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

NCT07773454 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: XL092-011
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cancer; Pediatric Cancer

Keywords

Solid tumors; Brain tumors; Nervous system tumors; Relapsed; Refractory; Sarcoma and/or osteosarcoma; Central nervous system (CNS); Neuroendocrine tumors; Progressed; Brain

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Dose-Limiting Toxicities (DLTs)

  Up to Day 28

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

  Up to 8 months

Secondary Outcomes (3)

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

  From Week 1 Day 1 to Week 21 Day 1

• Maximum Plasma Concentration (Cmax) of Zanzalintinib

  From Week 1 Day 1 to Week 21 Day 1

• Time to Maximum Plasma Concentration (Tmax) of Zanzalintinib

  From Week 1 Day 1 to Week 21 Day 1

Study Arms (1)

Zanzalintinib

EXPERIMENTAL

Participants will receive zanzalintinib oral tablets once daily (QD).

Drug: Zanzalintinib

Interventions

Zanzalintinib DRUG

Administered as specified in the treatment arm.

Also known as: XL092

Zanzalintinib

Eligibility Criteria

• Age: 12 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Exelixis: lead

MeSH Terms

Conditions

Neoplasms; Brain Neoplasms; Nervous System Neoplasms; Recurrence; Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

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

Study Officials

• Medical Director

  Exelixis

  STUDY DIRECTOR

Central Study Contacts

Exelixis Clinical Trials

CONTACT

1-888-393-5494; druginfo@exelixis.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 19, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share