clinical trial · NCT07193550

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

M.D. Anderson Cancer Center·phase2·recruiting·n = 70

Bone SarcomasZanzalintinib

brief summary

To study the treatment efficacy of zanzalintinib monotherapy in patients with advanced and/or metastatic bone sarcomas.

started

Dec 5, 2025

primary completion

Oct 31, 2029

completion

Oct 31, 2031

last updated

Feb 27, 2026

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

full record on clinicaltrials.gov ↗

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