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Study of BGB-A425 and LBL-007 in Combination With Tislelizumab in Advanced Solid Tumors
EU CTIS ID: 2022-500694-14-00
What this study is testing
Phase 1 (Dose Escalation): To assess the safety and tolerability of BGB-A425 in combination with tislelizumab in patients with advanced solid tumors To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended Phase 2 dose (RP2D) of BGB-A425 in combination with tislelizumab Phase 2 (Safety Lead-in): To assess the safety and tolerability of BGB-A425 in combination with LBL-007 and tislelizumab or LBL-007 in combination with tislelizumab in patients with advanced solid tumors To determine the MTD or MAD and RP2D/ recommended dose for expansion of LBL-007 in combination with BGB-A425 and tislelizumab, and LBL-007 in combination with tislelizumab Phase 2 (Dose Expansion): To evaluate antitumor activity based on objective response rate (ORR) of various combinations of BGB-A425 and LBL-007 with tislelizumab in selected tumor types
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 or not tolerated
- 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.
You likely can't join if
- NSCLC patients with known EGFR mutation, BRAF mutation, ALK fusion, or ROS1 fusion
- 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
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
See the full eligibility criteria
- 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 or not tolerated
- 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.
- NSCLC patients with known EGFR mutation, BRAF mutation, ALK fusion, or ROS1 fusion
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United States
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United States; Korea, Republic of. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.