Description:
This is an open-label, multicenter, non-randomized Phase 1b clinical trial for patients with
histologically or cytologically confirmed locally advanced or metastatic tumors including
non-squamous or squamous NSCLC, RCC, OC, or melanoma.
Title
- Brief Title: A Phase 1b Study to Assess Sitravatinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors.
- Official Title: A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
BGB-900-103
- SECONDARY ID:
CTR20181404
- NCT ID:
NCT03666143
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Sitravatinib | Tislelizumab | Anti-PD-1/PD-L1 antibody R/R melanoma |
Purpose
This is an open-label, multicenter, non-randomized Phase 1b clinical trial for patients with
histologically or cytologically confirmed locally advanced or metastatic tumors including
non-squamous or squamous NSCLC, RCC, OC, or melanoma.
Detailed Description
All patients will receive sitravatinib 120 mg orally once daily in combination with
tislelizumab 200 mg IV once every 3 weeks until occurrence of PD, unacceptable toxicity,
death, withdrawal of consent, or study termination by sponsor.
There will be 9 cohorts in the study. Approximately 20 patients will be enrolled into each
cohort. The patients will be enrolled according to their tumor type and prior anti-programmed
cell death protein-1 (PD-1)/PD-L1 antibody treatment.
- Cohort A: Anti-PD-1/PD-L1 antibody refractory/resistant metastatic, non-squamous NSCLC
- Cohort B: Anti-PD-1/PD-L1 antibody naïve metastatic, non-squamous NSCLC
- Cohort C: Anti-PD-1/PD-L1 antibody refractory/resistant metastatic or advanced RCC
- Cohort D (China-only): Metastatic or advanced RCC without prior systemic therapy
- Cohort E: Anti-PD-1/PD-L1 antibody naïve recurrent and platinum resistant epithelial OC
- Cohort F: Anti-PD-1/PD-L1 antibody treated metastatic, squamous NSCLC • Cohort G:
Anti-PD-1/PD-L1 antibody refractory/resistant unresectable or metastatic melanoma
- Cohort H: PD-L1 positive, aive, advanced or metastatic, non-squamous NSCLC
- Cohort I: PD-L1 positive,naive, advanced or metastatic, squamous NSCLC
Trial Arms
Name | Type | Description | Interventions |
---|
Anti-PD-1/PD-L1 antibody refractory/resistant NSCLC | Experimental | | |
Anti-PD-1/PD-L1 antibody naïve NSCLC | Experimental | | |
Anti-PD-1/PD-L1 antibody refractory/resistant RCC | Experimental | | |
Metastatic or advanced RCC without prior systemic therapy | Experimental | | |
Anti-PD-1/PD-L1 naïve recurrent / platinum resistant OC | Experimental | | |
Anti-PD-1/PD-L1 treated metastatic, squamous NSCLC | Experimental | | |
Anti-PD-1/PD-L1 antibody R/R melanoma | Experimental | | |
PD-L1 positive, naïve, advanced or metastatic, non-sq NSCLC | Experimental | | |
PD-L1 positive, naïve, advanced or metastatic, sq NSCLC | Experimental | | |
Eligibility Criteria
Inclusion Criteria:
1. Able to provide written informed consent and can understand and agree to comply with
the requirements of the study and the Schedule of Assessments
2. 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)
3. At least 1 measurable lesion as defined by RECIST v1.1
4. Provide archival tumor tissue (formalin-fixed paraffin-embedded block [FFPE] with
tumor tissue or unstained slides), if available.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
6. Adequate hematologic and end-organ function
7. Patients with inactive/asymptomatic carrier, chronic, or active hepatitis B virus
(HBV) must have HBV deoxyribonucleic acid (DNA) < 500 IU/mL (or 2500 copies/mL) at
Screening
8. Females of childbearing potential must be willing to use a highly effective method of
birth control for the duration of the study, and ≥ 120 days after the last dose of
study drugs and have a negative serum pregnancy test ≤ 7 days of first dose of study
drugs
9. Non-sterile males must be willing to use a highly effective method of birth control
for the duration of the study and for ≥ 120 days after the last dose of study drugs
Exclusion Criteria:
1. Unacceptable toxicity on prior anti-PD-1/PD-L1 treatment.
2. Active leptomeningeal disease or uncontrolled brain metastasis.
3. Active autoimmune diseases or history of autoimmune diseases that may relapse.
4. Any active malignancy ≤ 2 years
5. Any condition that required systemic treatment with either corticosteroids (> 10 mg
daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days
before first dose of study drugs
6. History of interstitial lung disease, noninfectious pneumonitis or uncontrolled
diseases, including pulmonary fibrosis, acute lung diseases, etc.
8. 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
9. Known history of HIV infection
10. Patients with active hepatitis C infection.
11. Any major surgical procedure requiring general anesthesia ≤ 28 days before first dose
of study drugs
12. Prior allogeneic stem cell transplantation or organ transplantation
13. Hypersensitivity to tislelizumab or sitravatinib, to any ingredient in the formulation,
or to any component of the container
14. Bleeding or thrombotic disorders or use of anticoagulants such as warfarin or similar
agents requiring therapeutic INR monitoring within 6 months before first dose of study
drugs
15. Concurrent participation in another therapeutic clinical trial
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of participants with adverse events (AEs) and serious adverse events (SAEs) per NCI-CTCAE version 5.0 |
Time Frame: | All AEs and SAEs will be reported until either 30 days after last dose of study drug(s) or initiation of new anticancer therapy, whichever occurs first. Immune-related should be reported until 90 days after the last dose of tislelizumab |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | BeiGene |
Last Updated
July 19, 2021