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Closed (no longer recruiting)Last updated: 6 February 2024

TIGIT: This phase 1 trial is examining the safety and effectiveness of two targeted therapies (BGB-A1217 and Tislelizumab) for the treatment of advanced solid tumoursPhase 1/1b Study Investigating Safety, Tolerability, PK and Antitumor Activity of Anti-TIGIT Monoclonal Antibody BGB-A1217 in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors

Clinical summary

Summary

Patients eligible to participate in this trial will receive a specified dose of BGB-A1217 in combination with a fixed dose of tislelizumab.

Conditions

This trial is treating patients with advanced solid tumours.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

TIGIT

More information

Trial Identifiers

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

Trial sponsor

BeiGene Australia Pty Ltd

Scientific Title

Phase 1/1b Study Investigating Safety, Tolerability, PK and Antitumor Activity of Anti-TIGIT Monoclonal Antibody BGB-A1217 in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors

Eligibility

Inclusion

Phase 1 Key Inclusion Criteria

  1. Has Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
  2. ≥ 1 measurable lesion per RECIST v1.1.
  3. Has adequate organ function.
  4. phase 1- Patients 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 1b Key Inclusion Criteria

  1. Signed informed consent form (ICF) and able to comply with study requirements.
  2. Age ≥ 18 years (or the legal age of consent) at the time the ICF is signed.
  3. Histologically or cytologically confirmed tumor types in the following disease cohorts:

    Cohort 1: stage IV squamous NSCLC Cohort 2: stage IV non-squamous NSCLC Cohort 3: stage IV squamous or non-squamous NSCLC with PD-L1 positive. Cohort 4: extensive-stage SCLC Cohort 5: stage IIIB, IIIC or IV NSCLC Cohort 6: stage IV ESCC Cohort 7: stage IV EAC Cohort 8: recurrent or metastatic HNSCC incurable by local therapies Cohort 9: stage IV G/GEJ adenocarcinoma. Cohort 10: stage IV squamous or non-squamous NSCLC with PD-L1 positive.

  4. ECOG Performance Status ≤ 1
  5. Adequate organ function
  6. Willing to use highly effective method of birth control

Exclusion

Phase 1 Key Exclusion Criteria:

  1. Active brain or leptomeningeal metastasis.
  2. Active autoimmune diseases or history of autoimmune diseases that may relapse.
  3. With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc. (antiviral therapy is permitted for patients with hepatocellular carcinoma).
  4. Concurrent participation in another therapeutic clinical trial.
  5. Received prior therapies targeting TIGIT.

Phase 1b Key Exclusion Criteria:

  1. Patients with any prior therapy for recurrent/metastatic disease.
  2. Non-squamous NSCLC patients with sensitizing epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) fusion, and c-ros oncogene 1 (ROS1) fusion.
  3. Gastric cancer patients with squamous or with positive HER2 expression.
  4. Prior therapy with any drug specifically targeting T-cell co-stimulation or checkpoint pathways. (anti-PD(L)1 exception for Cohort 5).
  5. Active leptomeningeal disease or uncontrolled brain metastasis.
  6. Active autoimmune diseases or history of autoimmune diseases that may relapse.
  7. With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc. (antiviral therapy is permitted for patients with hepatocellular carcinoma).
  8. Concurrent participation in another therapeutic clinical study.

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

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • 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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