Phase 1
Completed N=216
A Phase 1b Study to Assess Sitravatinib in Combination With Tislelizumab in Participants With Advanced Solid Tumors
Source: ClinicalTrials.gov NCT03666143 ↗Enrolled (actual)
216
Serious AEs
55.6%
Results posted
Jun 2024
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) — 216; 120 Participants
Summary
This was an open-label, multicenter, non-randomized Phase 1b clinical trial for participants with histologically or cytologically confirmed locally advanced or metastatic tumors including non-squamous or squamous non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), ovarian cancer (OC), or melanoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
216; 120 | — |
| SECONDARY Objective Response Rate (ORR) |
4.3; 23.8; 66.7; 0.0; 28.8; 18.2 | — |
| SECONDARY Duration of Response (DOR) |
3.1; 17.9; 11.4; 5.6; 6.9; 19.1 | — |
| SECONDARY Disease Control Rate (DCR) |
78.3; 85.7; 100.0; 100.0; 79.7; 90.9 | — |
| SECONDARY Progression-free Survival (PFS) |
4.2; 7.0; 15.9; 2.7; 4.1; 5.3 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) for Sitravatinib |
49.49; 98.36 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) for Sitravatinib |
6.09; 6.08 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Time Point (AUC(0-t)) for Sitravatinib |
414.01; 1539.96 | — |
| SECONDARY Clearance After Oral Administration (CL/F) for Sitravatinib |
72.89; 58.30 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve During the Dosing Interval (AUC(0-tau)) for Sitravatinib |
1050.57; 2058.23 | — |
| SECONDARY Observed Accumulation Ratio (Ro) for AUC0-tau for Sitravatinib |
1.83 | — |
| SECONDARY Observed Accumulation Ratio (Ro) for Cmax for Sitravatinib |
2.23 | — |
Eligibility Criteria
Inclusion Criteria
- 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 ≥ 18 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place)
- At least 1 measurable lesion as defined by RECIST v1.1
- Provide archival tumor tissue (formalin-fixed paraffin-embedded block [FFPE] with tumor tissue or unstained slides), if available.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- Adequate hematologic and end-organ function
- Participants with inactive/asymptomatic carrier, chronic, or active hepatitis B virus (HBV) must have HBV deoxyribonucleic acid (DNA) 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before first dose of study drugs
- History of interstitial lung disease, noninfectious pneumonitis or uncontrolled diseases, including pulmonary fibrosis, acute lung diseases, etc.
- Severe chronic or active infections (including tuberculosis infection, etc.) requiring systemic antibacterial, antifungal or antiviral therapy, within 14 days prior to first dose of study drugs
- Known history of human immunodeficiency virus (HIV) infection
- Participants with active hepatitis C infection
- Any major surgical procedure requiring general anesthesia ≤ 28 days before first dose of study drugs
- Prior allogeneic stem cell transplantation or organ transplantation
- Hypersensitivity to tislelizumab or sitravatinib, to any ingredient in the formulation, or to any component of the container
- Bleeding or thrombotic disorders or use of anticoagulants such as warfarin or similar agents requiring therapeutic international normalized ratio (INR) monitoring within 6 months before first dose of study drugs
- Concurrent participation in another therapeutic clinical trial
Data sourced from ClinicalTrials.gov (NCT03666143). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.