CancerPhase 1NCT07773454
Study of Zanzalintinib in Children and Adolescents With Relapsed or Refractory Solid Tumors
A Phase 1 study testing Zanzalintinib in people with Cancer and Pediatric Cancer, run by Exelixis.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 months to 17 years
- Conditions the study is for
- Cancer, Pediatric Cancer
- What is being tested?
- Zanzalintinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 31 Jul 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Cancer, Pediatric Cancer
- Being tested
- Zanzalintinib
- Keywords
- Solid tumors, Brain tumors, Nervous system tumors, Relapsed, Refractory, Sarcoma and/or osteosarcoma, Central nervous system (CNS), Neuroendocrine tumors, Progressed, Brain
- Medical subject headings
- Neoplasms, Brain Neoplasms, Nervous System Neoplasms, Recurrence, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanzalintinibDrug
Also called XL092
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Zanzalintinib | Experimental | Participants will receive zanzalintinib oral tablets once daily (QD). Receives: Drug: Zanzalintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-Limiting Toxicities (DLTs)
Measured: Up to Day 28
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to 8 months
Secondary outcomes (3)
Area Under the Concentration-Time Curve (AUC) of Zanzalintinib
Measured: From Week 1 Day 1 to Week 21 Day 1
Maximum Plasma Concentration (Cmax) of Zanzalintinib
Measured: From Week 1 Day 1 to Week 21 Day 1
Time to Maximum Plasma Concentration (Tmax) of Zanzalintinib
Measured: From Week 1 Day 1 to Week 21 Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by ExelixisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exelixis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Exelixis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773454
- Sponsor's protocol ID
- XL092-011
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No