Vactosertib for Recurrent, Refractory, or Progressive Osteosarcoma

This study is testing a drug called vactosertib in adolescents and adults with osteosarcoma (a type of bone cancer) that has returned, is resistant to treatment, or has gotten worse. Vactosertib is given by mouth twice a day, five days on and two days off, in four-week cycles. It works by blocking a protein called TGF-beta type 1 receptor, which can help stop cancer growth. Researchers want to see how safe vactosertib is and if it can shrink tumors. The study plans to enroll 48 participants aged 12 and older. The main goal is to find the safest and most effective dose of vactosertib.

Study design
This is a Phase I/II, open-label (meaning you and your doctors will know what treatment you are receiving), single-arm study, meaning all participants will receive vactosertib. It aims to enroll 48 participants.
What's involved
You would take vactosertib twice a day, five days on and two days off, in four-week cycles. Your safety will be monitored through adverse event assessments and laboratory tests throughout the study, which is expected to last about one year.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be assessed through adverse events and laboratory abnormalities until the end of the study, which is an average of one year.

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NCT05588648

Study to Assess Safety and Efficacy of Vactosertib in Adolescents and Adults With Recurrent, Refractory or Progressive Osteosarcoma

Recruiting
PHASE1Ages 12+InterventionalTreatment
MedPacto, Inc.
~48 participants
Updated 2025-04-10 on ClinicalTrials.gov
What's tested:Vactosertib

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose finding associated with the overall nature and severity of AEs associated with treatment.
Measured over Assessment of adverse events and laboratory abnormalities. through study completion, an average of 1 year
Osteosarcoma
3 sites across 2 states
South Korea2
Ohio1

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  • Dose finding associated with the overall nature and severity of AEs associated with treatment.Assessment of adverse events and laboratory abnormalities. through study completion, an average of 1 year

    Maximum tolerated dose (MTD) and recommended dose (RD)