Status:
RECRUITING
A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours
Lead Sponsor:
AstraZeneca
Conditions:
Advanced Solid Tumor
Metastatic Colorectal Carcinoma
Eligibility:
All Genders
18-130 years
Phase:
PHASE1
Brief 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 \[2...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
July 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 12 2028
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06147037
Start Date
July 31 2024
End Date
May 12 2028
Last Update
December 18 2025
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Irvine, California, United States, 92618
2
Research Site
Palo Alto, California, United States, 94304
3
Research Site
Santa Monica, California, United States, 90404
4
Research Site
Chicago, Illinois, United States, 60637