OncoMatch/Clinical Trials/NCT05588648
Study to Assess Safety and Efficacy of Vactosertib in Adolescents and Adults With Recurrent, Refractory or Progressive Osteosarcoma
Official title: 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
Is NCT05588648 recruiting? Yes, currently enrolling (Oct 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
Cannot have received: TGF-β pathway inhibitor
Subjects who have received prior treatment targeting the signaling pathway of TGF-β
Lab requirements
Blood counts
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 (criteria not fully specified in excerpt)
Liver function
Total bilirubin ≤ 1.5x ULN for age; AST (SGOT) and ALT (SGPT) ≤ 2.5x ULN; Albumin > 2 g/dL
Cardiac function
Ejection fraction ≥ 50% by echocardiogram or MUGA
Adequate bone marrow function defined as: i. Peripheral absolute neutrophil count (ANC) ≥ 750/mcL ii. Platelet count ≥ 75,000/mcL (transfusion independent) iii. Hemoglobin ≥ 8.0 g/dL (may receive packed red blood cell transfusions) b. Adequate liver function defined as: i. Total bilirubin ≤ 1.5 times the upper limit of normal for age ii. AST (SGOT) and ALT (SGPT) 2.5 X institutional upper limit of normal iii. Albumin (serum or plasma) > 2 g/dL c. Adequate cardiac function defined as: i. Ejection fraction of ≥ 50% by echocardiogram or MUGA
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 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