Active Not RecruitingPhase 1NCT06147037

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).

Checked against the public recordLast updated Jul 7, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 1
U.S. locations8
SponsorAstraZeneca
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
AstraZeneca
Interventions being studied
Drug: FPI-2053; Drug: [111In]-FPI-2107; Drug: [225Ac]-FPI-2068
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Key Inclusion 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, not tolerable, or the participant refuses standard therapy. Measurable disease as defined by RECIST Version 1.1 ECOG Performance status of 0 or 1 Adequate organ function Key Exclusion Criteria: Previous treatment with any systemic radiopharmaceutical Prior anti-cancer therapy unless adequate washout and recovery from toxicities Contraindications to or inability to perform the imaging procedures required in this study Radiation therapy (RT) within 28 days prior to the first dose of \[111In\]-FPI-2107 Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (≥ once per month) Patients with known CNS metastatic disease unless treated and stable

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Research SitePalo Alto, California
  • Research SiteChicago, Illinois
  • Research SiteOmaha, Nebraska
  • Research SiteCleveland, Ohio
  • Research SiteHouston, Texas
  • Research SiteSeattle, Washington
  • Research SiteMontreal, Quebec
  • Research SiteSherbrooke, Quebec

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 7, 2026. Always confirm current availability with the study team.

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