Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03941873 | A Study to Investigate Sitravatinib as Monotherapy and in Combination With Tislelizumab in Participants With Unresectable Locally Advanced or Metastatic Hepatocellular Carcinoma or Gastric/Gastroesophageal Junction Cancer | PHASE1 | COMPLETED | 111 | — | — | Feb 28, 2019 | Mar 31, 2023 | Oct 26, 2024 | 18 | China |
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
| Name | Type | Description |
|---|---|---|
| Sitravatinib | DRUG | Administered orally as a capsule |
| Tislelizumab | DRUG | Administered intravenously |
Key Inclusion Criteria: * Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic HCC/gastric cancer/GEJ cancer * Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments * Age...