Clinical Trials /

A Phase 1b Study to Assess Sitravatinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors.

NCT03666143

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.

Related Conditions:
  • Clear Cell Renal Cell Carcinoma
  • Malignant Ovarian Epithelial Tumor
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

  • Advanced Solid Tumors

Interventions

DrugSynonymsArms
SitravatinibTislelizumabAnti-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

NameTypeDescriptionInterventions
Anti-PD-1/PD-L1 antibody refractory/resistant NSCLCExperimental
  • Sitravatinib
Anti-PD-1/PD-L1 antibody naïve NSCLCExperimental
  • Sitravatinib
Anti-PD-1/PD-L1 antibody refractory/resistant RCCExperimental
  • Sitravatinib
Metastatic or advanced RCC without prior systemic therapyExperimental
  • Sitravatinib
Anti-PD-1/PD-L1 naïve recurrent / platinum resistant OCExperimental
  • Sitravatinib
Anti-PD-1/PD-L1 treated metastatic, squamous NSCLCExperimental
  • Sitravatinib
Anti-PD-1/PD-L1 antibody R/R melanomaExperimental
  • Sitravatinib
PD-L1 positive, naïve, advanced or metastatic, non-sq NSCLCExperimental
  • Sitravatinib
PD-L1 positive, naïve, advanced or metastatic, sq NSCLCExperimental
  • Sitravatinib

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:Recruiting
Lead Sponsor:BeiGene

Last Updated

April 24, 2020