Drugs / Zanzalintinib
last change 3 days ago re-read 2 minutes ago

Zanzalintinib

Small molecule

Developed for
clear cell renal carcinoma · hepatocellular carcinoma · renal cell carcinoma · castration-resistant prostate carcinoma · metastatic neoplasm · bone sarcoma · colorectal cancer · head and neck squamous cell carcinoma
+35 more · leiomyosarcoma · non-small cell lung carcinoma · prostate carcinoma · soft tissue sarcoma · thyroid gland undifferentiated (anaplastic) carcinoma · urothelial carcinoma · cancer · colorectal carcinoma · endometrial cancer · Ewing sarcoma · germ cell tumor · head and neck neoplasm · hormone receptor-positive breast cancer · liposarcoma · malignant colon neoplasm · meningioma · metastatic carcinoma in the bone · metastatic malignant neoplasm · neuroendocrine neoplasm · nonpapillary renal cell carcinoma · olfactory neuroblastoma · oral cavity squamous cell carcinoma · osteosarcoma · pancreatic neuroendocrine tumor · paraganglioma · pheochromocytoma · poorly differentiated thyroid gland carcinoma · renal cell adenocarcinoma · salivary gland adenoid cystic carcinoma · squamous cell carcinoma · synovial sarcoma · thyroid cancer · thyroid carcinoma, nonmedullary, with or without cell oxyphilia · thyroid gland follicular carcinoma · thyroid gland papillary carcinoma
Investigated by
Exelixis · M.D. Anderson Cancer Center · National Cancer Institute (NCI) · Merck Sharp & Dohme LLC · Washington University School of Medicine · UNC Lineberger Comprehensive Cancer Center
+30 more · AdventHealth · Amit Mahipal · Anwaar Saeed · Arcus Biosciences, Inc. · City of Hope Medical Center · Columbia University · Dana-Farber Cancer Institute · Deepak Kilari · Devalingam Mahalingam · Guru Sonpavde · Hoffmann-La Roche · Indiana University · Jochen Lorch · Karie Runcie · Kelly Fitzgerald, MD · Medical College of Wisconsin · Northwell Health · Northwestern University · OHSU Knight Cancer Institute · Oregon Health and Science University · Pedro Barata, MD, MSc · Penn State Cancer Institute · Qian Qin · Regeneron Pharmaceuticals · Stuthi Perimbeti · UNICANCER · University of Chicago · University of Texas · University of Utah · Yonsei University

Trials 46 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 110 trials
Phase 1 NCT06968988 Jan 2026 → Feb 2029 expected soft tissue sarcoma Washington University School of Medicine Recruiting No outcome recorded
Phase 1 NCT06957431 Oct 2025 → May 2031 expected leiomyosarcoma, liposarcoma Washington University School of Medicine Recruiting No outcome recorded
Phase 1 NCT06795009 Oct 2025 → Nov 2029 expected endometrial cancer Washington University School of Medicine Recruiting No outcome recorded
Phase 1 NCT06912087 Sep 2025 → Jun 2027 expected head and neck neoplasm, metastatic neoplasm, squamous cell carcinoma University of Chicago Recruiting No outcome recorded
Phase 1 NCT06902376 Jun 2025 → Mar 2028 expected thyroid gland undifferentiated (anaplastic) carcinoma UNC Lineberger Comprehensive Cancer Center Recruiting No outcome recorded
Phase 1 NCT06962332 May → Dec 2025 overdue Exelixis Recruiting No outcome recorded
Phase 1 NCT06952010 May 2025 → May 2027 expected cancer, metastatic neoplasm Exelixis Recruiting No outcome recorded
Phase 1 NCT06191796 Jan 2024 → May 2025 clear cell renal carcinoma Exelixis Terminated No outcome recorded
Phase 1 NCT05176483 Dec 2021 → Jun 2030 expected castration-resistant prostate carcinoma, clear cell renal carcinoma, colorectal carcinoma, head and neck squamous cell carcinoma +3 Exelixis Recruiting No outcome recorded
Phase 1 NCT03845166 Mar 2019 → Aug 2026 overdue castration-resistant prostate carcinoma, colorectal cancer, hormone receptor-positive breast cancer, renal cell carcinoma Exelixis Active not recruiting No outcome recorded
Phase 1/24 trials
Phase 1/2 NCT07042919 Mar 2026 → Mar 2029 expected cirrhosis of liver, hepatocellular carcinoma Devalingam Mahalingam Recruiting No outcome recorded
Phase 1/2 NCT06937866 Nov 2025 → Mar 2030 expected germ cell tumor Indiana University Recruiting No outcome recorded
Phase 1/2 NCT07049926 Jul 2025 → Oct 2031 expected renal cell carcinoma Merck Sharp & Dohme LLC Recruiting No outcome recorded
Phase 1/2 NCT03337698 Dec 2017 → Oct 2025 non-small cell lung carcinoma Hoffmann-La Roche Terminated No outcome recorded
Phase 226 trials
Phase 2 NCT07714551 Jan 2027 → Jan 2031 expected paraganglioma, pheochromocytoma Dana-Farber Cancer Institute Not yet recruiting No outcome recorded
Phase 2 NCT07578025 Nov 2026 → Jun 2028 expected clear cell renal carcinoma City of Hope Medical Center Not yet recruiting No outcome recorded
Phase 2 NCT07691476 Oct 2026 → Oct 2028 expected nonpapillary renal cell carcinoma Yonsei University Not yet recruiting No outcome recorded
Phase 2 NCT07527169 Oct 2026 → Jul 2028 expected olfactory neuroblastoma M.D. Anderson Cancer Center Not yet recruiting No outcome recorded
Phase 2 NCT07682675 Oct 2026 → Apr 2029 expected metastatic neoplasm, salivary gland adenoid cystic carcinoma UNICANCER Not yet recruiting No outcome recorded
Phase 2 NCT07470489 Sep 2026 → Sep 2030 expected thyroid gland undifferentiated (anaplastic) carcinoma M.D. Anderson Cancer Center Not yet recruiting No outcome recorded
Phase 2 NCT07608718 Sep 2026 → May 2029 expected prostate carcinoma Pedro Barata, MD, MSc Not yet recruiting No outcome recorded
Phase 2 NCT07623460 Sep 2026 → Sep 2028 expected castration-resistant prostate carcinoma Stuthi Perimbeti Not yet recruiting No outcome recorded
Phase 2 NCT07677579 Aug 2026 → Aug 2028 expected malignant colon neoplasm Northwell Health Not yet recruiting No outcome recorded
Phase 2 NCT07218666 Jul 2026 → Jul 2028 expected prostate carcinoma Deepak Kilari Recruiting No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT06943755 Jul 2025 → Jun 2029 expected pancreatic neuroendocrine tumor Exelixis Recruiting No outcome recorded
Phase 2/3 NCT06082167 Jun 2024 → Aug 2028 expected head and neck squamous cell carcinoma Exelixis Active not recruiting No outcome recorded
Phase 34 trials
Phase 3 NCT07489495 Apr 2026 → Nov 2030 expected renal cell carcinoma Merck Sharp & Dohme LLC Recruiting No outcome recorded
Phase 3 NCT07227402 Nov 2025 → Feb 2032 expected renal cell carcinoma Merck Sharp & Dohme LLC Recruiting No outcome recorded
Phase 3 NCT05678673 Jan 2023 → Jul 2025 overdue renal cell adenocarcinoma Exelixis Active not recruiting No outcome recorded
Phase 3 NCT05425940 Sep 2022 → Jun 2026 overdue colorectal cancer Exelixis Active not recruiting No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 3 NCT07620574 Background May 2026 → May 2030 expected colorectal cancer, differentiated thyroid carcinoma, hepatocellular carcinoma, pancreatic neuroendocrine tumor +2 Exelixis Not yet recruiting No outcome recorded

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 48 sources stand behind the page.

FieldValueCited text
Known as Zanzalintinib “H&N NEO-COMBAT XL: Neoadjuvant XL-092 (Zanzalintinib) and Pembrolizumab (Keytruda) in Surgically Resectable, HPV Negative Oral Cavity Squamous Cell Carcinoma (OCSCC)” NCT07484139
42

“The TKI zanzalintinib (XL092) targets VEGFR, MET and TAM kinases, proteins that are involved in tumor growth, angiogenesis, metastasis and immunosuppression.” PMID 39041200 Jul 2024

“Trial of Zanzalintinib (XL092) in Combination With Immunotherapy in Patients Who Progress on Adjuvant Therapy in Clear Cell RCC” NCT06863311

“STELLAR-304: a phase III study of zanzalintinib (XL092) plus nivolumab in advanced non-clear cell renal cell carcinoma.” PMID 40008409 Feb 2025

NCT06082167

NCT07042919

NCT06926634

NCT07527169

NCT07227402

NCT07578025

NCT07226063

NCT07489495

NCT06191796

NCT07218666

NCT06968988

NCT06952010

NCT07049926

NCT07428616

NCT06795009

NCT07682675

NCT06959511

NCT06959641

NCT07623460

NCT07691476

NCT07620574

NCT07714551

NCT06794229

NCT06912087

NCT06571734

NCT05176483

NCT07193550

NCT07511504

NCT06943755

NCT07043608

NCT07677579

NCT07470489

NCT07608718

NCT07283731

NCT06957431

NCT06937866

NCT06698250

NCT06962332

NCT07185945

Known as XL-092 FUMARATE ChEMBL registry synonym — accepted as the source's own label CHEMBL5314428
Known as XL092 “H&N NEO-COMBAT XL: Neoadjuvant XL-092 (Zanzalintinib) and Pembrolizumab (Keytruda) in Surgically Resectable, HPV Negative Oral Cavity Squamous Cell Carcinoma (OCSCC)” NCT07484139
8

“The TKI zanzalintinib (XL092) targets VEGFR, MET and TAM kinases, proteins that are involved in tumor growth, angiogenesis, metastasis and immunosuppression.” PMID 39041200 Jul 2024

“Trial of Zanzalintinib (XL092) in Combination With Immunotherapy in Patients Who Progress on Adjuvant Therapy in Clear Cell RCC” NCT06863311

“STELLAR-304: a phase III study of zanzalintinib (XL092) plus nivolumab in advanced non-clear cell renal cell carcinoma.” PMID 40008409 Feb 2025

NCT06568562

NCT03337698

NCT07484139

NCT03845166

NCT06902376

Known as ZANZALINTINIB FUMARATE ChEMBL registry synonym — accepted as the source's own label CHEMBL5314428
Known as Zanzalintinib hemifumarate ChEMBL registry synonym — accepted as the source's own label CHEMBL5314428
Action Inhibit “It works by blocking certain proteins that play important roles in the development, growth and spread of cancer.” PMID 39041200 Jul 2024
Modality Small molecule “The TKI zanzalintinib (XL092) targets VEGFR, MET and TAM kinases” PMID 39041200 Jul 2024
Route Oral “XL092 is administered orally once a day on Day 1 to Day 21 of a 21 day cycle.” NCT03337698