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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
13
Start Date
2024-07-31
Completion Date
2026-12-31
Last Updated
2026-07-07
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 (8)
Research Site
Palo Alto, California, United States
Research Site
Chicago, Illinois, United States
Research Site
Omaha, Nebraska, United States
Research Site
Cleveland, Ohio, United States
Research Site
Houston, Texas, United States
Research Site
Seattle, Washington, United States
Research Site
Montreal, Quebec, Canada
Research Site
Sherbrooke, Quebec, Canada