Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-29 @ 12:27 AM
Study NCT ID:
NCT07193550
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 2 Trial of Zanzalintinib in Advanced/Metastatic Bone Sarcomas (ZAMBONE)
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Phase 2 Trial of Zanzalintinib in Advanced/Metastatic Bone Sarcomas (ZAMBONE)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To study the treatment efficacy of zanzalintinib monotherapy in patients with advanced and/or metastatic bone sarcomas.
Detailed Description:
Primary Objectives:
* For cohort A (osteosarcoma) progression-free survival (PFS) rate at 16 weeks (PFS16 weeks)
* For cohort B (Ewing sarcoma), cohort C (chondrosarcoma), and cohort D (other bone sarcomas), progression-free survival (PFS) at 12 weeks (PFS12 weeks).
Secondary Objectives:
* To estimate the objective response rate (ORR) within each cohort by RECIST 1.1 criteria.
* To estimate the progression-free survival (PFS) and overall survival in patients with locally advanced or metastatic bone sarcomas receiving zanzalintinib.
* To evaluate the safety and tolerability of zanzalintinib within each cohort and across cohorts as assessed by toxicity rates according to CTCAE version 5.0 criteria.
Exploratory Objectives:
To determine the expression of selected biomarkers in pre-treatment and on-treatment tumor biopsy specimens and correlate with clinical benefit within each cohort and across cohorts
* For cohort A (osteosarcoma) progression-free survival (PFS) rate at 16 weeks (PFS16 weeks)
* For cohort B (Ewing sarcoma), cohort C (chondrosarcoma), and cohort D (other bone sarcomas), progression-free survival (PFS) at 12 weeks (PFS12 weeks).
Secondary Objectives:
* To estimate the objective response rate (ORR) within each cohort by RECIST 1.1 criteria.
* To estimate the progression-free survival (PFS) and overall survival in patients with locally advanced or metastatic bone sarcomas receiving zanzalintinib.
* To evaluate the safety and tolerability of zanzalintinib within each cohort and across cohorts as assessed by toxicity rates according to CTCAE version 5.0 criteria.
Exploratory Objectives:
To determine the expression of selected biomarkers in pre-treatment and on-treatment tumor biopsy specimens and correlate with clinical benefit within each cohort and across cohorts
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: