HCRN withdraws phase 2 zanzalintinib trial in advanced urothelial carcinoma
The funder pulled support for the single-arm study before any participants enrolled, according to the ClinicalTrials.gov record last updated November 9, 2026.
A Phase II trial testing zanzalintinib in advanced urothelial carcinoma has been withdrawn, according to a ClinicalTrials.gov record for "Phase II Trial of Zanzalintinib for Advanced Urothelial Carcinoma Progressing After Prior Therapy" (NCT07185945), last updated November 9, 2026. The listed reason for stopping was that the funder withdrew support.1
The trial's estimated start date was October 2026, with an estimated primary completion date of June 2027 and estimated study completion of June 2029, according to the record. The last update, posted in November 2026, came after the estimated start date had passed but before the estimated primary completion date.
Imaging was planned every 8 weeks for three timepoints, then every 12 weeks afterward.1
The planned primary outcome was objective response rate over a 24-month time frame, defined as the proportion of patients achieving a confirmed complete or partial response per RECIST 1.1.1 Planned secondary outcomes included progression-free survival, duration of response, overall survival, and number of participants with adverse events, each over a 24-month time frame.1
Eligibility criteria called for patients with progressive disease by RECIST 1.1 following one to three lines of prior therapy, with prior lines required to include enfortumab vedotin and a PD(L)1 inhibitor unless a patient was ineligible for either.1 The record was first posted September 22, 2025.
Fact check notes
- Imprecise
HCRN withdraws phase 2 zanzalintinib trial in advanced urothelial carcinoma
The record lists sponsor as 'Guru Sonpavde' (individual) with collaborators Exelixis and Advent Health; 'HCRN' only appears as part of the sponsor study ID (HCRN GU23-633). The source does not explicitly name HCRN as the entity that withdrew the trial, making this an inference rather than a directly supported fact. - Checker's noteHeadline attributes the withdrawal decision to 'HCRN,' but the source lists the lead sponsor as an individual (Guru Sonpavde) with Exelixis and Advent Health as collaborators; HCRN appears only within the study ID, not as a named funder/sponsor entity in the record.
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The study, sponsored by Guru Sonpavde with Exelixis and Advent Health listed as collaborators, recorded an enrollment of 0 participants.
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As designed, the single-arm study would have given all subjects zanzalintinib 60 mg orally once daily until progression per RECIST 1.1 or intolerable toxicities or patient/investigator decision to discontinue study therapy.
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Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Where the check questioned a sentence, its note is shown above. Not investment advice.