177Lu-FAP-2286 for Solid Cancers
(LuMIERE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called 177Lu-FAP-2286, a radiopharmaceutical therapy, for individuals with certain types of solid tumors. The goal is to assess the safety and efficacy of this treatment, particularly for pancreatic, lung, and breast cancers. The first part of the trial tests different doses to identify the safest one, while the second part evaluates its effectiveness both alone and with chemotherapy. Participants should have a solid tumor resistant to other treatments and must have tumors expressing a specific protein called FAP, verified through imaging. This trial may suit those whose cancer has not responded to standard therapies and who have specific types of pancreatic, lung, or breast cancer. As a Phase 1, Phase 2 trial, this study aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you should discuss your current medications with the study team to ensure they don't interfere with the trial treatments.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you should not have received certain anticancer treatments within 14 to 28 days before starting the trial, depending on the type of treatment. It's best to discuss your current medications with the trial team to ensure they don't interfere with the study.
Is there any evidence suggesting that 177Lu-FAP-2286 is likely to be safe for humans?
Research has shown that 177Lu-FAP-2286 has generally been well-tolerated in earlier studies. In these studies, participants with various advanced or metastatic solid tumors received the treatment, and early results indicated its safety. While some side effects occurred, they were mostly mild to moderate and manageable, such as tiredness or nausea, which are common with many cancer treatments.
This treatment remains in the early testing phase, which aims to ensure safety and determine the correct dosage for future studies. So far, the safety results appear promising, but ongoing studies will continue to monitor and gather more information about its safety.12345Why are researchers excited about this study treatment?
Researchers are excited about 177Lu-FAP-2286 because it introduces a new way to target solid tumors. Unlike traditional therapies that often affect both healthy and cancerous cells, 177Lu-FAP-2286 specifically targets fibroblast activation protein (FAP), which is commonly found in cancerous tumors. This precision targeting could potentially minimize damage to healthy tissues and improve treatment outcomes. Additionally, the use of the radioactive isotope Lutetium-177 allows for both imaging and treatment, providing a dual benefit in managing cancer. These unique features make 177Lu-FAP-2286 a promising option for patients with solid tumors.
What evidence suggests that 177Lu-FAP-2286 might be an effective treatment for solid cancers?
Research has shown that 177Lu-FAP-2286 holds promise for treating solid cancers. It targets fibroblast activation protein (FAP), commonly found in tumors but not in normal tissues, allowing it to attack cancer cells while sparing healthy ones. Studies indicate it has a manageable safety profile, causing few serious side effects. In this trial, participants will join different phases: the Phase 1 Dose Escalation arm will include up to 30 patients with solid tumors, while the Phase 2 arm will treat up to 192 participants with 177Lu-FAP-2286 in tumor-specific groups, both as monotherapy and in combination with chemotherapy. Early results from patients with advanced tumors suggest it could be a hopeful treatment option.12567
Who Is on the Research Team?
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors that have worsened after treatment or don't respond to it. They should be in good physical condition, not pregnant, and willing to use contraception. People with active secondary cancers, brain metastases, recent cancer treatments or surgeries, ongoing serious side effects from past treatments (except hair loss), severe urinary issues, known allergies to scan contrast media, infections needing antibiotics recently, significant heart problems 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 a single IV dose of [177Lu]Lu FAP 2286 every 6 weeks in Phase 1 and every 4 weeks in Phase 2, up to a maximum of 6 doses
End of Treatment (EOT) Visit
Participants have an EOT visit 6-8 weeks after the last dose in Phase 1 and within 28 days in Phase 2
Post Treatment Safety Follow-up
Participants undergo safety follow-up for 6 weeks after discontinuation of study treatment
Long-term Follow-up (LTFU) Period
Participants are monitored for safety, disease, and survival assessments every 12 weeks for 2 years, then every 6 months until 5 years
What Are the Treatments Tested in This Trial?
Interventions
- 177Lu-FAP-2286
Find a Clinic Near You
Who Is Running the Clinical Trial?
Clovis Oncology, Inc.
Lead Sponsor
Patrick J. Mahaffy
Clovis Oncology, Inc.
Chief Executive Officer since 2009
BA from Haverford College, MBA from Columbia University
Lindsey Rolfe
Clovis Oncology, Inc.
Chief Medical Officer since 2015
Specialist accreditation in pharmaceutical medicine
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD