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Trial 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
NCT ID:
NCT06650514
Condition:
Osteosarcoma
Osteosarcoma in Children
Conditions: Official terms:
Osteosarcoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
OMO-103
Description:
OMO-103 administered at the recommended phase 2 dose (6.5 mg/kg as a weekly intravenous
infusion in 28-day cycles).
Arm group label:
OMO-103
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Provision of signed and dated informed consent form.
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, and no more than 2
previous lines.
5. 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:
1. not reside in a field that has been subjected to prior radiotherapy, or
2. have demonstrated clear evidence of radiographic progression since the
completion of prior radiotherapy and prior to study enrolment.
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.
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).
7. Documented progression on or following the last line of therapy.
8. ECOG performance status 0-2 (Appendix 2 - Performance Status Criteria).
9. Life expectancy of ≥ 12 weeks as estimated by the treating physician.
10. Resolution of all acute, reversible toxic effects of prior therapy or surgical
procedure to Grade ≤1 (except alopecia and peripheral neuropathy to Grade ≤2).
11. Adequate organ function.
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.
Exclusion Criteria:
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 nontarget 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 (Appendix 5 - New York Heart Association Criteria).
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
9. Live vaccine in the last four weeks.
10. Current participation in another interventional therapeutic trial.
11. Is pregnant or breastfeeding or expecting to conceive or father children within the
projected duration of the study.
12. Knowledge of any other disease or medication that may interfere with study
treatment.
13. Patients with known allergies or hypersensitivity reactions to the active substance
or to any of its excipients
14. Patient unable to comply with the study protocol owing to psychological, social
(lack of social support or social exclusion) or geographical reasons.
Gender:
All
Minimum age:
12 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 2024
Completion date:
December 2026
Lead sponsor:
Agency:
Vall d'Hebron Institute of Oncology
Agency class:
Other
Collaborator:
Agency:
Peptomyc S.L.
Agency class:
Industry
Collaborator:
Agency:
Osteosarcoma Institute
Agency class:
Other
Collaborator:
Agency:
Curing Kids' Cancer Foundation
Agency class:
Other
Collaborator:
Agency:
Dana-Farber Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Collaborator:
Agency:
Oregon Health and Science University
Agency class:
Other
Source:
Vall d'Hebron Institute of Oncology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06650514
