Savolitinib is being evaluated across numerous clinical trials spanning Phase 1 to Phase 3, primarily addressing oncological conditions such as MET-driven papillary renal cell carcinoma, non-small cell lung cancer, lung sarcomatoid carcinoma, colorectal cancer, and advanced solid tumors, alongside pharmacokinetic studies in healthy subjects. Led by industry sponsors like AstraZeneca and Hutchison Medipharma in partnership with academic institutions such as the National Cancer Institute, Yale University, and UNICANCER, these studies encompass active recruiting, completed, active not recruiting, and withdrawn statuses.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07683403 | NOT_YET_RECRUITING | Colorectal Cancer (CRC) |
Fudan University |
2026-06-30 | PHASE1; PHASE2 |
| NCT05009836 | ACTIVE_NOT_RECRUITING | Non-small Cell Lung Cancer |
Hutchison Medipharma Limited |
2021-09-06 | PHASE3 |
| NCT06692491 | NOT_YET_RECRUITING | Rare Tumour |
Peking University Shenzhen Hospital |
2025-01-01 | PHASE2 |
| NCT06563999 | RECRUITING | Lung Cancer Stage III; Mutation |
Sun Yat-sen University |
2024-11-01 | PHASE2 |
| NCT05777278 | RECRUITING | Non-small Cell Lung Cancer |
The First Affiliated Hospital of Guangzhou Medical University |
2023-07-26 | PHASE1; PHASE2 |
| NCT05374603 | ACTIVE_NOT_RECRUITING | Lung Cancer |
AstraZeneca |
2022-11-15 | PHASE2 |
| NCT07322783 | RECRUITING | EGFR Positive Non-small Cell Lung Cancer; MET Amplification |
Qingdao Central Hospital |
2025-01-01 | PHASE2 |
| NCT04322890 | RECRUITING | Non Small Cell Lung Cancer; EGFR Gene Mutation; ALK Gene Mutation; ROS1 Gene Mutation; MET Gene Mutation |
Hunan Province Tumor Hospital |
2020-04-16 | PHASE2 |
| NCT05620628 | RECRUITING | Stomach Cancer, Adenocarcinoma |
Jeeyun Lee |
2023-01-05 | PHASE2 |
| NCT05261399 | ACTIVE_NOT_RECRUITING | Carcinoma; Non-Small-Cell Lung |
AstraZeneca |
2022-08-03 | PHASE3 |
| NCT03598244 | ACTIVE_NOT_RECRUITING | Recurrent Diffuse Intrinsic Pontine Glioma; Recurrent Malignant Glioma; Recurrent Medulloblastoma; Recurrent Primary Central Nervous System Neoplasm; Refractory Diffuse Intrinsic Pontine Glioma; Refractory Malignant Glioma; Refractory Medulloblastoma; Refractory Primary Central Nervous System Neoplasm |
National Cancer Institute (NCI) |
2018-11-27 | PHASE1 |
| NCT04923932 | COMPLETED | Gastric Cancer; Esophagogastric Junction Disorder |
Hutchison Medipharma Limited |
2021-07-27 | PHASE2 |
| NCT05043090 | ACTIVE_NOT_RECRUITING | Papillary Renal Cell Carcinoma |
AstraZeneca |
2021-10-28 | PHASE3 |
| NCT05015608 | COMPLETED | Non-small Cell Lung Cancer |
Hutchison Medipharma Limited |
2021-11-22 | PHASE3 |
| NCT03944772 | ACTIVE_NOT_RECRUITING | Non-Small Cell Lung Cancer |
AstraZeneca |
2019-06-25 | PHASE2 |
| NCT04923945 | COMPLETED | Non-small Cell Lung Cancer Metastatic |
Hutchison Medipharma Limited |
2021-08-19 | PHASE3 |
| NCT03385655 | ACTIVE_NOT_RECRUITING | Prostate Cancer |
Canadian Cancer Trials Group |
2018-08-01 | PHASE2 |
| NCT03833440 | UNKNOWN | Non-small Cell Lung Cancer |
Assistance Publique Hopitaux De Marseille |
2019-10-08 | PHASE2 |
| NCT03778229 | ACTIVE_NOT_RECRUITING | Carcinoma |
AstraZeneca |
2019-01-09 | PHASE2 |
| NCT02819596 | COMPLETED | Renal Clear Cell Carcinoma; Renal Papillary Cell Carcinoma |
Queen Mary University of London |
2016-05-03 | PHASE2 |
| NCT06348355 | COMPLETED | Healthy Volunteers |
AstraZeneca |
2024-04-12 | PHASE1 |
| NCT05163249 | UNKNOWN | Carcinoma, Non-Small-Cell Lung |
Guangdong Association of Clinical Trials |
2022-05-31 | PHASE2 |
| NCT02761057 | COMPLETED | Locally Advanced Papillary Renal Cell Carcinoma; Metastatic Papillary Renal Cell Carcinoma; Stage III Renal Cell Cancer AJCC v7; Stage IV Renal Cell Cancer AJCC v7; Type 1 Papillary Renal Cell Carcinoma; Type 2 Papillary Renal Cell Carcinoma; Unresectable Renal Cell Carcinoma |
National Cancer Institute (NCI) |
2016-07-25 | PHASE2 |
| NCT05888207 | COMPLETED | Healthy Male Subjects |
AstraZeneca |
2023-06-02 | PHASE1 |
| NCT05768360 | COMPLETED | Healthy Male Subjects |
AstraZeneca |
2023-04-25 | PHASE1 |
| NCT05888207 | Completed | Healthy Male Subjects |
AstraZeneca|Parexel |
2023-06-02 | Phase 1 |
| NCT04606771 | ACTIVE_NOT_RECRUITING | Non-Small Cell Lung Cancer |
AstraZeneca |
2020-09-28 | PHASE2 |
| NCT02897479 | UNKNOWN | Lung Sarcomatoid Carcinoma |
Hutchison Medipharma Limited |
2016-12 | PHASE2 |
| NCT05043090 | Recruiting | Papillary Renal Cell Carcinoma |
AstraZeneca |
2021-10-28 | Phase 3 |
| NCT03592641 | TERMINATED | Colorectal Carcinoma; Metastatic Colon Adenocarcinoma; Metastatic Rectal Adenocarcinoma; Stage III Colon Cancer AJCC v8; Stage III Rectal Cancer AJCC v8; Stage IIIA Colon Cancer AJCC v8; Stage IIIA Rectal Cancer AJCC v8; Stage IIIB Colon Cancer AJCC v8; Stage IIIB Rectal Cancer AJCC v8; Stage IIIC Colon Cancer AJCC v8; Stage IIIC Rectal Cancer AJCC v8; Stage IV Colon Cancer AJCC v8; Stage IV Rectal Cancer AJCC v8; Stage IVA Colon Cancer AJCC v8; Stage IVA Rectal Cancer AJCC v8; Stage IVB Colon Cancer AJCC v8; Stage IVB Rectal Cancer AJCC v8; Stage IVC Colon Cancer AJCC v8; Stage IVC Rectal Cancer AJCC v8; Unresectable Colon Adenocarcinoma; Unresectable Rectal Adenocarcinoma |
National Cancer Institute (NCI) |
2019-07-25 | PHASE2 |
| NCT04675021 | COMPLETED | Cancer |
AstraZeneca |
2020-11-13 | PHASE1 |
| NCT02449551 | COMPLETED | Advanced Gastric Adenocarcinoma |
Samsung Medical Center |
2016-02-10 | PHASE2 |
| NCT04606771 | Active not recruiting | Non-Small Cell Lung Cancer |
AstraZeneca |
2020-09-28 | Phase 2 |
| NCT02447406 | COMPLETED | Advanced Gastric Adenocarcinoma |
Samsung Medical Center |
2015-04-30 | PHASE1; PHASE2 |
| NCT04179071 | COMPLETED | Solid Tumours |
AstraZeneca |
2019-12-13 | PHASE1 |
| NCT04187456 | COMPLETED | Solid Tumors |
AstraZeneca |
2019-12-27 | PHASE1 |
| NCT02143466 | ACTIVE_NOT_RECRUITING | Advanced Non Small Cell Lung Cancer |
AstraZeneca |
2014-08-05 | PHASE1 |
| NCT04118842 | COMPLETED | Solid Tumors |
AstraZeneca |
2019-10-17 | PHASE1 |
| NCT04121910 | COMPLETED | Solid Tumour |
AstraZeneca |
2019-11-07 | PHASE1 |
| NCT03091192 | ACTIVE_NOT_RECRUITING | Carcinoma; Carcinoma, Renal Cell; Kidney Neoplasms; Urologic Neoplasms; Kidney Diseases; Neoplasms by Site; Enzyme Inhibitors; Protein Kinase Inhibitors |
AstraZeneca |
2017-07-25 | PHASE3 |
| NCT03860948 | COMPLETED | Bioequivalence |
Hutchison Medipharma Limited |
2019-04-16 | PHASE1 |
| NCT02447380 | COMPLETED | Advanced Gastric Adenocarcinoma |
Samsung Medical Center |
2017-07-10 | PHASE2 |
| NCT02117167 | COMPLETED | Non-small Cell Lung Cancer Metastatic |
UNICANCER |
2014-04-23 | PHASE2 |
| NCT03258515 | COMPLETED | Solid Tumors |
AstraZeneca |
2017-09-06 | PHASE1 |
| NCT02630420 | WITHDRAWN | Colorectal Cancer |
Yale University |
2017-01 | PHASE1 |
| NCT02127710 | COMPLETED | Papillary Renal Cell Cancer |
AstraZeneca |
2014-04-30 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-07-06)
Check the
Savolitinib (AZD6094)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
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>).
- Savolitinib (AZD6094) Solubility in DMSO
- Savolitinib (AZD6094) Stock Solution
- Savolitinib (AZD6094) Storage
- Savolitinib (AZD6094) Stability
- Savolitinib (AZD6094) Molecular Weight
- Savolitinib (AZD6094) SMILES
- Savolitinib (AZD6094) CAS Number
- Savolitinib (AZD6094) Chemical Structure (2D and 3D)
- Savolitinib (AZD6094) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.