For Healthcare Professionals

Study of BGB-A425 and LBL-007 in Combination With Tislelizumab in Advanced Solid Tumors

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Key Inclusion Criteria:

Has Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.

  1. Adequate organ function
  2. 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.
  3. Phase 2 Dose-Expansion: Participants with one of the following histologically or cytologically confirmed solid tumors:
  4. 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

Key Exclusion Criteria:

  1. NSCLC patients with known EGFR mutation, BRAF mutation, ALK fusion, or ROS1 fusion
  2. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
  3. Active autoimmune diseases or history of autoimmune diseases that may relapse.
  4. Interstitial lung disease, noninfectious pneumonitis or uncontrolled lung diseases
  5. Uncontrolled diabetes or significant cardiac issues
  6. Infections requiring systemic antibacterial, antifungal, or antiviral therapy
  7. History of severe hypersensitivity reactions to other monoclonal antibodies
  8. History of HIV infection or untreated chronic hepatitis B or chronic hepatitis B virus carriers
  9. Major surgical procedure within 28 days before study drug administration
  10. 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).
  11. 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.
  12. Concurrent participation in another therapeutic clinical trial
  13. Received prior therapies targeting TIM-3and/or LAG3

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1 (877) 828-5568Email iconEmail Study Center

Study Details


Contition

Locally Advanced or Metastatic Solid Tumors for Phase 1,Dose Escalation and Phase 2 Safety Lead-in, HNSCC, NSCLC and RCC Participants for Phase 2

Age

18+

Phase

PHASE1/PHASE2

Participants Needed

358

Est. Completion Date

Dec 29, 2027

Treatment Type

INTERVENTIONAL


Sponsor

BeiGene

ClinicalTrials.gov NCT Identifier

NCT03744468

Study Number

BGB-900-102

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