Actively Recruiting
A Phase 2 Pilot Study to Evaluate the Safety and Anti-Tumor 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
26 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
Researchers are evaluating the safety and anti-tumor activity of OMO-103, a Myc inhibitor, in patients with advanced high-grade osteosarcoma. This phase 2 pilot study aims to provide proof-of-concept data on the drug's effects and tolerability. The study includes patients aged 12 years and older with disease progression after standard chemotherapy. Participants receive OMO-103 intravenously at a dose of 6.5 mg/kg once weekly in 28-day cycles. Treatment continues until the cancer progresses or intolerable side effects occur. Additional safety monitoring will be conducted for patients aged 12 to 15 years. The study plans to enroll ten evaluable patients, with at least 30% under 18 years of age. During the study, patients undergo tumor biopsies, imaging scans, and assessments to measure tumor response and drug pharmacokinetics. Quality of life and safety are monitored throughout treatment, with evaluations continuing up to 24 months or until withdrawal. The primary outcome is the anti-tumor activity after 16 weeks of treatment, with ongoing follow-up for safety, tolerability, and treatment effects.
CONDITIONS
Brief 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 informed consent form
- Age 12 years or older at time of consent
- Histologically confirmed advanced high-grade osteosarcoma not suitable for curative local treatments
- Disease progression after at least one standard chemotherapy including cisplatin and anthracycline, with no more than two prior lines
- Measurable disease by RECIST v1.1 confirmed by CT or MRI
- Newly obtained tumor biopsy during screening and on-treatment for patients over 16 years old
- Documented progression on or after last therapy line
- ECOG performance status 0-2
- Life expectancy of 12 weeks or more
- Resolution of acute toxic effects of prior therapy to Grade 1 or less (except alopecia and certain neuropathy)
- Adequate organ function
- Use of effective birth control for females and female partners if not postmenopausal or sterile
You will not qualify if you...
- Systemic anti-cancer therapy within 3 weeks for chemotherapy or 5 half-lives for targeted therapies before study drug
- Radiation therapy within 4 weeks prior to study entry (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 2 years
- Non-malignant systemic diseases including recent severe cardiac conditions
- Active uncontrolled infections or known HIV, hepatitis B or C infection
- Severe acute or chronic medical or psychiatric conditions increasing risk or interfering with results
- Symptomatic or unstable central nervous system tumors or metastases
- Live vaccine within 4 weeks
- Current participation in another interventional therapeutic trial
- Pregnant, breastfeeding, or planning pregnancy during study
- Known allergies to study drug or its components
- Inability to comply with study protocol due to psychological, social, or geographical reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months or until treatment discontinuation
Participants receive OMO-103 as a weekly intravenous infusion in 28-day cycles until disease progression, unacceptable toxicity, patient request, physician's decision to withdraw treatment, subsequent anticancer therapy, or death.
Weekly visits for infusion every 28-day cycle
Trial Site Locations
Total: 1 location
1
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
Research Team
C
Claudia M Valverde
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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