTrials.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

Stanford University Medical Center

Stanford, California 94305, United States