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LNTH-2403

Phase 1

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

Target and mechanism

Molecular targetLRRC15
ModalitySmall molecule

Also known as LNTH2403 Phase 1 dose, Phase 2; LNTH2403 a single agent recommended phase 2 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

Clinical trial landscape

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 LNTH2403 Phase 1 dose used for in relapsed/refractory osteosarcoma?

LNTH2403 Phase 1 dose is an investigational small molecule being studied for the treatment of relapsed or refractory osteosarcoma. It is currently in Phase 1 clinical development, with an active trial evaluating its safety and efficacy in patients with this condition.

What does LNTH2403 Phase 1 dose target?

LNTH2403 Phase 1 dose targets LRRC15, a protein involved in tumor biology. By targeting LRRC15, the drug aims to interfere with cancer cell processes, potentially offering a new therapeutic approach for patients with relapsed or refractory osteosarcoma.

Who makes LNTH2403 Phase 1 dose?

LNTH2403 Phase 1 dose is being developed by Lantheus Holdings, Inc., a company traded under the ticker symbol LNTH. The company is conducting clinical research to evaluate this investigational therapy for relapsed or refractory osteosarcoma.

What phase is LNTH2403 Phase 1 dose in?

LNTH2403 Phase 1 dose is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is currently being studied in a clinical trial for patients with relapsed or refractory osteosarcoma.

What clinical trials is LNTH2403 Phase 1 dose in?

LNTH2403 Phase 1 dose is being evaluated in a Phase 1 clinical trial with the identifier NCT07357519, titled Lu-TARGO (177Lu-TARGeted Osteosarcoma Therapy). This trial is recruiting participants in the United States and aims to enroll 55 patients with relapsed or refractory osteosarcoma.

Is LNTH2403 Phase 1 dose the same as Lu-TARGO?

LNTH2403 Phase 1 dose is associated with the clinical trial Lu-TARGO, which stands for 177Lu-TARGeted Osteosarcoma Therapy. The trial NCT07357519 is evaluating this investigational drug in patients with relapsed or refractory osteosarcoma.