RecruitingPhase 1Phase 2NCT05588648

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

A Phase I/II, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Vactosertib as a Single Agent in Adolescents and Adults With Recurrent, Refractory or Progressive Osteosarcoma

Sponsor

MedPacto, Inc.

Enrollment

48 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

Osteosarcoma

Summary

MP-VAC-209 is a Phase I/II, open label, single arm, multi-center study to assess safety, tolerability, and antitumor activity of vactosertib as a single agent in adolescents and adults with recurrent, refractory, or progressive osteosarcoma. Vactosertib is given orally, twice a day, to people 12 years of age and older who meet the criteria for study enrollment.

Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called vactosertib in teenagers and adults with osteosarcoma (a type of bone cancer) that has come back or stopped responding to treatment. The drug works by blocking a signaling pathway that helps cancer cells grow. **You may be eligible if...** - You are 12 years of age or older - You have osteosarcoma that has recurred, is not responding to treatment, or is getting worse - You are male or female **You may NOT be eligible if...** - You have moderate or severe heart disease - You have uncontrolled infections, uncontrolled high blood pressure, or severe heart failure - You have other serious health conditions that would make it unsafe to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVactosertib

Vactosertib is given twice a day, five days on and two days off in four-week cycles. Vactosertib is a transforming growth factor-beta (TGF-β) type 1 receptor inhibitor.