Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Sitravatinib Malate, MGCD516
Sitravatinib · 3 trials · 4 indications
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0), including relevant physical examination, electrocardiograms, and laboratory assessments. Safety analysis set is presented by dose, as prespecified in the statistical analysis plan (SAP).
ORR is defined as the percentage of participants whose best overall response (BOR) is the confirmed complete response (CR) or partial response (PR) assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Efficacy evaluable analysis set is presented by indication group, as prespecified in the statistical analysis plan.
Number of participants with treatment-emergent AEs (TEAEs) and serious adverse events (SAEs), which includes laboratory tests, physical exams, electrocardiogram results and vital signs; TEAE was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study drug(s) up to 30 days following last dose of study drug(s) or initiation of a new anticancer therapy, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Dosing Sequence 1: Sitravatinib Free Base then Malate Salt | EXPERIMENTAL | Sitravatinib free base capsule 120 mg on Day 1 in Period 1 then sitravatinib malate salt capsule 100 mg on Day 1 in Period 2, with a minimum washout period between dose administrations of 14 days |
| Dosing Sequence 2: Sitravatinib Malate Salt then Free Base | EXPERIMENTAL | Sitravatinib malate salt capsule 100 mg on Day 1 in Period 1 then sitravatinib free base capsule 120 mg on Day 1 in Period 2, with a minimum washout period between dose administrations of 14 days |
| Sitravatinib Monotherapy: 80 mg | EXPERIMENTAL | Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer |
| Sitravatinib Monotherapy: 120 mg | EXPERIMENTAL | Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer |
| Sitravatinib 80 mg + Tislelizumab | EXPERIMENTAL | Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer |
| Sitravatinib 120 mg + Tislelizumab | EXPERIMENTAL | Sitravatinib 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer |
| Sitravatinib + Tislelizumab | EXPERIMENTAL | Sitravatinib 120 mg was administered orally once daily in combination with tislelizumab 200 mg intravenously (IV) once every 3 weeks |
| Name | Type | Description |
|---|---|---|
| Sitravatinib | DRUG | Administered orally as a free base capsule |
| Tislelizumab | DRUG | Administered intravenously |
Key Inclusion Criteria: 1. Body mass index between 18.0 and 32.0 kg/m2, inclusive. 2. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at Screening and/or Check-in a...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Sitravatinib is an investigational small molecule kinase inhibitor being developed by BeOne Medicines Ltd. (ticker ONC) for oncology indications. It has been studied in advanced solid tumors, hepatocellular carcinoma, and gastric or gastroesophageal junction cancer. It is not approved and remains in clinical development.
Sitravatinib has been studied in adults with advanced solid tumors, unresectable locally advanced or metastatic hepatocellular carcinoma, and gastric or gastroesophageal junction cancer. It has also been tested in healthy adult male volunteers for capsule formulation bioavailability. All studied indications remain investigational.
Sitravatinib is a small molecule kinase inhibitor, belonging to the -tinib target class. It is designed to inhibit kinase activity. It has been evaluated both as monotherapy and in combination with tislelizumab in clinical studies.
Sitravatinib is being developed by BeOne Medicines Ltd., which trades under the ticker ONC. The company has sponsored Phase 1 studies of the drug in Australia and China.
Sitravatinib is in Phase 1 clinical development. It is investigational and has not been approved for any indication. The completed Phase 1 trials include a bioavailability study in healthy volunteers and studies in advanced solid tumors and hepatocellular or gastric cancer.
Sitravatinib has been evaluated in completed Phase 1 trials including NCT04472650, a bioavailability study of two capsule formulations in healthy adults; NCT03941873, a monotherapy and tislelizumab combination study in hepatocellular and gastric or gastroesophageal junction cancer; and NCT03666143, a combination study with tislelizumab in advanced solid tumors.
Yes, Sitravatinib Malate is an alternative name for Sitravatinib. The malate refers to the salt form of the same active small molecule kinase inhibitor developed by BeOne Medicines Ltd. for oncology indications.