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LNTH-2403

Phase 1

Relapsed / Refractory Osteosarcoma | Small molecule | Oncology |Lantheus Holdings, Inc.|Trials Updated: May 1, 2026

LNTH-2403 target and mechanism

Molecular targetLRRC15
ModalitySmall molecule

Also known as LNTH2403 Phase 1 dose

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment55

FDA Designations

No designations recorded

LNTH-2403 clinical trials

LNTH-2403 · 1 trial · 1 indication

Phase 1 1
NCT07357519Lu-TARGO (177Lu-TARGeted Osteosarcoma Therapy)Relapsed / Refractory Osteosarcoma
RECRUITING55 Analytics
PHASE1RECRUITING
Lu-TARGO (177Lu-TARGeted Osteosarcoma Therapy)
Relapsed / Refractory OsteosarcomaUnlock trial analytics

Study Endpoints

Primary Endpoints

To identify the maximum tolerated dose (MTD) of LNTH-2403 in participants with R/R osteosarcoma (Ph1)
From enrollment to the end of treatment at 8 weeks

Incidence of DLTs during the first 8 weeks (DLT evaluation window) after the first dose of LNTH-2403

To evaluate the safety and tolerability profile of LNTH-2403 in participants with R/R osteosarcoma (Ph1)
From enrollment to the end of treatment at 8 weeks

Type, frequency, severity, timing, and relationship to LNTH-2403 of all Treatment-emergent adverse event, (TEAEs) and Serious adverse events, (SAEs)

To assess the preliminary anti-neoplastic activity of LNTH-2403 in participants with R/R osteosarcoma (Ph2)
From enrollment to Event-Free Survival (EFS) at 4 months

Event-Free Survival (EFS) at 4 months

Secondary Endpoints

To assess the preliminary anti-neoplastic activity of LNTH-2403 in participants with R/R osteosarcoma (Ph1)
8 weeks
To describe the safety and tolerability profile of LNTH-2403 in participants with R/R osteosarcoma (Ph2)
4 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1- Escalating doses of LNTH-2403 administered once every 8 weeksEXPERIMENTALPhase 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.
Phase 2 will evaluate LNTH-2403 as a single agent at the recommended phase 2 doseEXPERIMENTALPhase 2 will evaluate LNTH-2403 as a single agent in participants with R/R osteosarcoma at the recommended phase 2 dose (RP2D).

Interventions

NameTypeDescription
LNTH2403 Phase 1 doseDRUGLNTH-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.
Phase 2; LNTH2403 a single agent recommended phase 2 dose (RP2D).DRUGOnce the RP2D is selected, phase 2 will commence
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: Participants must meet all the following criteria to be enrolled in the study 1. Histopathologic documented diagnosis of R/R osteosarcoma 2. Must have disease characterized by at least one of the following (Participants meeting only (b.), only (c.), or only (b. and c.) must be d...

Countries:United States
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Frequently asked questions about LNTH-2403

What is LNTH-2403?

LNTH-2403 is an investigational small molecule developed by Lantheus Holdings, Inc. for relapsed or refractory osteosarcoma, a bone cancer that has returned or stopped responding to prior treatment. It is being studied as a single agent and is currently in Phase 1 clinical development.

What is LNTH-2403 used for in relapsed or refractory osteosarcoma?

LNTH-2403 is being evaluated for the treatment of relapsed or refractory osteosarcoma in patients whose disease has returned or progressed after earlier therapy. It is an investigational agent and has not been established as a treatment option outside of clinical research.

What does LNTH-2403 target?

LNTH-2403 targets LRRC15, a protein expressed in the tumor microenvironment. By binding LRRC15, the agent is designed to deliver its therapeutic effect to osteosarcoma tissue. LRRC15 is the molecular target named for this small molecule program.

Who is developing LNTH-2403?

LNTH-2403 is being developed by Lantheus Holdings, Inc., which trades on the Nasdaq under the ticker LNTH. The company is the sponsor of the clinical program evaluating the agent in relapsed or refractory osteosarcoma.

What phase is LNTH-2403 in?

LNTH-2403 is in Phase 1 clinical development. It is an investigational drug and is not approved by the FDA. The Phase 1 program is currently recruiting participants and has not yet completed.

What clinical trials is LNTH-2403 in?

LNTH-2403 is being studied in the Lu-TARGO trial, registered as NCT07357519, titled 177Lu-TARGeted Osteosarcoma Therapy. The Phase 1 trial is recruiting in the United States and plans to enroll 55 participants aged 12 years and older with relapsed or refractory osteosarcoma.

Is LNTH-2403 the same as LNTH2403?

Yes, LNTH-2403 and LNTH2403 refer to the same investigational agent. The alternate spelling appears in references to the Phase 1 dose and the Phase 2 single agent recommended phase 2 dose, or RP2D, of the Lantheus osteosarcoma program.