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A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours
NCT06147037 · AstraZeneca
In plain English
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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
About this study
The study will be conducted in 2 parts:
Part A: optimization of the FPI-2053 dose (treatment with dose level 1 of \[225Ac\]-FPI-2068 - fixed dose).
Part B: dose escalation of \[225Ac\]-FPI-2068 with optimal FPI-2053. Part B will commence once the optimal dose of FPI-2053 is determined in Part A. The RP2D will be determined from Part B based on all available safety, efficacy, PK, and dosimetry information.
Eligibility criteria
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
Study design
Enrollment target: 70 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-07-31
Estimated completion: 2028-05-12
Last updated: 2026-04-02
Interventions
Drug: FPI-2053Drug: [111In]-FPI-2107Drug: [225Ac]-FPI-2068
Primary outcomes
- • Evaluate safety and tolerability of [111In]-FPI-2107, FPI-2053, and [225Ac]-FPI-2068 (From informed consent up to approximately 5 years post last administration)
- • Determine radiation dose of [111In]-FPI-2107 and [225Ac]-FPI-2068 to whole body, organs, and selected regions of interest. (Within 56 days of administration)
- • Determine the RP2D of [225Ac]-FPI-2068, given with or without FPI-2053 (56 days post administration)
Sponsor
AstraZeneca · industry
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
All locations (15)
Research SiteWithdrawn
Irvine, California, United States
Research SiteRecruiting
Palo Alto, California, United States
Research SiteNot Yet Recruiting
Santa Monica, California, United States
Research SiteRecruiting
Chicago, Illinois, United States
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Boston, Massachusetts, United States
Research SiteWithdrawn
St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Cleveland, Ohio, United States
Research SiteWithdrawn
Pittsburgh, Pennsylvania, United States
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Houston, Texas, United States
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Seattle, Washington, United States
Research SiteNot Yet Recruiting
Edmonton, Alberta, Canada
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Halifax, Nova Scotia, Canada
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Montreal, Quebec, Canada
Research SiteRecruiting
Sherbrooke, Quebec, Canada