Actively Recruiting
A Phase 1, First-in-human, Multicentre, Open-label, Dose Escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours
Led by AstraZeneca · Updated on 2026-05-26
70
Participants Needed
15
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety, tolerability, and behavior of three investigational drugs—[225Ac]-FPI-2068, [111In]-FPI-2107, and FPI-2053—in adults with advanced or recurrent solid tumors, including head and neck squamous cell carcinoma, non-small cell lung cancer, metastatic colorectal carcinoma, pancreatic ductal adenocarcinoma, gastric cancer, and renal cell carcinoma. This phase 1, first-in-human, open-label study aims to find the best dose and understand how these drugs distribute and act in the body. The study has two parts: Part A focuses on finding the optimal dose of FPI-2053 combined with a fixed dose of [225Ac]-FPI-2068. Part B then escalates the dose of [225Ac]-FPI-2068 using the chosen FPI-2053 dose from Part A. Participants receive the radiopharmaceutical therapy [225Ac]-FPI-2068 through intravenous administration every 56 days, up to three cycles. Imaging with [111In]-FPI-2107 is used to observe drug distribution, with or without prior FPI-2053. Participants will undergo safety and tolerability assessments from consent until about five years after the last dose. Radiation doses to the whole body and organs are measured within 56 days post-treatment. Researchers will monitor pharmacokinetics, tumor uptake, immunogenicity, and preliminary anti-tumor activity. The study includes regular scans, lab tests, and evaluations to ensure participant safety and understand the investigational drugs’ effects over time.
CONDITIONS
Brief 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 progressed despite prior treatment with no effective standard therapy available, contraindicated, not tolerable, or refused
- Measurable disease per RECIST Version 1.1 criteria
- ECOG Performance status of 0 or 1
- Adequate organ function
- Adults aged 18 to 130 years
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 perform required imaging procedures
- Radiation therapy within 28 days prior to first dose of [111In]-FPI-2107
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage at least once per 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 168 days (3 cycles of 56 days each)
Participants receive intravenous administration of [225Ac]-FPI-2068 every 56 days for up to 3 cycles. The treatment includes dose exploration and dose escalation of [225Ac]-FPI-2068 with FPI-2053 to determine the optimal dosage and safety.
Up to 3 treatment visits every 56 days
Duration - Up to 5 years post last administration
Participants are monitored for safety, tolerability, and preliminary anti-tumor activity for up to approximately 5 years after the last treatment administration.
Periodic visits for safety and efficacy assessments
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
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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