2024-02-13T00:00:00.000+11:00
Ongoing

BGB-900-102

BGB-900-102
Solid tumours

Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-TIM-3 Monoclonal Antibody BGB-A425 in Combination with Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients with Advanced Solid Tumors.

Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-TIM-3 Monoclonal Antibody BGB-A425 in Combination with Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients with Advanced Solid Tumors.

Trial overview

Topic

Solid tumors

Eligibility criteria

Inclusion criteria:

  • Adequate organ function
  • ECOG =
  • Phase 1 Dose Escalation + Phase 2 Safety Lead-In: Participants with histologically or cytologically confirmed advanced, metastatic, unresectable solid tumors who have previously received standard systemic therapy or for which treatment is not available, not tolerated or refused.
  • Phase 2 Dose-Expansion: Participants with one of the following histologically or cytologically confirmed solid tumors:
  • For HNSCC participants in cohort 1,4 and 6 (PD-L1 positive):
  • Recurrent/metastatic head and neck squamous cell cancer of the oral cavity, oropharynx, hypopharynx, and/or larynx whose tumor is not amenable to local therapy with curative intent (ie, surgery or radiation therapy with or without chemotherapy • For NSCLC participants in Cohort 2, 5 and 7 (PD-L1 positive): Locally recurrent Stage IIIB, stage 
    IIIC or Stage IV squamous or non-squamous non-small cell lung cancer
  • For RCC participants in Cohort 3: Locally advanced unresectable or metastatic and histologically confirmed renal cell carcinoma with a clear cell histology

Exclusion Criteria:

  • NSCLC patients with known EGFR mutation, BRAF mutation, ALK fusion, or ROS1 fusion
  • Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
  • Active autoimmune diseases or history of autoimmune diseases that may relapse.
  • Interstitial lung disease, non-infectious pneumonitis or uncontrolled lung diseases
  • Uncontrolled diabetes or significant cardiac issues
  • Infections requiring systemic antibacterial, antifungal, or antiviral therapy
  • History of severe hypersensitivity reactions to other monoclonal antibodies
  • History of HIV infection or untreated chronic hepatitis B or chronic hepatitis B virus carriers
  • Major surgical procedure within 28 days before study drug administration
  • Chemotherapy, radiotherapy, immunotherapy or any investigational therapies within 28 days (PH 2 Safety Lead-In) or 14 days (PH 2 Dose Expansion) or 5 half-lives of (whichever is shorter) of first administration of study drug(s).
  • With infections (including tuberculosis infection, etc) requiring systemic antibacterial, antifungal, or antiviral therapy = 14 days prior to the first dose of study drug(s), or a requirement for chronic prophylactic treatment with antibiotics.
  • Concurrent participation in another therapeutic clinical trial
  • Received prior therapies targeting TIM-3and/or LAG3
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study details

This is an open-label, multicenter, nonrandomized Phase 1 and 2 clinical trial evaluating various combinations of BGB-A425 and/or LBL-007 with tislelizumab.

Further information

Please click here for more information

Location

Cabrini Research - Malvern

Cabrini Research - Malvern :::

Calvary North -  Adelaide

Calvary North -  Adelaide :::

Thank you for submitting.

We will be in touch within 24 hours

An unexpected error has occurred.

You will need to complete the form again, sorry for the inconvenience.

How can we help?

If you have a medical emergency please call 000. If you have an urgent request and would like to speak to our staff, please contact one of our centres directly.

* Indicates a required field.