Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Sitravatinib is an investigational small molecule being studied for the treatment of advanced solid tumors, hepatocellular carcinoma, and gastric or gastroesophageal junction cancer. It is being evaluated as a monotherapy and in combination with tislelizumab in clinical trials.
Sitravatinib is being developed by BeOne Medicines Ltd., which trades under the ticker ONC. The company is conducting clinical trials to assess the drug's safety and efficacy in oncology indications.
Sitravatinib is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All completed trials for Sitravatinib are Phase 1 studies.
Sitravatinib has been studied in three completed Phase 1 trials. NCT03666143 assessed Sitravatinib in combination with tislelizumab in advanced solid tumors. NCT03941873 evaluated Sitravatinib as monotherapy and in combination with tislelizumab in hepatocellular carcinoma and gastric or gastroesophageal junction cancer. NCT04472650 examined the bioavailability of two capsule formulations.
No, Sitravatinib is not the same as tislelizumab. Sitravatinib is a small molecule being studied as a monotherapy and in combination with tislelizumab, which is a separate drug. The two are being tested together in clinical trials for advanced solid tumors and other cancers.