OsteosarcomaPhase 2OsteomycNCT06650514
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
A Phase 2 study testing OMO-103 in people with Osteosarcoma and Osteosarcoma in Children, run by Vall d'Hebron Institute of Oncology at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Osteosarcoma, Osteosarcoma in Children
- What is being tested?
- OMO-103
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 27 Dec 2024to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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 tumour lesions that can be accessible for biopsy with acceptable clinical risk in the judgement of the Investigator.
- 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, abstinence, condom) for at least a menstrual cycle before and for 3 months after last study drug administration.
Who cannot join
- 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.
- 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 (Appendix 5 - New York Heart Association Criteria).
- 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.
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- 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.
- 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 interventional 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Claudia Valverde, MD, +34932746085, cvalverde@vhio.net
About this study
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.
- Conditions
- Osteosarcoma, Osteosarcoma in Children
- Being tested
- OMO-103
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMO-103Drug
OMO-103 administered at the recommended phase 2 dose (6.5 mg/kg as a weekly intravenous infusion in 28-day cycles).
| Study group | Role | What they receive |
|---|---|---|
| OMO-103 | Experimental | OMO-103 administered at the recommended phase 2 dose (6.5 mg/kg as a weekly intravenous infusion in 28-day cycles) Receives: Drug: OMO-103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preliminary anti-tumour activity of OMO-103 monotherapy in patients with high-grade osteosarcoma
Progression-free survival rate at 16 weeks (16-week PFS)
Measured: 16 weeks from start of treatment
Secondary outcomes (14)
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.
Measured: Until disease progression, unacceptable toxicity, patient request, physician's decision to withdraw treatment, subsequent anticancer therapy, or death whichever occurs first, assessed up to 24 months
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.
Measured: Until disease progression, unacceptable toxicity, patient request, physician's decision to withdraw treatment, subsequent anticancer therapy, or death whichever occurs first, assessed up to 24 months
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.
Measured: Until disease progression, unacceptable toxicity, patient request, physician's decision to withdraw treatment, subsequent anticancer therapy, or death whichever occurs first, assessed up to 24 months
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.
Measured: Until disease progression, unacceptable toxicity, patient request, physician's decision to withdraw treatment, subsequent anticancer therapy, or death whichever occurs first, assessed up to 24 months
Further evaluate the anti-tumour activity of OMO-103 monotherapy in patients with high-grade osteosarcoma.
- Duration of Response (DOR) refers to the minimum from the time when complete response (CR) or partial response (PR) is first observed to the time of progressed disease (PD)
Measured: Until disease progression, unacceptable toxicity, patient request, physician's decision to withdraw treatment, subsequent anticancer therapy, or death whichever occurs first, assessed up to 24 months
Further evaluate the anti-tumour activity of OMO-103 monotherapy in patients with high-grade osteosarcoma.
- Overall survival (OS) is defined as the time from the date of start of treatment to the date of death due to any cause. Patients without documentation of death at the time of analysis will be censored at the date last known to be alive.
Measured: Until patient request or death whichever occurs first, assessed up to 24 months
Safety and tolerability profile of OMO-103 monotherapy in patients with high-grade osteosarcoma.
Incidence and severity of adverse events (AEs), graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.
Measured: Unrtil end of treatment assessed up to 24 months
Assess the benefit/risk ratio associated with OMO-103
Q-TWiST approach (Quality-adjusted Time Without Symptoms of disease recurrence or Toxicity of treatment)time experiencing toxicity (grade 3/4 AEs) before progression, time without toxicity or symptoms of progression, and time after progression
Measured: Until progression assessed up to 24 months
To characterise the pharmacokinetics (PK) of OMO-103 monotherapy in patients with high-grade osteosarcoma (12-15 years of age).
PK parameters of OMO-103: AUC (Area Under the Curve)
Measured: During the first cycle of treatment (4 weeks)
To characterise the pharmacokinetics (PK) of OMO-103 monotherapy in patients with high-grade osteosarcoma (12-15 years of age).
PK parameters of OMO-103: Cmax (Peak Plasma Concentration)
Measured: During the first cycle of treatment (4 weeks)
To characterise the pharmacokinetics (PK) of OMO-103 monotherapy in patients with high-grade osteosarcoma (12-15 years of age).
PK parameters of OMO-103: tmax (time to peak drug concentration)
Measured: During the first cycle of treatment (4 weeks)
To characterise the pharmacokinetics (PK) of OMO-103 monotherapy in patients with high-grade osteosarcoma (12-15 years of age).
PK parameters of OMO-103: t1/2 (elimination half life)
Measured: During the first cycle of treatment (4 weeks)
Evaluate quality of life (QoL) in patients with high-grade osteosarcoma
For adult patients: Health-related quality of life (HRQoL) measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items (EORTC-C30)
Measured: Unitl end of treatment assessed up to 24 months
Evaluate quality of life (QoL) in patients with high-grade osteosarcoma
For patients between 12 and 17 years of old Health-related quality of life (HRQoL) measured by the Pediatric Quality of Life Inventory (PedsQL)
Measured: Unitl end of treatment assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start27 Dec 2024
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vall d'Hebron Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Peptomyc S.L., Osteosarcoma Institute, Curing Kids' Cancer Foundation, Dana-Farber Cancer Institute, Memorial Sloan Kettering Cancer Center, Oregon Health and Science University, The Morgan Adams Foundation, The Kristen Ann Carr Fund
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650514
- Sponsor's protocol ID
- VHIO23003
- Other IDs
- 2024-510987-22-00
- Acronym
- Osteomyc
- Status last verified
- Nov 2024
- First submitted
- 14 Oct 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- Osteomyc / VHIO23003
- Conditions
- Osteosarcoma, Osteosarcoma in Children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Vall d'Hebron Institute of OncologyUniversity, hospital or other
- Collaborators
- Peptomyc S.L., Osteosarcoma Institute, Curing Kids' Cancer Foundation, Dana-Farber Cancer Institute, Memorial Sloan Kettering Cancer Center, Oregon Health and Science University, The Morgan Adams Foundation, The Kristen Ann Carr Fund
- Study start
- 27 Dec 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OMO-103 | Experimental | Drug: OMO-103OMO-103 administered at the recommended phase 2 dose (6.5 mg/kg as a weekly intravenous infusion in 28-day cycles) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
Key exclusion criteria (14 listed)
- 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.
- 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 (Appendix 5 - New York Heart Association Criteria).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMO-103OMO-103 administered at the recommended phase 2 dose (6.5 mg/kg as a weekly intravenous infusion in 28-day cycles). | Drug | OMO-103 |
Primary outcome
Preliminary anti-tumour activity of OMO-103 monotherapy in patients with high-grade osteosarcoma
Time frame: 16 weeks from start of treatment
Progression-free survival rate at 16 weeks (16-week PFS)
14 secondary outcomes
Further evaluate the anti-tumour activity of OMO-103 monotherapy in patients with high-grade osteosarcoma.
Time frame: Until disease progression, unacceptable toxicity, patient request, physician's decision to withdraw treatment, subsequent anticancer therapy, or death whichever occurs first, assessed up to 24 months
Further evaluate the anti-tumour activity of OMO-103 monotherapy in patients with high-grade osteosarcoma.
Time frame: Until disease progression, unacceptable toxicity, patient request, physician's decision to withdraw treatment, subsequent anticancer therapy, or death whichever occurs first, assessed up to 24 months
Further evaluate the anti-tumour activity of OMO-103 monotherapy in patients with high-grade osteosarcoma.
Time frame: Until disease progression, unacceptable toxicity, patient request, physician's decision to withdraw treatment, subsequent anticancer therapy, or death whichever occurs first, assessed up to 24 months
Further evaluate the anti-tumour activity of OMO-103 monotherapy in patients with high-grade osteosarcoma.
Time frame: Until disease progression, unacceptable toxicity, patient request, physician's decision to withdraw treatment, subsequent anticancer therapy, or death whichever occurs first, assessed up to 24 months
Further evaluate the anti-tumour activity of OMO-103 monotherapy in patients with high-grade osteosarcoma.
Time frame: Until disease progression, unacceptable toxicity, patient request, physician's decision to withdraw treatment, subsequent anticancer therapy, or death whichever occurs first, assessed up to 24 months
Further evaluate the anti-tumour activity of OMO-103 monotherapy in patients with high-grade osteosarcoma.
Time frame: Until patient request or death whichever occurs first, assessed up to 24 months
Safety and tolerability profile of OMO-103 monotherapy in patients with high-grade osteosarcoma.
Time frame: Unrtil end of treatment assessed up to 24 months
Assess the benefit/risk ratio associated with OMO-103
Time frame: Until progression assessed up to 24 months
To characterise the pharmacokinetics (PK) of OMO-103 monotherapy in patients with high-grade osteosarcoma (12-15 years of age).
Time frame: During the first cycle of treatment (4 weeks)
To characterise the pharmacokinetics (PK) of OMO-103 monotherapy in patients with high-grade osteosarcoma (12-15 years of age).
Time frame: During the first cycle of treatment (4 weeks)
To characterise the pharmacokinetics (PK) of OMO-103 monotherapy in patients with high-grade osteosarcoma (12-15 years of age).
Time frame: During the first cycle of treatment (4 weeks)
To characterise the pharmacokinetics (PK) of OMO-103 monotherapy in patients with high-grade osteosarcoma (12-15 years of age).
Time frame: During the first cycle of treatment (4 weeks)
Evaluate quality of life (QoL) in patients with high-grade osteosarcoma
Time frame: Unitl end of treatment assessed up to 24 months
Evaluate quality of life (QoL) in patients with high-grade osteosarcoma
Time frame: Unitl end of treatment assessed up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OMO-103 in people with Osteosarcoma and Osteosarcoma in Children, run by Vall d'Hebron Institute of Oncology at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudia M Valverde (+34932746085, cvalverde@vhio.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preliminary anti-tumour activity of OMO-103 monotherapy in patients with high-grade osteosarcoma (time frame: 16 weeks from start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.