What side effects are associated with this type of intervention?

Peptide-targeted radionuclide therapies, such as [177Lu]Lu FAP 2286, commonly cause hematologic side effects including anemia, thrombocytopenia, and neutropenia. Non-hematologic side effects can include fatigue, nausea, and localized pain. Organ-specific toxicities, such as liver or kidney dysfunction, may also occur depending on the targeted area. These therapies generally result in less systemic toxicity compared to traditional chemotherapy due to their targeted approach.

What prior FDA approvals exist?

The FDA has previously approved several treatments for solid tumors that involve radionuclide therapy. One notable example is Lutetium Lu 177 dotatate (Lutathera), which is a peptide receptor radionuclide therapy (PRRT) used for treating gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This therapy targets somatostatin receptors on tumor cells, similar to how [177Lu]Lu FAP 2286 targets FAP-expressing cells. Another example is Radium-223 dichloride (Xofigo), approved for the treatment of bone metastases in castration-resistant prostate cancer. These therapies highlight the potential of radionuclide treatments in targeting specific tumor markers, akin to the mechanism of [177Lu]Lu FAP 2286.

What other types of research exist?

Promising novel alternatives to [177Lu]Lu FAP 2286 for solid tumor patients include: 1) Immune checkpoint inhibitors such as pembrolizumab and nivolumab, which target PD-1/PD-L1 pathways. 2) CAR-T cell therapies targeting specific tumor antigens. 3) Other peptide-targeted radionuclide therapies like [225Ac]Ac-PSMA-617 for prostate cancer. 4) Multitargeted kinase inhibitors such as regorafenib and lenvatinib. 5) Novel combinations of existing therapies, such as combining immunotherapy with chemotherapy or targeted therapy.

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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 below

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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:

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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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug through at least 6-8 weeks after end of treatment (up to approximately 2 years) for reporting.

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 more

Secondary 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 more

Awards & 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.

0 / 11Eligibility criteria met

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.