A Phase 1 interventional study of Zanzalintinib in Cancer and Pediatric Cancer, sponsored by Exelixis. Not yet recruiting. Open to participants aged 12 Months to 17 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Exelixis · Phase 1, Interventional, and Treatment
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 18 is below the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Exelixis is the lead sponsor of 57 studies on the registry; 11 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive zanzalintinib oral tablets once daily (QD).
Drug: Zanzalintinib
Administered as specified in the treatment arm.
Also known as: XL092
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
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Zanzalintinib