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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Zanzalintinib
DrugParticipants will take zanzalintinib 100mg daily by mouth
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: Phase 2 Cohorts A, B, C, D: Treatment with ZanzalintinibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame
Through study completion; an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
Exelixis
Collaborator
Source ClinicalTrials.gov