About this trial
To study the treatment efficacy of zanzalintinib monotherapy in patients with advanced and/or metastatic bone sarcomas.
Eligibility criteria
Qualifiers
Patients with conventional chondrosarcoma (Cohort C) must demonstrate evidence of disease progression by RECIST 1.1 within 12 weeks of trial enrollment
Patients must have relapsed or become refractory to conventional therapy, receiving at least 1 prior line of systemic therapy unless no standard of care exists.
Patients may have received no more than 2 prior lines of systemic therapy in the advanced/metastatic setting.
Multi-agent and/or alternating neoadjuvant/adjuvant standard of care chemotherapy will be counted as 1 line of systemic therapy if given for metastatic disease. Otherwise, neoadjuvant/adjuvant chemotherapy for localized disease does not apply towards the limitation regarding prior lines of systemic therapy.
Disqualifiers
Patients with primary soft tissue sarcoma with metastasis to bone.
Patients with known sensitivity to the study agents and/or previously identified allergy or hypersensitivity to components of treatment
Patients previously treated with other VEGF-targeted TKIs (including but not limited to cabozantinib, regorafenib, pazopanib, or similar).
Receipt of any small molecule kinase inhibitor (including investigational within 2 weeks before first dose of study treatment.
Trial design
Treatments tested in this trial
- Zanzalintinib
Treatment groups
Sponsors and collaborators
M.D. Anderson Cancer Center
Lead sponsor
Exelixis
Collaborator