NCT06147037Active, not recruitingPhase 1
A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours
A Phase 1, First-in-human, Multicentre, Open-label, Dose Escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 13 (actual)
- First submitted
- 20 Nov 2023
- Start date
- 31 Jul 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- AstraZeneca
- Diseases
- Head and neck cancer, Kidney cancer, Lung cancer, Pancreatic cancer, Colorectal cancer, Gastric and esophageal cancer
- NCT number
- NCT06147037
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 13
- From 31 Jul 2024 to the primary completion date, 31 Dec 2026
- 8 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with any systemic radiopharmaceutical
- Prior anti-cancer therapy unless adequate washout and recovery from toxicities
- Radiation therapy (RT) within 28 days prior to the first dose of \[111In\]-FPI-2107
Other illness
- Patients with known CNS metastatic disease unless treated and stable
Other
- Contraindications to or inability to perform the imaging procedures required in this study
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (≥ once per month)
Who the study is looking for
- 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
Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Sherbrooke | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.