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.
Single group
OMO-103
DrugOMO-103 administered at the recommended phase 2 dose (6.5 mg/kg as a weekly intravenous infusion in 28-day cycles).
Preliminary anti-tumour activity of OMO-103 monotherapy in patients with high-grade osteosarcoma
Progression-free survival rate at 16 weeks (16-week PFS)
Further evaluate the anti-tumour activity of OMO-103 monotherapy in patients with high-grade osteosarcoma.
• Objective Response Rate (ORR) is defined as the percentage of patients with a complete response (CR) or a partial response (PR) by Investigator according to RECIST 1.1 in solid tumours.
Further evaluate the anti-tumour activity of OMO-103 monotherapy in patients with high-grade osteosarcoma.
• Disease Control Rate (DCR) is defined as the percentage of patients in whom the best overall response is determined as CR, PR, or stable disease (SD) by the Investigator according to RECIST 1.1 in solid tumours.
Further evaluate the anti-tumour activity of OMO-103 monotherapy in patients with high-grade osteosarcoma.
• Time to Response (TTR) is defined as the time from start of treatment to the date of first documentation of CR, or PR.
Further evaluate the anti-tumour activity of OMO-103 monotherapy in patients with high-grade osteosarcoma.
• Time to Progression (TTP) is defined as the time from start of treatment to the date of first documentation of disease progression.
Click on the lead sponsor to view all of their trials.
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
