Phase 1-2 Study Investigating Safety, Tolerability, how the drug will be accepted in the body with treatment of BGB-A333 Alone and in Combination with Tislelizumab in Patients with Malignant Tumors
- Conditions
- Anti-PD-L1 Monoclonal Antibody BGB-A333 Alone and in Combination with Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients with Advanced Solid TumorsMedDRA version: 20.1Level: LLTClassification code 10065143Term: Malignant solid tumourSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-000265-37-ES
- Lead Sponsor
- BeiGene, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 39
1. Able to provide written informed consent and can understand and comply with the requirements of the study
2. Age = 18 years on the day of signing the ICF (or the legal age of consent in the jurisdiction in which the study is taking place)
3. For Phase 1 only: patients with histologically or cytologically confirmed advanced or metastatic, unresectable solid tumors who have progressed during or after standard therapy or for which treatment is not available, not tolerated or refused
4. For Phase 2 only:
a. Arm 1: Patients with locally advanced and metastatic urothelial carcinoma who have progressed during or after treatment with platinum-based chemotherapy or who could not tolerate platinum-based chemotherapy.
b. Sponsor may consider other tumor types including but not limited to NSCLC, RCC, SCCHN, GC, MSI-high cancer, etc. The eligibility criteria for patients with these tumor types will be defined in future protocol amendments
5. Patient must have at least one measurable lesion as defined per RECIST v1.1
Note: The target lesion(s) selected have not been previously treated with local therapy or the target lesion(s) selected that are within the field of prior local therapy have subsequently progressed as defined by RECIST v1.1.
6. Has Eastern Cooperative Oncology Group (ECOG) Performance Status =1
7. Has adequate organ function as indicated by the following laboratory values:
a. Absolute neutrophil count (ANC) = 1.5 × 109/L, platelets = 75 × 109/L, hemoglobin = 90 g/L. Note: Patients must not have required a blood transfusion or growth factor support = 14 days before sample collection
b. Serum creatinine = 1.5 × upper limit of normal (ULN), or estimated GFR = 60 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation (Appendix 7)
c. Aspartate transaminase (AST) and alanine aminotransferase (ALT) = 3 × ULN
d. Serum total bilirubin = 1.5 X ULN (total bilirubin must be < 3 X ULN for patients with Gilberts syndrome)
e. For hepatocellular carcinoma (HCC) patients only, patient must meet the Child-Pugh A classification for liver function as assessed within 7 days before the first dose of study drug(s) (Appendix 11).
8. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and = 120 days after the last dose of study drug (s), and have a negative urine or serum pregnancy test = 7 days of the first dose of study drug(s)
9. Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for = 120 days after the last dose of study drug(s)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 152
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16
1. Active leptomeningeal disease or uncontrolled brain metastasis. Patients with equivocal findings or with confirmed brain metastases are eligible for enrollment provided they are asymptomatic and radiologically stable without the need for corticosteroid treatment for at least 4 weeks prior to the first dose of study drug(s).
2. Active autoimmune diseases or history of autoimmune diseases that may relapse
Note: Patients with the following diseases are not excluded and may proceed to further screening:
a. Controlled type 1 diabetes
b. Hypothyroidism (provided it is managed with hormone replacement therapy only)
c. Controlled celiac disease
d. Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, alopecia)
e. Any other disease that is not expected to recur in the absence of external triggering factors
3. Any active malignancy = 2 years before the first dose of study drug(s), except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)
4. Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication = 14 days before administration of study drug
Note: Patients who are currently or have previously been on any of the following steroid regimens are not excluded:
a. Adrenal replacement steroid (dose = 10 mg daily of prednisone or equivalent)
b. Topical, ocular, intra-articular, intranasal, or inhalational corticosteroid with minimal systemic absorption
c. Short course (= 7 days) of corticosteroid prescribed prophylactically (eg, for contrast dye allergy) or for the treatment of a non-autoimmune condition (eg, delayed-type hypersensitivity reaction caused by contact allergen)
5. With uncontrolled diabetes or > Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management
6. With significant pulmonary disease (ie, chronic obstructive pulmonary disease [COPD], emphysema or chronic bronchitis) or with history of interstitial lung disease, noninfectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.
7. With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc. Note: antiviral therapy is permitted for patients with hepatocellular carcinoma
8. A known history of HIV infection
9. A known history of HBV or HCV infection, except for patients with HCC
19. Received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody (or any other antibody targeting T cell co-stimulation pathways)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method