Clinical Trials

Multiple clinical trials ranging from Early Phase 1 through Phase 3 have evaluated sitravatinib (MGCD516) for pharmacokinetic profiles and therapeutic efficacy across diverse malignancies, including non-small cell lung cancer, renal cell carcinoma, and advanced solid tumors. Conducted by pharmaceutical sponsors such as Mirati Therapeutics and BeiGene alongside major academic institutions, these investigations encompass active, completed, terminated, and withdrawn statuses. Key late-stage and combination evaluations continue to assess the agent in healthy adults, hepatically impaired subjects, and broad oncology patient cohorts.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05564338 WITHDRAWN
Hepatocellular Carcinoma
BeiGene
 2023-06-30 PHASE3
NCT05407519 UNKNOWN
Hepatocellular Carcinoma
Anhui Provincial Hospital
 2022-07-25 PHASE2
NCT04164199 COMPLETED
Advanced Malignancies
BeOne Medicines
 2019-12-19 PHASE3
NCT04904302 TERMINATED
Advanced Clear Cell Renal Cell Carcinoma; Metastatic Clear Cell Renal Cell Carcinoma; Stage IV Renal Cell Cancer AJCC v8
M.D. Anderson Cancer Center
 2022-05-03 PHASE2
NCT05419817 WITHDRAWN
Recurrent Endometrial Cancer; Solid Tumors
Haider Mahdi
 2022-09-08 PHASE2
NCT04887870 COMPLETED
Advanced or Metastatic Solid Malignancies
Mirati Therapeutics Inc.
 2021-06-29 PHASE2; PHASE3
NCT04734262 UNKNOWN
Metastatic Breast Cancer
Fudan University
 2021-04-01 PHASE2
NCT05461794 TERMINATED
Esophageal Squamous Cell Carcinoma
BeiGene
 2022-10-03 PHASE2
NCT05542342 COMPLETED
Uveal Melanoma With Liver Metastases
Grupo Español Multidisciplinar de Melanoma
 2022-09-23 PHASE2
NCT04921358 TERMINATED
Non-Small Cell Lung Cancer (NSCLC)
BeiGene
 2021-07-27 PHASE3
NCT02664935 COMPLETED
Non-Small Cell Lung Cancer; Carcinoma, Squamous Cell; Adenocarcinoma
University of Birmingham
 2015-05-13 PHASE2
NCT05104801 UNKNOWN
Melanoma
Peking University Cancer Hospital & Institute
 2021-11 PHASE2
NCT04727996 UNKNOWN
Advanced Biliary Tract Cancer
Seoul National University Hospital
 2020-11-01 PHASE2
NCT05228496 UNKNOWN
Lung Cancer, Small Cell
Zhejiang Cancer Hospital
 2022-03-17 PHASE2
NCT04518046 COMPLETED
Clear-Cell Renal Cell Carcinoma
Mirati Therapeutics Inc.
 2020-08-11 PHASE1
NCT04925986 TERMINATED
Carcinoma, Non-Small-Cell Lung; Lung Diseases; Lung Neoplasms; Metastatic Lung Non-Small Cell Carcinoma; Stage IV Lung Non-Small Cell Cancer AJCC v7; PD-L1 Gene Mutation; Advanced Treatment-Naïve PD-L1; Sitravatinib; Pembrolizumab
Sarah Goldberg
 2022-02-10 PHASE2
NCT05614453 WITHDRAWN
Metastatic Cervical Cancer
Australia New Zealand Gynaecological Oncology Group
 2023-06 PHASE2
NCT03941873 COMPLETED
Carcinoma, Hepatocellular; Gastric/Gastroesophageal Junction Cancer
BeiGene
 2019-02-28 PHASE1; PHASE2
NCT03906071 COMPLETED
Metastatic Non-Squamous Non-Small Cell Lung Cancer
Mirati Therapeutics Inc.
 2019-07-15 PHASE3
NCT04123704 TERMINATED
Breast Cancer Stage IV; Triple Negative Breast Cancer; Breast Neoplasms; Breast Cancer Metastatic
Xiang Zhang
 2021-09-22 PHASE2
NCT03666143 COMPLETED
Advanced Solid Tumors
BeiGene
 2018-11-01 PHASE1
NCT04887194 COMPLETED
Advanced Solid Tumor
Mirati Therapeutics Inc.
 2021-04-08 PHASE1
NCT03015740 COMPLETED
Clear Cell Renal Cell Carcinoma; Metastatic Kidney Carcinoma; Stage III Renal Cell Cancer AJCC v7; Stage IV Renal Cell Cancer AJCC v7
M.D. Anderson Cancer Center
 2017-04-23 PHASE1; PHASE2
NCT03606174 TERMINATED
Urothelial Carcinoma; Urothelial Carcinoma Bladder; Urothelial Carcinoma Ureter; Urothelial Carcinoma of the Renal Pelvis and Ureter; Urothelial Carcinoma Urethra
Mirati Therapeutics Inc.
 2018-09-11 PHASE2
NCT04772612 COMPLETED
Hepatic Impairment
Mirati Therapeutics Inc.
 2021-03-12 PHASE1
NCT05176925 TERMINATED
Non-small Cell Lung Cancer
Fudan University
 2021-01-10 PHASE2
NCT05255276 COMPLETED
Healthy Adults
Mirati Therapeutics Inc.
 2022-02-02 PHASE1
NCT02219711 COMPLETED
Advanced Cancer
Mirati Therapeutics Inc.
 2014-08 PHASE1
NCT02954991 TERMINATED
Carcinoma, Non-Small-Cell Lung
Mirati Therapeutics Inc.
 2016-11-07 PHASE2
NCT04935112 COMPLETED
Healthy Adults
Mirati Therapeutics Inc.
 2021-07-07 PHASE1
NCT04800614 COMPLETED
Healthy Adults
Mirati Therapeutics Inc.
 2021-03-15 PHASE1
NCT04935112 Completed
Healthy Adults
Mirati Therapeutics Inc.
 2021-07-07 Phase 1
NCT04921358 Terminated
Non-Small Cell Lung Cancer (NSCLC)
BeiGene
 2021-07-27 Phase 3
NCT04772612 Completed
Hepatic Impairment
Mirati Therapeutics Inc.
 2021-03-12 Phase 1
NCT04800614 Completed
Healthy Adults
Mirati Therapeutics Inc.
 2021-03-15 Phase 1
NCT04472650 COMPLETED
Tumor
BeiGene
 2020-07-23 PHASE1
NCT03680521 COMPLETED
Clear Cell Renal Cell Carcinoma
Mirati Therapeutics Inc.
 2018-10-10 PHASE2
NCT03575598 COMPLETED
Squamous Cell Carcinoma, Head And Neck; Squamous Cell Carcinoma Mouth; Squamous Cell Carcinoma of the Oral Cavity
University Health Network, Toronto
 2018-08-30 EARLY_PHASE1
NCT02978859 COMPLETED
Liposarcoma; Metastatic Liposarcoma
Columbia University
 2016-11 PHASE2

(data from https://clinicaltrials.gov, updated on 2023-06-07)

Check the Sitravatinib (MGCD516) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sitravatinib is a multi-kinase inhibitor that selectively binds to and inhibits receptor tyrosine kinases, including c-Kit, PDGFRα/β, c-Met, and Axl, thereby disrupting downstream oncogenic signaling cascades and suppressing cell proliferation and survival. By blocking these receptor pathways, sitravatinib attenuates pro-survival signaling within the tumor microenvironment, providing clinical relevance in the treatment of advanced solid tumors, non-small cell lung cancer, and renal cell carcinoma.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.