Zanzalintinib

Generic Name: Zanzalintinib

Drug Type: Small Molecule

Chemical Formula: C_₂₉H_₂₅FN_₄O_₅

CAS Number: 2367004-54-2

Unique Ingredient Identifier: KC2JC2ZA04

Clinical Trials

Neoadjuvant Zanzalintinib Plus Nivolumab in Patients With Locally Advanced and/or Inoperable Clear Cell Renal Cell Carcinoma With or Without Non-measurable Metastasis

Phase 2

Not yet recruiting

Conditions: Locally Advanced Renal Cell Carcinoma

Interventions: Drug: Zanzalintinib
Drug: Nivolumab

First Posted Date: 2025-03-25

Last Posted Date: 2025-04-01

Lead Sponsor: Qian Qin

Target Recruit Count: 69

Registration Number: NCT06794229

Trial of XL092 in Combination With Immunotherapy in Patients Who Progress on Adjuvant Therapy in Clear Cell RCC

Phase 2

Recruiting

Conditions: Advanced Renal Cell Carcinoma
Metastatic Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma

Interventions: Drug: XL092
Drug: Nivolumab

First Posted Date: 2025-03-07

Last Posted Date: 2025-05-04

Lead Sponsor: Karie Runcie

Target Recruit Count: 70

Registration Number: NCT06863311

Locations: 🇺🇸
Columbia University Irving Medical Center, New York, New York, United States

Zanzalintinib in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer

Phase 1

Not yet recruiting

Conditions: Uterine Cancer
Endometrial Cancer

Interventions: Drug: Zanzalintinib
Drug: Paclitaxel

First Posted Date: 2025-01-27

Last Posted Date: 2025-04-25

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 36

Registration Number: NCT06795009

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States
🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States
🇺🇸
University of New Mexico, Albuquerque, New Mexico, United States

and more 1 locations

Zanzalintinib (XL-092) Plus Durvalumab and Tremelimumab in Unresectable Hepatocellular Carcinoma (ZENOBIA)

Phase 2

Recruiting

Conditions: Hepatocellular Carcinoma

Interventions: Drug: Zanzalintinib
Drug: Durvalumab
Drug: Tremelimumab

First Posted Date: 2024-11-20

Last Posted Date: 2025-01-06

Lead Sponsor: Anwaar Saeed

Target Recruit Count: 40

Registration Number: NCT06698250

Locations: 🇺🇸
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

XL092 (Zanzalintinib) for the Treatment of Patients With Metastatic or Unresectable Leiomyosarcoma

Phase 2

Recruiting

Conditions: Metastatic Leiomyosarcoma
Unresectable Leiomyosarcoma

Interventions: Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Echocardiography
Procedure: Multigated Acquisition Scan
Drug: Zanzalintinib

First Posted Date: 2024-08-26

Last Posted Date: 2024-10-30

Lead Sponsor: Northwestern University

Target Recruit Count: 29

Registration Number: NCT06571734

Locations: 🇺🇸
Northwestern University, Chicago, Illinois, United States

XL092 in Patients With Metastatic Castration-Resistant Prostate Cancer

Phase 2

Recruiting

Conditions: Metastatic Castration-resistant Prostate Cancer

Interventions: Drug: XL092

First Posted Date: 2024-08-23

Last Posted Date: 2024-12-13

Lead Sponsor: University of Utah

Target Recruit Count: 32

Registration Number: NCT06568562

Locations: 🇺🇸
Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, United States

Study of Zanzalintinib (XL092) + AB521 and Zanzalintinib + AB521 + Nivolumab in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Other Advanced Solid Tumors (STELLAR-009)

Phase 1

Recruiting

Conditions: Advanced Clear Cell Renal Cell Carcinoma or Other Advanced Solid Tumors

Interventions: Drug: zanzalintinib
Drug: AB521
Biological: Nivolumab

First Posted Date: 2024-01-05

Last Posted Date: 2024-08-07

Lead Sponsor: Exelixis

Target Recruit Count: 140

Registration Number: NCT06191796

Locations: 🇺🇸
Exelixis Site #8, Los Angeles, California, United States
🇺🇸
Exelixis Site #9, Miami, Florida, United States
🇺🇸
Exelixis Clinical Site #1, Orlando, Florida, United States

and more 11 locations

Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Phase 2

Recruiting

Conditions: Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Zanzalintinib-matched Placebo
Drug: Zanzalintinib
Biological: Pembrolizumab

First Posted Date: 2023-10-13

Last Posted Date: 2025-01-31

Lead Sponsor: Exelixis

Target Recruit Count: 600

Registration Number: NCT06082167

Locations: 🇲🇽
Exelixis Clinical Site #168, Guadalajara, Mexico
🇺🇸
Exelixis Clinical Site #2, Fullerton, California, United States
🇺🇸
Exelixis Clinical Site #1, Orange City, Florida, United States

and more 165 locations

Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma

Phase 3

Recruiting

Conditions: Non-Clear Cell Renal Cell Carcinoma

Interventions: Drug: Sunitinib Malate
Drug: XL092
Drug: Nivolumab

First Posted Date: 2023-01-10

Last Posted Date: 2024-12-17

Lead Sponsor: Exelixis

Target Recruit Count: 291

Registration Number: NCT05678673

Locations: 🇺🇸
Exelixis Clinical Site #164, Newport Beach, California, United States
🇺🇸
Exelixis Clinical Site #162, San Francisco, California, United States
🇺🇸
Exelixis Clinical Site #163, Aurora, Colorado, United States

and more 161 locations

Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer

Phase 3

Active, not recruiting

Conditions: Colorectal Cancer

Interventions: Drug: XL092
Drug: Regorafenib
Drug: Atezolizumab

First Posted Date: 2022-06-21

Last Posted Date: 2024-07-05

Lead Sponsor: Exelixis

Target Recruit Count: 874

Registration Number: NCT05425940

Locations: 🇺🇸
Exelixis Clinical Site #77, Los Angeles, California, United States
🇺🇸
Exelixis Clinical Site #106, Philadelphia, Pennsylvania, United States
🇺🇸
Exelixis Clinical Site #103, Pittsburgh, Pennsylvania, United States

and more 130 locations

Drug Development Updates

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