Condition: Osteosarcoma · Osteosarcoma in Children · Sponsor: Vall d'Hebron Institute of Oncology
This is an open-label, unicentric, single-arm Phase 2 pilot study to serve as a proof-of-concept of OMO-103 safety and activity in patients with advanced high-grade osteosarcoma. Patients will be treated at the RP2D (6.5 mg/kg as a weekly IV infusion) of OMO-103 to estimate anti-tumour activity and further characterise the safety, tolerability, PK, and PD of OMO-103 in advanced high-grade osteosarcoma patients. Ten (10) evaluable patients will be enrolled. At least 30% of patients will be \<18 years old. The first three patients 12-15 years of age will undergo additional safety monitoring. Patients will be treated until progression by RECIST v1.1 or intolerable toxicity.
This description comes directly from the study's public registry record.
Claudia M Valverde · +34932746085 · cvalverde@vhio.net
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| Hospital Universitari Vall d'Hebron | Barcelona, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06650514