Osteosarcoma Maintenance Therapy With OST31-164

Active:	No
Cancer Type:	Sarcoma	NCT ID:	NCT04974008
Trial Phases:	Phase II	Protocol IDs:	OST31-164-01 (AOST2121) (primary) NCI-2021-09179
Eligibility:	12 - 39 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	George Clinical Pty Ltd
NCI Full Details:	http://clinicaltrials.gov/show/NCT04974008

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.

Objectives

This is a Phase 2, open-label, multicenter, single-arm study in patients (12-39 years) with a
recent history of pulmonary recurrent osteosarcoma that has been completely resected. Planned
enrollment is a maximum of 45 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. Following treatment discontinuation, all patients will enter a 3-year survival
follow-up period. Exploratory evaluation of immune response will be conducted. If available,
tissue from the recent resection will be sent to the COG Biobank for future genomic and
pathologic analysis by the COG.

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