Study of Zanzalintinib in Children and Adolescents With Relapsed or Refractory Solid Tumors

A Phase 1 Dose-Escalation Study of XL092 in Children and Adolescents With Relapsed or Refractory Solid Tumors

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.

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.