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

ConditionBone Sarcomas
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

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

70 Participants
are divided into 1 treatment group

Sponsors and collaborators