Clinical Trials

If you are the parent or legal guardian of a child diagnosed with recurrent osteosarcoma (a type of bone cancer that has returned), you may be eligible for a new study evaluating OST31-164, a promising investigational treatment.

Doctor examining a little girl | OS Therapies

Study Purpose

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

Treatment Overview

Duration: Treatment involves four cycles over 48 weeks, with an intravenous infusion every three weeks. Each treatment cycle spans 12 weeks.
Follow-up: After treatment, you will receive periodic blood tests and evaluations for three years to monitor any potential infections.

Trial Locations

OS Therapies partners with top medical centers nationwide to make new osteosarcoma treatments more accessible. The locations shown on this map highlight where our clinical trials are actively taking place, offering families a nearby option to participate in this promising research.

Our technologies

What to Expect

The study drug, OST31-164, may cause mild or moderate flu-like side effects, including chills, fever, nausea, fatigue, and temporary changes in blood pressure. Side effects are generally short-lived and manageable with pre-treatment medication.

Participants will also receive antibiotics to prevent infections following each treatment session, with a blood culture check every three months during the follow-up period.

Required Tests & Procedures

Routine lab tests to monitor blood counts and health metrics

Imaging tests (MRI, CT, or X-ray) to track tumor status

Immune system analysis through periodic blood samples

Collection of previously removed tumor tissue for advanced research

These tests help us gain insights into the impact of OST31-164 on osteosarcoma and the immune system, aiming to improve outcomes for future patients.

Pediatrician meeting with parent and child | OS Therapies

OST31-164 Expanded Access Policy

OS Therapies is committed to delivering new, innovative immunotherapies to oncology patients by conducting rigorous clinical trials and obtaining market approval by the FDA and other regulatory authorities. In line with this commitment, we support expanded access programs when we have substantial scientific evidence to support the safety and efficacy for our therapies when it is logistically possible. Expanded access programs offer a lifeline to patients who have exhausted other treatment options and are ineligible for ongoing clinical studies, or patients involved in our clinical studies who seek continued treatment after the study has been completed.

This policy applies to OST31-164, an immunotherapy for pulmonary-recurrent pediatric osteosarcoma after resection. This policy applies during the active clinical development program of OST31-164 as well at the time period between regulatory approval of OST31-164 and its commercial availability in a country.

Patient eligibility criteria:

Suffer from pulmonary-recurrent osteosarcoma that has been completely resected;
Have undergone appropriate standard treatments without success and no comparable treatment is available/exists to treat the disease;
Are ineligible for participation in any ongoing clinical study of OST31-164 (including lack of access due to geographical constraints);
The projected benefit of the patient’s treatment outweighs the known or anticipated risks;
There is adequate information to support dosing for the individual patient.

Additionally, OS Therapies will consider the following when making a determination about delivery of OST31-164 under this policy:

There is adequate supply of OST31-164 available;
Making OST31-164 available will not negatively impact or delay the conduct of clinical trials, regulatory reviews, or approval of OST31-164 for broader patient access;
The requesting physician is properly licensed and must agree to comply with:
- Any applicable country specific legal and regulatory requirements related to providing an investigational product under expanded access;
- Any OS Therapies requirements in terms of medical criteria, safety reporting, drug supply/use and protection of intellectual property. A treating physician may submit questions or requests regarding expanded access to OS Therapies Chief Medical and Scientific Officer, Dr. Robert Petit (rp@ostherapies.com).

It is important to note that the Expanded Access Program of OST31-164 will be discontinued if any of the below criteria are met:

OST31-164 becomes commercially available and is therefore more broadly accessible to these patients;
A negative regulatory decision or OS Therapies decision to discontinue development of OST31-164;
New information becomes available about the activity or safety of OST31-164 that could substantially alter the benefit/risk profile for patients;
Limited supply of OST31-164 or manufacturing issues.

OS Therapies is committed to evaluating all requests in a fair and equitable manner. All requests must be submitted by the patients treating physician, and we may require more detailed information in order to fully evaluate a request. All requests will be carefully considered, and we strive to acknowledge all requests within 5 working days. All OS Therapies decisions are final.

Further information for OS Therapies ongoing clinical trials with OST31-164 can be found here.

Help Us Advance Osteosarcoma Research

By participating, you can contribute to our mission to identify and clinically validate new treatments for osteosarcoma. Located near NIH and FDA, OS Therapies is dedicated to advancing research in the Washington Metropolitan area’s vibrant biomedical community.