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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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study searching for new participants at this time?

"Yes, this information can be found on clinicaltrials.gov. This particular trial was originally posted on October 21st 2021 and has since been updated on October 31st 2022."

Answered by AI

Are the age requirements for participants in this trial flexible?

"According to the inclusion criteria laid out by the study, patients between 12 and 39 years old are eligible. There are 114 other trials for patients younger than 12 and 85 trials for patients older than 65."

Answered by AI

Is this clinical trial only taking place in the United States?

"There are 23 sites for this trial, with the primary locations being Ann & Robert H. Lurie Children's Hospital of Chicago in Chicago, Illinois; Connecticut Children's in Hartford, Connecticut; and Children's Hospital of Philadelphia in Philadelphia, Pennsylvania."

Answered by AI

Are there any risks associated with exposure to OST31-164?

"There is limited data surrounding the safety of OST31-164, as this is only a Phase 2 trial. This suggests that while there have been no studies conducted observing its efficacy, there have been some studies completed which support its safety."

Answered by AI

What are the guidelines for who can enroll in this trial?

"This clinical trial is recruiting 45 people with osteosarcoma between the ages of 12 and 39. Most notable, applicants are required to meet the following criteria: Note: Patients enrolled on AOST2031 are eligible for enrollment in the present study., Age and Weight, Between 12 years of age and 39 years of age at the time the Informed Consent/ Assent form is signed., Weight at least 40 kg. Diagnosis, Has histologic confirmation of osteosarcoma at diagnosis., Surgical resection of all possible sites of suspected pulmonary metastases to achieve a complete remission within 8 weeks prior to study enrollment"

Answered by AI

How many people are allowed to be a part of this research project?

"45 individuals that meet the specific requirements set forth by the study's designers need to enroll. This research is being conducted across multiple sites, like Ann & Robert H. Lurie Children's Hospital of Chicago in Chicago, Illinois and Connecticut Children's in Hartford, Connecticut."

Answered by AI
~11 spots leftby Apr 2025