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Study on the Safety and Tumor-Fighting Effects of OMO-103 for Patients with Advanced Osteosarcoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Advanced High-Grade Osteosarcoma, which is a severe form of bone cancer. The treatment being tested in this study is a medication known as Omomyc, with the code name OMO-103. This medication is given to patients through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. The purpose of the study is to evaluate the safety and effectiveness of Omomyc in treating this type of cancer.

Participants in the study will receive the medication over a period of time, and their health will be monitored closely to see how the cancer responds to the treatment. The study aims to understand how well Omomyc can stop or slow down the growth of the cancer. Patients will undergo regular check-ups, which may include imaging tests like MRI or CT scans, to track the progress of the treatment. The study will also look at how the treatment affects the overall quality of life of the participants.

Throughout the study, researchers will collect information on any side effects experienced by the participants to ensure the treatment is safe. The study will last for several months, and the results will help determine if Omomyc is a viable treatment option for patients with advanced high-grade osteosarcoma. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of Omomyc against no treatment. The findings from this study could provide valuable insights into new ways to treat this challenging form of cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, such as age and medical history.

A newly obtained tumor biopsy is required for patients over 16 years of age.

2 treatment administration

The medication OMO-103, also known as Omomyc, is administered through an intravenous infusion.

The form of the medication is a concentrate for solution for infusion.

3 monitoring and assessments

Regular monitoring includes assessments of tumor response using imaging techniques like CT or MRI.

Progression-free survival is evaluated at 16 weeks using specific criteria.

4 safety evaluations

Safety is assessed through routine monitoring of adverse events, laboratory tests, vital signs, physical examinations, and ECGs.

Adverse events are graded according to established criteria.

5 quality of life assessments

Health-related quality of life is measured using specific questionnaires for adults and younger patients.

The impact of treatment on daily life is evaluated.

6 end of study

The study is estimated to conclude by January 31, 2028.

Final assessments and data collection occur at the end of the study period.

Who Can Join the Study?

  • Must be at least 12 years old at the time of giving consent to participate.
  • Must have a confirmed diagnosis of advanced high-grade osteosarcoma, which is a type of bone cancer, and it should not be treatable with local treatments aimed at curing the disease.
  • The disease must have shown progression, meaning it has gotten worse, after receiving at least one standard chemotherapy treatment that includes cisplatin and anthracycline, but no more than two previous treatments.
  • Must have a disease that can be measured using specific criteria called RECIST v1.1, which involves imaging tests like CT or MRI scans.
  • For patients older than 16 years, a new sample of the tumor must be provided during the screening process and while on treatment. This sample can be from the original tumor or from areas where the cancer has spread.
  • Must have documented evidence that the disease has progressed after the last treatment received.
  • If a female patient is not postmenopausal or surgically sterile, or if a male patient has a female partner, they must agree to use at least one highly effective method of birth control, such as hormonal contraception, an IUD, abstinence, or condoms, starting at least one menstrual cycle before and continuing for three months after the last dose of the study drug.

Who Cannot Join the Study?

  • Patients with other types of cancer besides high-grade osteosarcoma cannot participate. Osteosarcoma is a type of bone cancer.
  • Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups only.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Patients who have any medical condition that the study doctors believe would make it unsafe for them to participate cannot join the study.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Hicbvosu Vazl dzwjewat Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not yet recruiting
02.09.2024

Trial locations

Investigated drugs:

OMO-103 is a medication being studied for its potential to treat advanced high-grade osteosarcoma, a type of bone cancer. It is administered intravenously, meaning it is given directly into a vein. The main goal of using OMO-103 in this trial is to evaluate its safety and its ability to reduce or stop the growth of tumors in patients with this condition.

Investigated diseases:

Advanced High-Grade Osteosarcoma – This is a type of bone cancer that typically occurs in the long bones of the body, such as the arms and legs. It is characterized by the production of immature bone by the cancer cells. The disease often presents with pain and swelling in the affected area, and it may lead to fractures. As it progresses, the cancer can spread to other parts of the body, most commonly the lungs. The progression of the disease can vary, but it generally involves an increase in tumor size and potential metastasis.

Trial ID:
2024-510987-22-00
Protocol code:
VHIO23003(OMO-103-03
Trial Phase:
Therapeutic exploratory (Phase II)

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