OST31-164 for Bone Cancer
(OST-164-01 Trial)

Recruiting in Palo Alto (17 mi)

+20 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: George Clinical Pty Ltd

No Placebo Group

Prior Safety Data

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.

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.

+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.

+19 more

Participant Groups

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.

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.