FAPi Radioligand Therapy for Solid Cancers
(FRONTIER Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing two new drugs on patients with specific solid tumors that have high levels of a protein called FAP. The goal is to see if these drugs are safe and to find the best dose for future studies. The drugs work by targeting the FAP protein on the cancer cells.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, if you are on systemic anti-cancer therapy, you must stop it at least 4 weeks before starting the study treatment. Hormone maintenance therapy might be allowed if you are on a stable dose with approval from the medical monitor.
Is FAPi Radioligand Therapy generally safe for humans?
How is the FAPi Radioligand Therapy for Solid Cancers unique compared to other treatments?
The FAPi Radioligand Therapy using [Ga-68]-PNT6555 and [Lu-177]-PNT6555 is unique because it targets fibroblast activation protein (FAP), which is overexpressed in many solid tumors, allowing for precise delivery of radiation to cancer cells. This approach improves tumor retention and selectivity, potentially leading to better outcomes and fewer side effects compared to traditional therapies.23567
What data supports the effectiveness of the treatment [Ga-68]-PNT6555, [Lu-177]-PNT6555 for solid cancers?
Who Is on the Research Team?
Jessica Jensen
Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
Adults with advanced solid tumors (like pancreatic, colorectal, or skin cancer) that resist standard treatments can join this trial. They must have a life expectancy of at least 6 months and be in fairly good health otherwise (ECOG 0-1). Participants need to use two forms of birth control and cannot be pregnant. Those with brain metastases, recent other cancer therapies, severe medical conditions, or certain blood disorders are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive [Lu-177]-PNT6555 for dose escalation to evaluate safety, tolerability, and dosimetry
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Preliminary efficacy of [Lu-177]-PNT6555 based on tumor response and biomarker changes
What Are the Treatments Tested in This Trial?
Interventions
- [Ga-68]-PNT6555
- [Lu-177]-PNT6555
Find a Clinic Near You
Who Is Running the Clinical Trial?
POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company
Lead Sponsor
Eli Lilly and Company
Lead Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
POINT Biopharma
Lead Sponsor