39 Participants Needed

OST31-164 for Bone Cancer

(OST-164-01 Trial)

Recruiting at 20 trial locations
JL
JA
JA
Overseen ByJenn A Gargione
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial involves giving OST31-164 infusions to patients aged 12 to 39 with bone cancer that has returned in the lungs and been surgically removed. The treatment helps the immune system fight any leftover cancer cells. Patients will receive infusions periodically for several months and be monitored for a few years.

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.

How is the drug OST31-164 different from other treatments for bone cancer?

OST31-164 is unique because it represents a novel approach to treating bone cancer, potentially offering a new mechanism of action compared to traditional chemotherapy, surgery, and radiation, which have not significantly improved survival rates in recent decades.12345

Research Team

RP

Robert Petit, PhD

Principal Investigator

OS Therapies, Inc.

Eligibility Criteria

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.
See 22 more

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.
See 19 more

Timeline

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

Treatment Details

Interventions

  • OST31-164
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: OST31-164Experimental Treatment1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

George Clinical Pty Ltd

Lead Sponsor

Trials
15
Recruited
21,300+

References

Longitudinal patterns of bone-targeted agent use among patients with solid tumors and bone metastases in the United States. [2022]
Emerging drugs for high-grade osteosarcoma. [2022]
Treatment of non-metastatic high-grade osteosarcoma (study of 30 cases treated with Scandinavian osteosarcoma protocol XIV and surgery). [2016]
Assessment of bone-targeting agents use in patients with bone metastasis from breast, lung or prostate cancer using structured and unstructured electronic health records from a regional UK-based hospital. [2023]
Current therapeutic strategies and novel approaches in osteosarcoma. [2022]