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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

OST-164-01 Trial Summary

This trial is for patients with osteosarcoma who have had surgery to remove the cancer from their lungs, and will be receiving OST31-164 infusions every 3 weeks for 48 weeks.

Eligible Conditions
  • Bone Cancer

OST-164-01 Trial 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

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

OST-164-01 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
21,253 Total Patients Enrolled
Robert Petit, PhDStudy DirectorOS Therapies, Inc.
1 Previous Clinical Trials
36 Total Patients Enrolled
~11 spots leftby Jun 2025
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