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Closed (no longer recruiting)Last updated: 1 February 2024

BGB-900-103: This phase I trial is combining an oral drug (sitravatinib) with an immuno-oncology drug (Tislelizumab) for the treatment of patients with locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC), Renal Cell Carcinoma (RCC) or Ovarian Cancer (OC)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 summary

Summary

This is a non-randomised trial, in which patients will be allocated to one of five cohorts according to their tumor type and prior anti-programmed cell death protein-1 (PD-1)/PD-L1 antibody treatment. Cohort allocation is as described. Cohort A: Patients with anti-PD-1/PD-L1 antibody refractory/resistant metastatic, non-squamous NSCLC Cohort B: Patients with anti-PD-1/PD-L1 antibody naïve metastatic, non-squamous NSCLC. Cohort C: Patients with anti-PD-1/PD-L1 antibody refractory/resistant metastatic or advanced RCC. Cohort D (China-only): Patients with metastatic or advanced RCC without prior systemic therapy. Cohort E: Patients with anti-PD-1/PD-L1 antibody naïve recurrent and platinum resistant Epithelial OC.All cohorts will receive sitravatinib 120 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks.

Conditions

This trial is treating patients with Non-small Cell Lung Cancer (NSCLC), Renal Cell Carcinoma or Ovarian Cancer.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

BGB-900-103

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

BeiGene Australia Pty Ltd

Scientific 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

Eligibility

Inclusion

  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

  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

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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