A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours

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, GC, RCC).

Trial Details

NCT ID
NCT06147037
Phase
PHASE1
Sponsor
AstraZeneca
Status
RECRUITING
Cancer Type
Adenocarcinoma Lung Cancer
Interventions
  • FPI-2053
  • [111In]-FPI-2107
  • [225Ac]-FPI-2068
Locations (sample)
  • Irvine, California, United States|33.66946,-117.82311
  • Palo Alto, California, United States|37.44188,-122.14302
  • Santa Monica, California, United States|34.01949,-118.49138
  • Chicago, Illinois, United States|41.85003,-87.65005
  • Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility Criteria

  • Histologically and/or cytologically confirmed solid tumor that is metastatic, locally advanced, recurrent or inoperable.
  • Disease that has progressed despite prior treatment, and for which additional effective standard therapy is not available or is contraindicated, no…
  • Measurable disease as defined by RECIST Version 1.1
  • ECOG Performance status of 0 or 1

For full eligibility, visit ClinicalTrials.gov.

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