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RECRUITING
NCT06147037
PHASE1

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

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).

Official title: A Phase 1, First-in-human, Multicentre, Open-label, Dose Escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours

Key Details

Gender

All

Age Range

18 Years - 130 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2024-07-31

Completion Date

2028-05-12

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

DRUG

FPI-2053

FPI-2053 is a bispecific antibody that targets EGFR and cMET

DRUG

[111In]-FPI-2107

\[111In\]-FPI-2107 is an imaging agent in which indium-111 is conjugated to FPI-2053. Participants will have a fixed dose of \[111In\]-FPI-2107 followed by imaging scans (with or without pre-administration of FPI-2053).

DRUG

[225Ac]-FPI-2068

\[225Ac\]-FPI-2068 is a radiopharmaceutical therapy in which an alpha emitter, actinium-225, is conjugated to FPI-2053. Participants will be dosed through IV administration every 56 days for up to 3 cycles of the Treatment Period.

Locations (15)

Research Site

Irvine, California, United States

Research Site

Palo Alto, California, United States

Research Site

Santa Monica, California, United States

Research Site

Chicago, Illinois, United States

Research Site

Boston, Massachusetts, United States

Research Site

St Louis, Missouri, United States

Research Site

Omaha, Nebraska, United States

Research Site

Cleveland, Ohio, United States

Research Site

Pittsburgh, Pennsylvania, United States

Research Site

Houston, Texas, United States

Research Site

Seattle, Washington, United States

Research Site

Edmonton, Alberta, Canada

Research Site

Halifax, Nova Scotia, Canada

Research Site

Montreal, Quebec, Canada

Research Site

Sherbrooke, Quebec, Canada