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A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours
Sponsor: AstraZeneca
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
Conditions
Interventions
FPI-2053
FPI-2053 is a bispecific antibody that targets EGFR and cMET
[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).
[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
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Santa Monica, California, United States
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Chicago, Illinois, United States
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Boston, Massachusetts, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Cleveland, Ohio, United States
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Pittsburgh, Pennsylvania, United States
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Houston, Texas, United States
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Seattle, Washington, United States
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Edmonton, Alberta, Canada
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Halifax, Nova Scotia, Canada
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Montreal, Quebec, Canada
Research Site
Sherbrooke, Quebec, Canada