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Active (not recruiting) Phase 1 NCT04649385

BGB-15025 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Participants With Advanced Solid Tumors

Phase 1 – testing safety in a small group of people
Conditions: Advanced Solid Tumor

Sponsor: BeiGene

trial.available_in: БГ
Overview
The primary objective of this study is to assess the safety and tolerability of BGB-15025 alone and in combination with tislelizumab; and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended Phase 2 doses (RP2D) of BGB-15025 alone and in combination with tislelizumab in participants with advanced solid tumors.
Who can participate
Key Inclusion Criteria: 1. Phase 1a (dose escalation): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available, not tolerated or refused, and who have not received prior therapy targeting HPK1 2. Phase 1b (dose expansion): Participant with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors, including non-small cell lung cancer, esophageal cancer or gastric/Gastroesophageal junction cancer (other solid tumors may be included) who have progressed following systemic anticancer therapies or have no prior systemic treatment for advanced disease 3. At least 1 measurable lesion as defined per RECIST 1.1. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 5. Adequate organ function as indicated by the following laboratory values up to first dose of study treatment: Hemoglobin≥ 90 g/L, Absolute neutrophil count ≥ 1.5 x 109/L , Serum total bilirubin ≤ 1.5 x ULN (\< 3 x ULN for participants with Gilbert syndrome ), AST and ALT≤ 2.5 x ULN Key Exclusion Criteria: 1. Active leptomeningeal disease or uncontrolled and untreated brain metastasis. 2. Active autoimmune diseases or history of autoimmune diseases that may relapse 3. Any active malignancy ≤ 2 years before the first dose of study treatment except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent 4. Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study treatment 5. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including but not limited to pulmonary fibrosis, acute lung diseases, etc. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations 5
Australia (1)
Prince of Wales Hospital
Randwick , New South Wales
China (1)
Harbin Medical University Cancer Hospital
Harbin , Heilongjiang
New Zealand (1)
Auckland City Hospital
Auckland
South Korea (1)
Seoul National University Bundang Hospital
Seongnam-si , Gyeonggi-do
United States (1)
Icahn School of Medicine At Mount Sinai
New York , New York
Technical details
Status
Active (not recruiting)
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
04.03.2021
Completion date
16.05.2026
Registry ID
NCT04649385
Source
anzctr
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