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A Phase 2 Pilot Study to Evaluate the Safety and the Anti-Tumour Activity of the Myc Inhibitor OMO-103 Administered Intravenously in Patients with Advanced High-Grade Osteosarcoma
EU CTIS ID: 2024-510987-22-00
What this study is testing
To assess the preliminary anti-tumour activity of OMO-103 monotherapy in patients with high-grade osteosarcoma
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 2. Age ≥12 years at time of informed consent
- 3. Histologically proven, advanced high-grade osteosarcoma not suitable for local treatments with curative intent
- 4. Confirmed disease progression by radiological report to at least one line of standard chemotherapy containing cisplatin and anthracycline.
- 5. Measurable disease as per RECIST v1.1 criteria and documented by CT/MRI (Appendix 1 – RECIST Response Criteria).
- 6. Provision of a newly obtained tumour biopsy (either from the primary tumour or from metastases) during screening and on-treatment from all patients >16 years of age.
- 7. Documented progression on or following the last line of therapy
You likely can't join if
- 1. Treatment with systemic anti-cancer therapy within three weeks prior to study drug administration for chemotherapy and 5 half-lives for targeted therapies.
- 2. Radiation therapy within four weeks prior to study entry. Localised palliative radiotherapy to non-target lesions is allowed.
- 3. Low-grade osteosarcoma, parosteal, or periosteal osteosarcoma.
- 4. 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.
- 5. Non-malignant systemic disease including cerebrovascular accident, unstable angina pectoris, unstable atrial fibrillation, unstable cardiac arrhythmia, myocardial infarction in the last six months, New York Heart Association (NYHA) Class III or IV heart failure
- 6. Patients with active uncontrolled infection or known to be serologically positive for human immunodeficiency virus (HIV), hepatitis B (except after vaccination) or hepatitis C infection. Investigators may test as per their discretion.
See the full eligibility criteria
Who can join
- 2. Age ≥12 years at time of informed consent
- 3. Histologically proven, advanced high-grade osteosarcoma not suitable for local treatments with curative intent
- 4. Confirmed disease progression by radiological report to at least one line of standard chemotherapy containing cisplatin and anthracycline.
- 5. Measurable disease as per RECIST v1.1 criteria and documented by CT/MRI (Appendix 1 – RECIST Response Criteria).
- 6. Provision of a newly obtained tumour biopsy (either from the primary tumour or from metastases) during screening and on-treatment from all patients >16 years of age.
- 7. Documented progression on or following the last line of therapy
- 12. If not postmenopausal or surgically sterile, female patients and female sexual partners of male patients must be willing to use at least one highly effective method of birth control (hormonal contraception, IUD, abstinence, condom) for at least a menstrual cycle before and for 3 months after last study drug administration.
What rules you out
- 1. Treatment with systemic anti-cancer therapy within three weeks prior to study drug administration for chemotherapy and 5 half-lives for targeted therapies.
- 2. Radiation therapy within four weeks prior to study entry. Localised palliative radiotherapy to non-target lesions is allowed.
- 3. Low-grade osteosarcoma, parosteal, or periosteal osteosarcoma.
- 4. 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.
- 5. Non-malignant systemic disease including cerebrovascular accident, unstable angina pectoris, unstable atrial fibrillation, unstable cardiac arrhythmia, myocardial infarction in the last six months, New York Heart Association (NYHA) Class III or IV heart failure
- 6. Patients with active uncontrolled infection or known to be serologically positive for human immunodeficiency virus (HIV), hepatitis B (except after vaccination) or hepatitis C infection. Investigators may test as per their discretion.
- 7. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.
- 8. Patients with symptomatic or unstable central nervous system primary tumour or metastases and/or sarcomatous meningitis
- Patients with allergies or hypersensitivity reactions to the active substance or to any of its excipients
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.