OST31-164 for Bone Cancer
(OST-164-01 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called OST31-164 for individuals with osteosarcoma, a type of bone cancer that has recurred in the lungs after surgery. The researchers aim to determine if this treatment can prevent the cancer from returning post-surgery. Participants will receive OST31-164 infusions every three weeks for about a year. Suitable candidates have experienced a recurrence of osteosarcoma in their lungs and have recently undergone surgery to remove it. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently on certain treatments like systemic antibiotics, corticosteroids, or chemotherapy. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that OST31-164 is likely to be safe for humans?
Research has shown that OST31-164 produced promising results in earlier studies. This treatment targets a specific protein called HER2, found on some cancer cells. In past research, OST31-164 improved survival rates for patients with osteosarcoma that had spread to the lungs.
Regarding safety, earlier studies in animals, such as dogs, showed that OST31-164 was well-tolerated. These studies led to provisional approval for treating osteosarcoma in dogs, suggesting it might be safe for humans as well, as it is now being tested in human trials.
While every treatment can have side effects, the positive results so far encourage OST31-164’s potential safety in humans. Since this trial is in an advanced phase, the treatment has demonstrated a reasonable safety profile in earlier studies.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for bone cancer, which typically include surgery, chemotherapy, and radiation, OST31-164 is a novel approach that uses a genetically modified bacterium to target cancer cells. This treatment works by stimulating the body's immune system to attack the cancer, offering a potentially more precise method than traditional therapies. Researchers are particularly excited about OST31-164 because it could reduce the need for more invasive treatments and minimize the side effects associated with standard cancer therapies.
What evidence suggests that OST31-164 might be an effective treatment for bone cancer?
Studies have shown that OST31-164 can extend the lives of patients with pulmonary metastatic osteosarcoma, a type of bone cancer that spreads to the lungs. Research indicates that this treatment has significantly improved survival rates in patients whose tumors have been surgically removed. OST31-164, which participants in this trial will receive, targets cancer cells specifically, making it a promising option for ongoing treatment. Early findings suggest it may help patients live at least 2 years longer after their tumors are fully removed. This treatment could prevent or delay the return of osteosarcoma, offering hope for those dealing with recurring bone cancer.13467
Who Is on the Research Team?
Robert Petit, PhD
Principal Investigator
OS Therapies, Inc.
Are You a Good Fit for This Trial?
This trial is for 12 to 39-year-olds with osteosarcoma that has recurred in the lungs and was surgically removed. They must have had at least one lung recurrence, weigh over 40 kg, and not be pregnant or breastfeeding. Participants need a performance status of ECOG scores of 0-2 and should understand the study's risks.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive OST31-164 infusions every 3 weeks for 48 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- OST31-164
Trial Overview
The trial tests OST31-164 infusions given every three weeks for a total of 48 weeks to patients who've had lung surgery for recurrent osteosarcoma. Their health will be monitored for three years after treatment.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients who will receive OST31-164 as a single agent every 3 weeks for 48 weeks with 4 doses constituting 1 treatment cycle (12 weeks per cycle). Each patient will receive treatment at a dose of 1x109 CFU until week 48 or until disease progression, unacceptable toxicity, or the patient meets any other treatment discontinuation criteria.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emerald Clinical Inc.
Lead Sponsor
George Clinical Pty Ltd
Lead Sponsor
Citations
Osteosarcoma Maintenance Therapy With OST31-164
Patients who will receive OST31-164 as a single agent every 3 weeks for 48 weeks with 4 doses constituting 1 treatment cycle (12 weeks per cycle).
2.
cancernetwork.com
cancernetwork.com/view/ost-her2-yields-significant-survival-in-pulmonary-metastatic-osteosarcomaOST-HER2 Yields Significant Survival in Pulmonary ...
Treatment with OST-HER2 (OST31-164) produced a statistically significant improvement in overall survival (OS) among a small cohort of patients ...
Clinical trials
The primary goal of this study is to assess whether OST31-164 can help prevent or delay the recurrence of osteosarcoma.
Targeted therapy for osteosarcoma: a review - PMC
Currently, the primary treatment for osteosarcoma is surgery combined with auxiliary multi-drug chemotherapy, after which the 5-year survival rate of patients ...
5.
onclive.com
onclive.com/view/ost-her2-displays-potential-os-benefit-in-recurrent-fully-resected-pulmonary-metastatic-osteosarcomaOST-HER2 Displays Potential OS Benefit in Recurrent ...
OST-HER2 produced a potential overall survival benefit at 2 years in recurrent, fully resected, pulmonary metastatic osteosarcoma.
6.
targetedonc.com
targetedonc.com/view/ost-her2-extends-12-month-efs-in-osteosarcoma-with-lung-metastasesOST-HER2 Extends 12-Month EFS in Osteosarcoma With ...
OST-HER2 (OST31-164), a HER2-targeted immunotherapy candidate, led to statistically significant 12-month event-free survival (EFS) results ...
OS Therapies Announces Positive Clinical Update from ...
OST31-164 has previously received USDA provisional approval for treatment of Osteosarcoma in canines. In a completed Phase III study in canines ...
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