OST31-164 for Bone Cancer

(OST-164-01 Trial)

Not currently recruiting at 22 trial locations

Overseen By Jenn A Gargione

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Emerald Clinical Inc.

Must not be taking: Corticosteroids, Antibiotics, Chemotherapy, others

Disqualifiers: Metastatic disease, Active infection, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 19

Duration: 48 weeks

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. ^{1 2 3 4 5}

Why 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. ^{1 3 4 6 7}

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

Patients enrolled on AOST2031 are eligible for enrollment in the present study

Between 12 years of age and 39 years of age at the time the Informed Consent/ Assent form is signed

You have been diagnosed with osteosarcoma and had at least one tumor removed for confirmation.

Exclusion Criteria

Has concurrent pulmonary recurrence and local recurrence at the primary tumor site

You are currently taking part in another study involving an experimental drug or device, or have done so within the past 4 weeks.

You have an ongoing or severe autoimmune disease that requires medication to manage.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive OST31-164 infusions every 3 weeks for 48 weeks

48 weeks

16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Every 3 months

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?

Group I: OST31-164 Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Emerald Clinical Inc.

Lead Sponsor

George Clinical Pty Ltd

Lead Sponsor

Trials

15

Recruited

21,300+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04974008

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-osteosarcoma

OST-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 ...

3. ostherapies.com ostherapies.com/trials/

Clinical trials The primary goal of this study is to assess whether OST31-164 can help prevent or delay the recurrence of osteosarcoma.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11796608/

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-osteosarcoma

OST-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-metastases

OST-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 ...

7. businesswire.com businesswire.com/news/home/20240603141470/en/OS-Therapies-Announces-Positive-Clinical-Update-from-Ongoing-Phase-2b-Clinical-Trial-in-Resected-Recurrent-Osteosarcoma

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 ...