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Cabozantinib S

Phase 1

Infiltrating Bladder Urothelial Carcinoma With Squamous Differentiation | Small molecule | Oncology |Exelixis, Inc.|Last Updated: Apr 29, 2026

Target and mechanism

Molecular targetMET, KDR
Target classInhibitor
ModalitySmall molecule

Also known as Cabozantinib S-malate

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

Cabozantinib S · 1 trial · 4 indications

Phase 1 1
NCT04878029Cabozantinib in Combination With Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial CancerInfiltrating Bladder Urothelial Carcinoma With Squamous Differentiation
RECRUITING32 Analytics
PHASE1RECRUITING
Cabozantinib in Combination With Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Cancer
Infiltrating Bladder Urothelial Carcinoma With Squamous DifferentiationUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events
Up to study completion (estimated 5 years)

Will be assessed by the Common Terminology Criteria for Adverse Events version 5.0.

Secondary Endpoints

Objective response rate
Through study completion, an average of 1 year
Progression-free survival
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Overall survival
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment (cabozantinib, enfortumab vedotin)EXPERIMENTALPatients receive cabozantinib PO QD on days 1-28 and enfortumab vedotin IV on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Interventions

NameTypeDescription
Cabozantinib S-malateDRUGGiven PO
Enfortumab VedotinDRUGGiven IV
Quality-of-Life AssessmentOTHERAncillary studies
Questionnaire AdministrationOTHERAncillary studies
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Histologically-documented urothelial carcinoma (squamous differentiation or mixed cell types allowed if urothelial carcinoma is present) * Metastatic disease or unresectable locally-advanced disease * Must have received prior treatment with a checkpoint inhibitor (CPI). A CPI ...

Countries:United States
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Frequently asked questions about Cabozantinib S

What is Cabozantinib S used for?

Cabozantinib S is an investigational small molecule being studied for infiltrating bladder urothelial carcinoma with squamous differentiation, as well as locally advanced, metastatic, and unresectable urothelial carcinoma. It is currently in Phase 1 clinical development and has not been approved by the FDA.

What does Cabozantinib S target?

Cabozantinib S is a kinase inhibitor, belonging to the -tinib class of drugs. It is being studied in combination with enfortumab vedotin for the treatment of urothelial cancers, including infiltrating bladder urothelial carcinoma with squamous differentiation.

Who makes Cabozantinib S?

Cabozantinib S is being developed by Exelixis, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol EXEL. The company is conducting a Phase 1 clinical trial of the drug in the United States.

What phase is Cabozantinib S in?

Cabozantinib S is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The ongoing trial is actively recruiting participants in the United States.

What clinical trials is Cabozantinib S in?

Cabozantinib S is being studied in a single Phase 1 clinical trial, NCT04878029, titled 'Cabozantinib in Combination With Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Cancer.' The trial is recruiting 32 participants in the United States and is not randomized or blinded.

Is Cabozantinib S the same as Cabozantinib S-malate?

Yes, Cabozantinib S is also known as Cabozantinib S-malate. Both names refer to the same investigational drug being developed by Exelixis, Inc. for the treatment of urothelial carcinoma.