Lu-TARGO (177Lu-TARGeted Osteosarcoma Therapy)

Conditions

• Relapsed / Refractory Osteosarcoma

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• LNTH2403 Phase 1 dose — DRUG
  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; LNTH2403 a single agent recommended phase 2 dose (RP2D). — DRUG
  Once the RP2D is selected, phase 2 will commence

Study Details

This is a multi-center, non-randomized, open-label, dosimetry and dose-escalation, cohort-expansion study of LNTH-2403 administered to subjects with relapsed / refractory (R/R) osteosarcoma. This study consists of 2 phases: (1) a dosimetry and dose escalation phase; and (2) a cohort expansion phase.

Key Dates

Start date

Feb 3, 2026

Status verified

Jan 2026

Primary completion

Aug 31, 2027

Completion

May 31, 2032

Study Design

Enrollment

55 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

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

Central Contacts

• Kerri Sforzo
  978-671-8886
  [email protected]

Locations (2)

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