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.
Provision of signed and dated informed consent form.
Age ≥12 years at time of informed consent.
Histologically proven, advanced high-grade osteosarcoma not suitable for local treatments with curative intent
Confirmed disease progression by radiological report to at least one line of standard chemotherapy containing cisplatin and anthracycline, and no more than 2 previous lines.
Treatment with systemic anti-cancer therapy within three weeks prior to study drug administration for chemotherapy and 5 half-lives for targeted therapies.
Radiation therapy within four weeks prior to study entry. Localised palliative radiotherapy to nontarget lesions is allowed
Low-grade osteosarcoma, parosteal, or periosteal osteosarcoma.
Prior history of other malignancies other than osteosarcoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of the disease for at least 2 years.
Vall d'Hebron Institute of Oncology
Lead sponsor
Peptomyc S.L.
Collaborator
Osteosarcoma Institute
Collaborator
Curing Kids' Cancer Foundation
Collaborator
Dana-Farber Cancer Institute
Collaborator
Memorial Sloan Kettering Cancer Center
Collaborator
Oregon Health and Science University
Collaborator
The Morgan Adams Foundation
Collaborator
The Kristen Ann Carr Fund
Collaborator