NCT07193550

A Phase 2 Trial of Zanzalintinib in Advanced/Metastatic Bone Sarcomas (ZAMBONE)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Bone Sarcomas

Interventions

Type	Name	Description
DRUG	Zanzalintinib	Participants will take zanzalintinib 100mg daily by mouth

Timeline

• Start date: 2025-12-05
• Primary completion: 2029-10-31
• Completion: 2031-10-31
• First posted: 2025-09-26
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study