[225Ac]-FPI-2068 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new treatments for various difficult-to-treat cancers, such as head and neck, lung, and pancreatic cancer, that have spread or recurred after treatment. The main goal is to determine the safety of these treatments and how the body processes them. The trial is divided into two parts to identify the best dose for one treatment, [225Ac]-FPI-2068, a new potential drug. Eligible participants have cancers that did not respond to other treatments and have no better options available. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it mentions that you must have an adequate washout period from prior anti-cancer therapy. This means you might need to stop certain treatments for a while before starting the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that [225Ac]-FPI-2068 is undergoing its first human trials. The studies focus on its safety and tolerability. As a Phase 1 trial, the primary goal is to determine the treatment's safety for patients. Early results indicate that researchers are still identifying possible side effects.
Similarly, FPI-2053 is under study for safety and tolerability. As this research is in its early stages, detailed information on side effects is still being collected.
Both treatments are in Phase 1 trials, marking the beginning of human testing. These trials typically involve a small number of participants to identify any negative effects and ensure the treatment's safety. This initial step in testing new treatments aims to ensure that any side effects are manageable and not severe.12345Why are researchers excited about this trial's treatments?
Researchers are excited about [225Ac]-FPI-2068 because it offers a novel approach to treating cancer by utilizing a targeted radioligand therapy. Unlike traditional chemotherapy, which can affect both healthy and cancerous cells, [225Ac]-FPI-2068 specifically targets cancer cells, potentially reducing side effects and improving treatment precision. Additionally, the use of the radioisotope Actinium-225 allows for high-energy alpha particle emission, which can effectively damage cancer cells with fewer impacts on surrounding healthy tissue. This targeted mechanism sets it apart from conventional cancer treatments and holds promise for more effective and safer cancer therapy.
What evidence suggests that this trial's treatments could be effective for metastatic and/or recurrent solid tumors?
Research has shown that [225Ac]-FPI-2068 could be promising for treating certain cancers. This treatment targets cancer cells by focusing on specific proteins, EGFR and cMET, which are more prevalent in tumors. It delivers radiation directly to these cells, destroying them while sparing healthy tissue. Early studies suggest it can effectively target and kill cancer cells.
In this trial, researchers are studying FPI-2053 in combination with [225Ac]-FPI-2068. FPI-2053 is designed to enhance the main treatment's ability to reach cancer cells, aiming to increase its impact on tumors. Both treatments are still under investigation in this trial, but they offer a new approach to tackling hard-to-treat cancers.12678Who Is on the Research Team?
Lorraine Hughes, MS
Principal Investigator
Fusion Pharmaceuticals Inc.
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors like certain cancers of the mouth, pancreas, lung, and colorectal regions. Participants must have a confirmed diagnosis with disease progression after prior treatments and no available or suitable standard therapy options. They should be relatively active (good performance status) and have organs functioning well enough to handle the trial.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Exploration (Part A)
Optimization of the FPI-2053 dose with a fixed dose of [225Ac]-FPI-2068
Dose Escalation (Part B)
Dose escalation of [225Ac]-FPI-2068 with optimal FPI-2053
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- [111In]-FPI-2107
- [225Ac]-FPI-2068
- FPI-2053
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Fusion Pharmaceuticals Inc.
Lead Sponsor