Investigating a new treatment for advanced solid tumors
A Phase 1, First-in-human, Multicentre, Open-label, Dose Escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours
This study is testing a new treatment for adults with advanced solid tumors to see if it is safe and how much of it should be used.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 130 Years |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | Radiation |
| Locations | 15 sites (Irvine, California and 14 other locations) |
| Trial ID | NCT06147037 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical study aims to evaluate the safety and tolerability of a novel treatment, [225Ac]-FPI-2068, in adult patients with advanced solid tumors, including metastatic colorectal carcinoma, head and neck squamous cell carcinoma, non-small cell lung cancer, and pancreatic ductal adenocarcinoma. The study is divided into two parts: the first part focuses on optimizing the dose of FPI-2053, while the second part involves dose escalation of [225Ac]-FPI-2068 based on the findings from the first part. The study will assess various factors including dosimetry, biodistribution, and pharmacokinetics to determine the recommended phase 2 dose (RP2D).
Who should consider this trial
Good fit: Ideal candidates include adults with histologically confirmed metastatic or recurrent solid tumors that have progressed despite prior treatments.
Not a fit: Patients with known CNS metastatic disease that is not treated and stable, or those who have received systemic radiopharmaceuticals previously, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.
How similar studies have performed: While this approach is novel, similar studies involving targeted radiopharmaceuticals have shown promise in treating advanced cancers.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Irvine, California and 14 other locations
- Research Site — Irvine, California, United States (Withdrawn)
- Research Site — Palo Alto, California, United States (Recruiting)
- Research Site — Santa Monica, California, United States (Not_yet_recruiting)
- Research Site — Chicago, Illinois, United States (Recruiting)
- Research Site — Boston, Massachusetts, United States (Recruiting)
- Research Site — St Louis, Missouri, United States (Withdrawn)
- Research Site — Omaha, Nebraska, United States (Recruiting)
- Research Site — Cleveland, Ohio, United States (Recruiting)
- Research Site — Pittsburgh, Pennsylvania, United States (Withdrawn)
- Research Site — Houston, Texas, United States (Recruiting)
- Research Site — Seattle, Washington, United States (Recruiting)
- Research Site — Edmonton, Alberta, Canada (Not_yet_recruiting)
- Research Site — Halifax, Nova Scotia, Canada (Recruiting)
- Research Site — Montreal, Quebec, Canada (Recruiting)
- Research Site — Sherbrooke, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.