Actively Recruiting
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
Led by Vall d'Hebron Institute of Oncology · Updated on 2025-01-10
10
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
Sponsors
V
Vall d'Hebron Institute of Oncology
Lead Sponsor
P
Peptomyc S.L.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form provided
- Age 12 years or older at consent
- Histologically confirmed advanced high-grade osteosarcoma not suitable for curative local treatments
- Disease progression confirmed after at least one standard chemotherapy line including cisplatin and anthracycline, with no more than two previous lines
- Measurable disease by RECIST v1.1 documented by CT/MRI; lesions must be non-irradiated or show progression after radiotherapy
- Newly obtained tumor biopsy during screening and on-treatment for patients older than 16 years, unless recent biopsy available and no treatment since
- Documented progression on or after last therapy line
- ECOG performance status 0-2
- Life expectancy of at least 12 weeks
- Resolution of prior therapy toxic effects to Grade 1 or less (except alopecia and peripheral neuropathy up to Grade 2)
- Adequate organ function
- Female patients or female partners of male patients not postmenopausal or surgically sterile must use effective birth control from one menstrual cycle before to three months after last study drug
You will not qualify if you...
- Systemic anti-cancer therapy within 3 weeks prior to study drug (chemotherapy) or 5 half-lives (targeted therapies)
- Radiation therapy within 4 weeks prior to study, except localized palliative radiotherapy to non-target lesions
- Low-grade, parosteal, or periosteal osteosarcoma
- Prior other malignancies except certain skin or cervical cancers unless disease-free for at least 2 years
- Non-malignant systemic diseases including recent myocardial infarction, unstable cardiac conditions, or NYHA Class III/IV heart failure
- Active uncontrolled infection or positive for HIV, hepatitis B (except post-vaccination), or hepatitis C
- Severe acute or chronic medical/psychiatric conditions or lab abnormalities increasing risk or interfering with study
- Symptomatic or unstable CNS tumor, metastases, or sarcomatous meningitis
- Live vaccine within 4 weeks
- Current participation in another interventional therapeutic trial
- Pregnant, breastfeeding, or planning pregnancy during study
- Conditions or medications that may interfere with study treatment
- Known allergies to OMO-103 or its components
- Inability to comply with study protocol due to psychological, social, or geographic reasons
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Trial Site Locations
Total: 1 location
1
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
Research Team
C
Claudia M Valverde
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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