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NCT07773454
Study of Zanzalintinib in Children and Adolescents With Relapsed or Refractory Solid Tumors
Conditions: Cancer, Pediatric Cancer
Sex: All
Ages: 12 Months – 17 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 18
Sponsor: Exelixis
Summary
The primary purpose of this study is to determine the pediatric maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), and to evaluate the safety and tolerability of zanzalintinib.
Eligibility Criteria
Key Inclusion Criteria:
* Participants must be \< 17 years old.
* Participants must have a minimum body weight of ≥ 10 kilograms (kg) at enrollment.
* Performance status of ≥ 50% as measured by Lansky for participants \< 16 years of age or Karnofsky for participants ≥ 16 years of age.
* Have a relapsed or refractory solid tumor, including primary CNS tumors (excluding lymphoma).
Key Exclusion Criteria:
* For participants with CNS primary tumors, evidence of intracranial or intratumoral hemorrhage are excluded.
* Diagnosis of lymphoma.
* Lesions invading major blood vessels including, but not limited to, inferior vena cava, pulmonary artery, or aorta.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Source: ClinicalTrials.gov (NCT07773454). StuddyBuddy aggregates publicly available trial information.