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RecruitingLast updated: 6 February 2024

BGB-290-AU-102: This phase I/II trial is evaluating the safety and recommended dose of a combined targeted therapy (BGB-A425 and Tislelizumab) in patients with advanced solid cancersPhase 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

Clinical summary

Summary

This trial has three parts; dose escalation (phase I), dose expansion (phase II) and a China sub-study.

Conditions

This trial is treating patients with advanced solid cancers

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I/II

Trial Acronym

BGB-290-AU-102

More information

Trial Identifiers

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

Trial sponsor

BeiGene Australia Pty Ltd

Scientific Title

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

Eligibility

Inclusion

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

  • Adequate organ function
  • 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

  • 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, noninfectious 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

Inclusion

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

Exclusion

  • You have certain types of non-cancer medical conditions.
  • 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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