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NCT Number: NCT07773454

Study of Zanzalintinib 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.

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Key information

Conditions

Cancer Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Disease Attributes Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroendocrine Tumors Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric Cancer Recurrence

Age range

12 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zanzalintinib

Drug

Administered as specified in the treatment arm.

Other names: XL092

Primary outcomes

  1. Number of Participants With Dose-Limiting Toxicities (DLTs)

    Time frame: Up to Day 28

  2. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to 8 months

Secondary outcomes

  1. Area Under the Concentration-Time Curve (AUC) of Zanzalintinib

    Time frame: From Week 1 Day 1 to Week 21 Day 1

  2. Maximum Plasma Concentration (Cmax) of Zanzalintinib

    Time frame: From Week 1 Day 1 to Week 21 Day 1

  3. Time to Maximum Plasma Concentration (Tmax) of Zanzalintinib

    Time frame: From Week 1 Day 1 to Week 21 Day 1

Study contacts

Contact information is provided by the study sponsor or research team.

Exelixis Clinical Trials

CONTACT

[email protected]

1-888-393-5494

Sponsors and collaborators

Lead sponsor

Exelixis

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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