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

Phase 2
Waitlist Available
Research Sponsored by George Clinical Pty Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the treatment period of 48 weeks, then every 3 months for 3 years
Awards & highlights
No Placebo-Only Group

Summary

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.

Eligible Conditions
  • Bone Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the treatment period of 48 weeks, then every 3 months for 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the treatment period of 48 weeks, then every 3 months for 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Event-Free Survival
Secondary study objectives
Overall Survival
Other study objectives
Incidence of Treatment-Emergent Adverse Events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OST31-164
2021
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

George Clinical Pty LtdLead Sponsor
13 Previous Clinical Trials
21,238 Total Patients Enrolled
Robert Petit, PhDStudy DirectorOS Therapies, Inc.
2 Previous Clinical Trials
72 Total Patients Enrolled
~10 spots leftby Dec 2025
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