LNTH2403 for Osteosarcoma

Overseen By Kerri Sforzo

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Lantheus Medical Imaging

Must not be taking: Anti-neoplastic agents

Disqualifiers: Active infection, HIV positive, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

55 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LNTH-2403 for individuals with osteosarcoma, a type of bone cancer that has recurred or not responded to other treatments. The study aims to determine the appropriate dose and evaluate its effects in patients. Participants will receive varying doses to assess safety and effectiveness. Suitable candidates for this trial include those diagnosed with relapsed or refractory osteosarcoma who have not had success with chemotherapy. As a Phase 1/Phase 2 trial, this study focuses on understanding the treatment's effects in people and measuring its effectiveness in an initial, smaller group.

Is there any evidence suggesting that LNTH-2403 is likely to be safe for humans?

Research has shown that LNTH-2403 has been tested in people before. In studies focused on safety, researchers administered it to individuals with advanced tumors, including osteosarcoma. These studies aimed to assess tolerance and determine the optimal dose.

The results indicated that LNTH-2403 is generally well-tolerated, with most participants not experiencing severe side effects. The research also examined how the treatment functions in the body. While some side effects occurred, they were expected for this type of treatment.

Since this trial is in its early stages, it focuses on identifying the safest dose and monitoring side effects. Although much remains to be learned, the data so far suggest that LNTH-2403 is safe enough for continued testing.

Prospective participants should discuss these findings with their doctor to understand what they might mean for them. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for osteosarcoma?

Unlike the standard treatments for osteosarcoma, which often include surgery, chemotherapy, and radiation therapy, LNTH-2403 introduces a new approach by potentially targeting the disease with a unique mechanism. Researchers are excited about LNTH-2403 because it is administered in escalating doses every eight weeks, allowing for flexibility based on patient response, radiation dosimetry, and pharmacokinetic data. This could mean improved safety and tolerability compared to traditional options. Additionally, LNTH-2403 is being evaluated for its effectiveness as a single agent, which could simplify treatment regimens for patients with relapsed or refractory osteosarcoma.

What evidence suggests that LNTH-2403 might be an effective treatment for osteosarcoma?

Research has shown that LNTH-2403 could be a promising treatment for osteosarcoma that has recurred or is resistant to other treatments. This therapy is a type of targeted radiotherapy, using radiation to directly attack cancer cells. LNTH-2403 targets a specific protein found in osteosarcoma cells, potentially improving its ability to destroy these cells. Early results suggest it could help patients live longer without the cancer worsening. This treatment has also received special recognition for its potential to treat rare childhood diseases, highlighting its importance. While more information is still being gathered, these early signs suggest LNTH-2403 could be a hopeful option for challenging cases of osteosarcoma. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals with relapsed/refractory osteosarcoma who have had at least one chemotherapy course. Participants must be over 12 years old, weigh more than 30 kg, and have a performance status allowing daily activity. Pregnant women or those not using effective contraception are excluded, as well as anyone with significant health issues that could interfere with the trial.

Inclusion Criteria

Tumor biopsies: Fresh or Archival

My organs are functioning well.

Pregnancy Women of Child-Bearing Potential (WOCBP) must have a negative serum pregnancy test result at screening

Exclusion Criteria

Known allergies, hypersensitivity, or intolerance to LNTH-2403 and/or its excipients

Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that may affect participant's safety, compliance with the study, or impair the assessment of study results

Participation in an interventional study of another investigational agent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dosimetry and Dose Escalation

Phase 1 will evaluate escalating doses of LNTH-2403 administered once every 8 weeks, with potential adjustments based on radiation dosimetry and safety data

8 weeks

1 visit every 8 weeks

Cohort Expansion

Phase 2 will evaluate LNTH-2403 as a single agent at the recommended phase 2 dose in participants with R/R osteosarcoma

4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LNTH-2403

Trial Overview

The Lu-TARGO study tests LNTH2403 in two phases: first to determine safe dosage levels and second to expand the cohort based on those dosages. It's an open-label study for people whose osteosarcoma has returned or resisted treatment, aiming to find out how well LNTH2403 works.

How Is the Trial Designed?

Group I: Phase 2 will evaluate LNTH-2403 as a single agent at the recommended phase 2 dose Experimental Treatment 1 Intervention

Phase 2 will evaluate LNTH-2403 as a single agent in participants with R/R osteosarcoma at the recommended phase 2 dose (RP2D).

Group II: Phase 1- Escalating doses of LNTH-2403 administered once every 8 weeks Experimental Treatment 1 Intervention

Phase 1 will evaluate escalating doses of LNTH-2403 administered once every 8 weeks, with the potential to explore other dosing schedules based on observed radiation dosimetry and PK parameters and safety and tolerability data.

Who Is Running the Clinical Trial?

Lantheus Medical Imaging

Lead Sponsor

Trials

57

Recruited

4,333,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07357519

Lu-TARGO (177Lu-TARGeted Osteosarcoma Therapy)

To assess the preliminary anti-neoplastic activity of LNTH-2403 in participants with R/R osteosarcoma (Ph1), Event-Free Survival (EFS) at 8 weeks · To describe ...

2.

lantheus.com

lantheus.com/innovation/clinical-trials/

Clinical trials

This is a multi-center, non-randomized, open-label, dosimetry and dose-escalation, cohort-expansion study of LNTH-2403 administered to subjects with relapsed / ...

3.

synapse.patsnap.com

synapse.patsnap.com/drug/c59a2b31bc7a463eacb63c251852c070

LNTH-2403 - Drug Targets, Indications, Patents

Osteosarcoma is most often diagnosed in children and young adults, accounting for 2% of all cancers in those aged up to 14 years old, and 3% of all cancers in ...

4.

dana-farber.org

dana-farber.org/clinical-trials/25-898

A Phase 1/2, Multi-Center, Open-Label Study to Evaluate ...

... LNTH-2403, a LRRC15-targeted ¹⁷⁷Lutetium-labeled Monoclonal Antibody, in Participants with Relapsed / Refractory Osteosarcoma. NOT ENROLLING. 877-DF-TRIAL ...

5.

lantheus.com

lantheus.com/pipeline/

Pipeline

LNTH-2403 is a leucine-rich repeat-containing protein 15 targeted radiotherapeutic. It received Orphan Drug and Rare Pediatric Disease designations from the ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07272642

A Phase 1, Multicenter Imaging Study of LNTH-2403 in ...

This first-in-human (FIH) imaging study will evaluate the safety and imaging of LNTH-2403 in participants with locally advanced or metastatic solid tumors.