eligibility_summary
Inclusion: histologically/cytologically confirmed advanced/metastatic/recurrent/inoperable solid tumor, progressed after prior therapy with no suitable standard options, measurable disease (RECIST 1.1), ECOG 0–1, adequate organ function. Exclusion: prior systemic radiopharmaceuticals, recent therapy without washout/recovery, imaging contraindications, RT <28 days, uncontrolled effusions needing recurrent drainage, CNS mets unless treated/stable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1 first-in-human study testing three EGFR/cMET-directed agents: 1) [225Ac]-FPI-2068: radiopharmaceutical targeted alpha therapy (Actinium-225 conjugated to FPI-2053, a bispecific monoclonal antibody). Mechanism: binds EGFR and cMET on tumor cells and delivers high-LET alpha radiation, causing DNA double-strand breaks and tumor cell kill. 2) [111In]-FPI-2107: radioimmuno-SPECT imaging agent (Indium-111 on FPI-2053) to assess biodistribution/dosimetry/PK. 3) FPI-2053: unlabeled bispecific antibody used as a predose to optimize targeting. Cells/pathways targeted: EGFR (ErbB1) and MET (cMET/HGF receptor) signaling on EGFR- and/or cMET-expressing solid tumors (HNSCC, NSCLC, mCRC, PDAC, GC, RCC). Study parts: optimize FPI-2053 predose, then escalate [225Ac]-FPI-2068 dose. Safety/tolerability are primary.