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

Phase 2

Recruiting

• Conditions: Advanced High-Grade Osteosarcoma

• Registration Number: 2024-510987-22-00
• Lead Sponsor: Vall D Hebron Institute Of Oncology

Brief Summary

To assess the preliminary anti-tumour activity of OMO-103 monotherapy in patients with high-grade osteosarcoma

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-09-23
• Last Update Posted: 2024-09-23

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

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).

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.

7. Documented progression on or following the last line of therapy

8. 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 non-target 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

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

Patients with allergies or hypersensitivity reactions to the active substance or to any of its excipients

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival rate at 16 weeks (16-week PFS) according to RECIST V1.1 by Investigator assessment.		Progression-free survival rate at 16 weeks (16-week PFS) according to RECIST V1.1 by Investigator assessment.

Secondary Outcome Measures

Name	Time	Method
• Objective Response Rate (ORR) • Disease Control Rate (DCR) • Time to Progression (TTP) • Time to Response (TTR) • Duration of Response (DOR) • Overall survival (OS)		• Objective Response Rate (ORR) • Disease Control Rate (DCR) • Time to Progression (TTP) • Time to Response (TTR) • Duration of Response (DOR) • Overall survival (OS)
• Incidence and severity of adverse events (AEs), graded by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.• Safety will be assessed through routine monitoring of adverse events, evaluation of laboratory parameters, vital signs, physical examination and ECGs.		• Incidence and severity of adverse events (AEs), graded by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.• Safety will be assessed through routine monitoring of adverse events, evaluation of laboratory parameters, vital signs, physical examination and ECGs.
PK parameters of OMO-103: AUC; Cmax; tmax; t1/2.		PK parameters of OMO-103: AUC; Cmax; tmax; t1/2.
• 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) for adult patients, and by the Pediatric Quality of Life Inventory (PedsQL) for patients between 12 and 17.		• 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) for adult patients, and by the Pediatric Quality of Life Inventory (PedsQL) for patients between 12 and 17.
• Q-TWiST approach [time experiencing toxicity (grade 3/4 AEs) before progression, time without toxicity or symptoms of progression, and time after progression]		• Q-TWiST approach [time experiencing toxicity (grade 3/4 AEs) before progression, time without toxicity or symptoms of progression, and time after progression]

Trial Locations

Locations (1)

Hospital Universitari Vall D Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitari Vall D Hebron

🇪🇸Barcelona, Spain

Claudia Valverde

Site contact

+34932746085

cvalverde@vhio.net