Actively Recruiting
A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours
Led by AstraZeneca · Updated on 2026-04-28
70
Participants Needed
15
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically and/or cytologically confirmed metastatic, locally advanced, recurrent, or inoperable solid tumor
- Disease progression despite prior treatment and no available or suitable standard therapy
- Measurable disease according to RECIST Version 1.1
- ECOG Performance status of 0 or 1
- Adequate organ function
You will not qualify if you...
- Previous treatment with any systemic radiopharmaceutical
- Prior anti-cancer therapy without adequate washout and recovery from toxicities
- Contraindications to or inability to undergo required imaging procedures
- Radiation therapy within 28 days before first dose of [111In]-FPI-2107
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage at least once a month
- Known central nervous system metastatic disease unless treated and stable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Research Site
Irvine, California, United States, 92618
Withdrawn
2
Research Site
Palo Alto, California, United States, 94304
Actively Recruiting
3
Research Site
Santa Monica, California, United States, 90404
Not Yet Recruiting
4
Research Site
Chicago, Illinois, United States, 60637
Actively Recruiting
5
Research Site
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
Research Site
St Louis, Missouri, United States, 63110
Withdrawn
7
Research Site
Omaha, Nebraska, United States, 68130
Actively Recruiting
8
Research Site
Cleveland, Ohio, United States, 44195
Actively Recruiting
9
Research Site
Pittsburgh, Pennsylvania, United States, 15237
Withdrawn
10
Research Site
Houston, Texas, United States, 77030
Actively Recruiting
11
Research Site
Seattle, Washington, United States, 98109
Actively Recruiting
12
Research Site
Edmonton, Alberta, Canada, T6G 1Z2
Not Yet Recruiting
13
Research Site
Halifax, Nova Scotia, Canada, B3H 2Y9
Actively Recruiting
14
Research Site
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
15
Research Site
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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