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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-Escalation Study of XL092 in Children and Adolescents With Relapsed or Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT07773454
- Acronym / sponsor ID
- XL092-011
- Conditions
- Cancer, Pediatric Cancer
- Keywords
- Solid tumors, Brain tumors, Nervous system tumors, Relapsed, Refractory, Sarcoma and/or osteosarcoma, Central nervous system (CNS), Neuroendocrine tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- ExelixisIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zanzalintinib | Experimental | Drug: ZanzalintinibParticipants will receive zanzalintinib oral tablets once daily (QD). |
Who may qualify
- Ages
- 12 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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 (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZanzalintinibAlso: XL092Administered as specified in the treatment arm. | Drug | Zanzalintinib |
Primary outcome
Number of Participants With Dose-Limiting Toxicities (DLTs)
Time frame: Up to Day 28
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 8 months
3 secondary outcomes
Area Under the Concentration-Time Curve (AUC) of Zanzalintinib
Time frame: From Week 1 Day 1 to Week 21 Day 1
Maximum Plasma Concentration (Cmax) of Zanzalintinib
Time frame: From Week 1 Day 1 to Week 21 Day 1
Time to Maximum Plasma Concentration (Tmax) of Zanzalintinib
Time frame: From Week 1 Day 1 to Week 21 Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Exelixis
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zanzalintinib in people with Cancer and Pediatric Cancer, run by Exelixis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Exelixis Clinical Trials (1-888-393-5494, druginfo@exelixis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose-Limiting Toxicities (DLTs) (time frame: Up to Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.