OncoMatch/Clinical Trials/NCT05588648
Study to Assess Safety and Efficacy of Vactosertib in Adolescents and Adults With Recurrent, Refractory or Progressive Osteosarcoma
Is NCT05588648 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies Vactosertib for osteosarcoma.
Treatment: Vactosertib — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Osteosarcoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: conventional therapy
have progressed, relapsed or become refractory to conventional therapy
Cannot have received: TGF-β pathway inhibitor
Subjects who have received prior treatment targeting the signaling pathway of TGF-β
Cannot have received: other investigational products
Exception: washout period of 28 days or 5 half-lives
Subjects who were treated with other investigational products within 28 days before screening or within a period shorter than 5-times the half-life of the investigational product
Lab requirements
Blood counts
Peripheral absolute neutrophil count (ANC) ≥ 750/mcL; Platelet count ≥ 75,000/mcL (transfusion independent); Hemoglobin ≥ 8.0 g/dL (may receive packed red blood cell transfusions)
Kidney function
adequate renal function; see laboratory inclusion
Liver function
Total bilirubin ≤ 1.5 times the upper limit of normal for age; AST (SGOT) and ALT (SGPT) 2.5 X institutional upper limit of normal; Albumin (serum or plasma) > 2 g/dL
Cardiac function
Ejection fraction of ≥ 50% by echocardiogram or MUGA
Subjects must have normal organ and marrow function as defined below: ... Adequate bone marrow function ... Adequate liver function ... Adequate cardiac function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UH Rainbow Babies & Children's Hospital · Cleveland, Ohio
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05588648 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior TGF-β pathway inhibitor, other investigational products disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages