Osteosarcoma Maintenance Therapy With OST31-164

NCT04974008 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: OST31-164-01 (AOST2121)
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 21

Brief Summary

Up to 45 Patients aged 12 to 39 with osteosarcoma (bone cancer) that had recurred in the lungs and has recently been surgically removed will be enrolled. Patients will receive OST31-164 infusions every 3 weeks over 48 weeks and be followed after that for 3 years.

Conditions

Bone Cancer

Keywords

Osteosarcoma; Bone Cancer

Outcome Measures

Primary Outcomes (1)

• Event-Free Survival

  The relative proportion of patients experiencing event-free (recurrence-free) survival at 12 months, compared to historical controls. Patients will be e valuated for recurrence every 3 months, consistent with the standard of care.

  Every 3 months, up to one year

Secondary Outcomes (1)

• Overall Survival

  Every 3 months, up to 3 years

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Throughout the treatment period of 48 weeks, then every 3 months for 3 years

Study Arms (1)

OST31-164

EXPERIMENTAL

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.

Drug: OST31-164

Interventions

OST31-164 DRUG

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.

OST31-164

Eligibility Criteria

• Age: 12 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Note: Patients enrolled on AOST2031 are eligible for enrollment in the present study.
• Patients are eligible to be included in the study only if all the following criteria apply:
• 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.
• Has at least one episode of disease recurrence in the lungs without limitation on the number of episodes of recurrence as long as the following criteria are met:
• Surgical resection of all possible sites of suspected pulmonary metastases to achieve a complete remission within 8 weeks prior to study enrollment
• Pathological confirmation of osteosarcoma from at least one resected tumor.
• Patients will not require radiographic confirmation of complete remission for enrollment. However, a postoperative CT chest scan is required as a baseline for future comparisons.
• https://members.childrensoncologygroup.org/files/Disc/surgery/handbooks/OsteoBoneHandbook.pdf) Performance Status
• Patient must have a performance status corresponding to ECOG scores of 0, 1, or 2. Use Karnofsky scale for patients \> 16 years of age and Lansky scale for patients \< years of age Prior Therapy
• Patient must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, radiotherapy, or surgery prior to entering this study.
• Organ Function Requirements
• Patient has adequate organ function as defined below:

You may not qualify if:

• Has clinically evident metastatic or recurrent disease.
• Has concurrent pulmonary recurrence and local recurrence at the primary tumor site.
• Has primary refractory disease with progression of the primary tumor on initial-therapy.
• Has CNS or any extrapulmonary disease involvement at the time of the most recent episode of disease recurrence proceeding enrollment.
• Has active infection requiring systemic therapy or is dependent on or is currently receiving systemic antibiotics that cannot be discontinued before dosing. (Note: Patients who discontinue an antibiotic prior to dosing must wait at least 5 half-lives after the last dose of antibiotic before receiving any OST31-164 infusion). Inhaled prophylactic PJP (pneumocystis jiroveci pneumonia) treatment is acceptable per Investigator discretion.
• Is currently dependent on or has received corticosteroids within the past 4 weeks (topical corticosteroids and occasional inhaled corticosteroids are allowed).
• Is currently participating in or has participated in a study of an investigational agent or is using an investigational device within 4 weeks of the first dose of treatment.
• Has a history of other active malignancy for \< 2 years prior to enrollment. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy or is felt by the Investigator to be at low risk for recurrence is allowed.
• Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Patients who require intermittent use of bronchodilators or local steroid injections will not be excluded from the study. Patients with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of study treatment.
• Has a known allergy to any component of the study treatment(s) formulations.
• Has a contraindication (e.g., sensitivity/allergy) to both trimethoprim/ sulfamethoxazole and amoxicillin.
• Has contraindication to administration of NSAIDs.
• Is currently receiving or will be receiving any chemotherapy, including PI3K inhibitors, during the treatment phase.

Sponsors & Collaborators

• Emerald Clinical Inc.: lead

Study Sites (21)

Kaiser Permanente Downey Medical Center

Los Angeles, California, 90027, United States

Location

Children's Hospital of Orange County

Orange, California, 92057, United States

Location

Rady Children's Hospital

San Diego, California, 92123, United States

Location

Children's Hospital of Colorado

Aurora, Colorado, 80045, United States

Location

Connecticut Children's

Hartford, Connecticut, 06106, United States

Location

Nemours/ Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Johns Hopkins Medical Center

Baltimore, Maryland, 21287, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Bone Neoplasms; Osteosarcoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Sarcoma

Study Officials

• Robert Petit, PhD

  OS Therapies, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 22, 2021
• Study Start: October 21, 2021
• Primary Completion: September 21, 2023
• Study Completion (Estimated): October 31, 2027
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)