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Tests treatment safety and results for Osteosarcoma
Official title 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
ClinicalTrials.gov ID: NCT06650514
What this study is testing
What is OMO-103?
OMO-103 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for osteosarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- 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...
- Measurable disease as per RECIST v1.1 criteria and documented by CT/MRI (Appendix 1 - RECIST Response Criteria). NOTE: Lesions to be used as...
You likely can't join if
- Treatment with systemic anti-cancer therapy within three weeks prior to study drug administration for chemotherapy and 5 half-lives for targeted...
- 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...
- Non-malignant systemic disease including cerebrovascular accident, unstable angina pectoris, unstable atrial fibrillation, unstable cardiac...
- Patients with active uncontrolled infection or known to be serologically positive for human immunodeficiency virus (HIV), hepatitis B (except after...
See the full eligibility criteria
- 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.
- Measurable disease as per RECIST v1.1 criteria and documented by CT/MRI (Appendix 1 - RECIST Response Criteria). NOTE: Lesions to be used as measurable disease for the purpose of response assessment must either:
- not reside in a field that has been subjected to prior radiotherapy, or
- have demonstrated clear evidence of radiographic progression since the completion of prior radiotherapy and prior to study enrolment.
- 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. Notes:
- The identified lesion to be biopsied should not have been previously irradiated and should not be the only lesion being used as a measurable-disease target lesion for objective response assessment. Patients must have...
- In case a patient has had a tumour biopsy in the previous 6 months and a paraffin block is available, a new biopsy does not need to be done at Screening (if they have received no treatment after biopsy).
- Documented progression on or following the last line of therapy.
- ECOG performance status 0-2 (Appendix 2 - Performance Status Criteria).
- Life expectancy of ≥ 12 weeks as estimated by the treating physician.
- Resolution of all acute, reversible toxic effects of prior therapy or surgical procedure to Grade ≤1 (except alopecia and peripheral neuropathy to Grade ≤2).
- Adequate organ function.
- 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...
- 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...
- 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...
- 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...
- 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...
- Patients with symptomatic or unstable central nervous system primary tumour or metastases and/or sarcomatous meningitis
- Live vaccine in the last four weeks.
- Current participation in another treatment therapeutic trial.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study.
- Knowledge of any other disease or medication that may interfere with study treatment.
- Patients with known allergies or hypersensitivity reactions to the active substance or to any of its excipients
- Patient unable to comply with the study protocol owing to psychological, social (lack of social support or social exclusion) or geographical reasons.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Spain
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, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.