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Radioisotope Therapy
177Lu-FAP-2286 for Solid Cancers (LuMIERE Trial)
Phase 1 & 2
Recruiting
Led By Thomas Hope, MD
Research Sponsored by Clovis Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For Phase 2: Have cytologically or histologically and radiologically confirmed recurrent or metastatic disease as outlined
Be ≥ 18 years of age at the time the ICF is signed
Must not have
Impaired cardiac function or clinically significant cardiac diseases
Active malignancy except for the specific cancer under investigation in this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of study drug through at least 6-8 weeks after end of treatment (up to approximately 2 years)
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new drug, [177Lu]Lu FAP 2286, which targets a specific protein on cancer cells and delivers radiation to kill them. It focuses on patients with certain types of cancer that have this protein. The goal is to see if the drug is safe and effective.
Who is the study for?
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.
What is being tested?
The study tests the safety and ideal dose of a new drug called 177Lu-FAP-2286 in Phase 1 and its effectiveness at shrinking tumors in Phase 2. Patients must have specific FAP-expressing tumor types for Phase 2. The response rate will be measured using standard criteria.
What are the potential side effects?
Possible side effects include reactions related to bone marrow suppression (like anemia), liver or kidney function impairment due to the drug's toxicity profile; however exact side effects aren't listed as this is a phase I/II trial determining safety.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has returned or spread and this is confirmed by tests.
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I am 18 years old or older.
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My organ functions are within normal ranges according to recent tests.
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My cancer is advanced, cannot be cured with treatment, and has been confirmed by tests.
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I am fully active or restricted in physically strenuous activity but can do light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have heart problems that affect my daily activities.
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I have no active cancer other than the one being studied.
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I have brain metastases or a primary brain tumor that is causing symptoms or has not been treated.
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I have a severe or active HIV infection.
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I have severe problems controlling my urine or emptying my bladder.
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I haven't needed strong infection medicine in the last 2 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose of study drug through at least 6-8 weeks after end of treatment (up to approximately 2 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study drug through at least 6-8 weeks after end of treatment (up to approximately 2 years)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase 1: Dose-limiting toxicity (DLTs)
Phase 1: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of [177Lu]Lu FAP 2286
Phase 1: recommended Phase 2 dose (RP2D)
+4 moreSecondary study objectives
Phase 1: Absorbed dose (Gy) estimated in organs and tumor lesions
Phase 1: Area under the curve (AUC) of [177Lu]Lu FAP 2286
Phase 1: Clearance (CL) of [177Lu]Lu FAP 2286
+14 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Phase 2: Specific Solid TumorsExperimental Treatment2 Interventions
Up to 192 participants treated with \[177Lu\]Lu-FAP-2286 in tumor-specific participant groups in monotherapy and in combination with chemotherapy.
Group II: Phase 1: Dose EscalationExperimental Treatment2 Interventions
Up to 30 patients with solid tumors.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Peptide-targeted radionuclide therapy, such as [177Lu]Lu FAP 2286, works by targeting specific proteins like fibroblast activation protein (FAP) that are highly expressed on cancer-associated fibroblasts within the tumor microenvironment. This targeted approach allows for the direct delivery of radioactive isotopes to the tumor cells, minimizing damage to surrounding healthy tissues.
For solid tumor patients, this precision in targeting can lead to more effective treatments with fewer side effects, improving overall outcomes and quality of life.
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Who is running the clinical trial?
Clovis Oncology, Inc.Lead Sponsor
64 Previous Clinical Trials
10,809 Total Patients Enrolled
Novartis PharmaceuticalsLead Sponsor
2,916 Previous Clinical Trials
4,253,682 Total Patients Enrolled
Thomas Hope, MDPrincipal InvestigatorUniversity of California, San Francisco
11 Previous Clinical Trials
2,026 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has returned or spread and this is confirmed by tests.I have heart problems that affect my daily activities.I have lost a lot of weight recently.I have mild side effects from cancer treatment.I am of childbearing age and follow the required birth control measures.I have no active cancer other than the one being studied.I have agreed to provide my tumor samples for the study.I am 18 years old or older.I have had radiation therapy within the required time frame.My organ functions are within normal ranges according to recent tests.I haven't had any surgeries unrelated to the study recently.I have brain metastases or a primary brain tumor that is causing symptoms or has not been treated.I have a severe or active HIV infection.I have received cancer treatment recently.I have severe problems controlling my urine or emptying my bladder.My cancer is advanced, cannot be cured with treatment, and has been confirmed by tests.I am fully active or restricted in physically strenuous activity but can do light work.I haven't needed strong infection medicine in the last 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1: Dose Escalation
- Group 2: Phase 2: Specific Solid Tumors
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.