{
    "info": {
        "nct_id": "NCT05294731",
        "official_title": "A Phase 1/2, Open-Label, Dose-Escalation and Expansion Study of the Bruton Tyrosine Kinase-Targeted Protein-Degrader BGB-16673 in Chinese Patients With B-Cell Malignancies",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Key Inclusion Criteria\n\n1. Provision of signed and dated written informed consent prior to any study\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2\n3. Adequate organ function of coagulation function, liver function, renal function and pancreatic function and measure disease per disease-specific response criteria\n4. Phase 1: Confirmed diagnosis of R/R Marginal Zone Lymphoma (MZL), Follicular Lymphoma (grade 1-3a), Waldenström Macroglobulinemia (WM), non-germinal center B-cell (non-GCB) diffuse large B-cell lymphoma (DLBCL), Richter's transformation to DLBCL, MCL, or CLL/SLL\n5. Phase 2: Confirmed diagnosis of MCL, or CLL/SLL\n6. Highly effective method of birth control during study treatment period, and for at least 90 days after the last dose of the study drug\n\nKey Exclusion Criteria\n\n1. Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer\n2. Require ongoing systemic treatment for any other malignancy or systemic corticosteroid treatment\n3. Receiving treatment with a strong CYP3A inhibitor or inducer ≤ 14 days before the first dose of BGB-16673, or proton-pump inhibitors ≤ 5 days before the first dose of BGB-16673.\n4. Current or history of central nervous involvement\n5. Prior autologous stem cell transplant unless ≥ 3 months after transplant, prior chimeric cell therapy unless ≥ 6 months after cell infusion, prior allogeneic stem cell transplant ≤ 6 months before the first dose of the study drug\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply"
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "1. Provision of signed and dated written informed consent prior to any study",
            "criterions": [
                {
                    "exact_snippets": "Provision of signed and dated written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Adequate organ function of coagulation function, liver function, renal function and pancreatic function and measure disease per disease-specific response criteria",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function of coagulation function",
                    "criterion": "coagulation function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate organ function of ... liver function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate organ function of ... renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate organ function of ... pancreatic function",
                    "criterion": "pancreatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "measure disease per disease-specific response criteria",
                    "criterion": "disease measurement",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "disease-specific response criteria"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Phase 1: Confirmed diagnosis of R/R Marginal Zone Lymphoma (MZL), Follicular Lymphoma (grade 1-3a), Waldenström Macroglobulinemia (WM), non-germinal center B-cell (non-GCB) diffuse large B-cell lymphoma (DLBCL), Richter's transformation to DLBCL, MCL, or CLL/SLL",
            "criterions": [
                {
                    "exact_snippets": "Confirmed diagnosis of R/R Marginal Zone Lymphoma (MZL)",
                    "criterion": "R/R Marginal Zone Lymphoma (MZL)",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Confirmed diagnosis of ... Follicular Lymphoma (grade 1-3a)",
                    "criterion": "Follicular Lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": ""
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": ""
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Confirmed diagnosis of ... Waldenström Macroglobulinemia (WM)",
                    "criterion": "Waldenström Macroglobulinemia (WM)",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Confirmed diagnosis of ... non-germinal center B-cell (non-GCB) diffuse large B-cell lymphoma (DLBCL)",
                    "criterion": "non-germinal center B-cell (non-GCB) diffuse large B-cell lymphoma (DLBCL)",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Confirmed diagnosis of ... Richter's transformation to DLBCL",
                    "criterion": "Richter's transformation to DLBCL",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Confirmed diagnosis of ... MCL",
                    "criterion": "MCL",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Confirmed diagnosis of ... CLL/SLL",
                    "criterion": "CLL/SLL",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Phase 2: Confirmed diagnosis of MCL, or CLL/SLL",
            "criterions": [
                {
                    "exact_snippets": "Confirmed diagnosis of MCL",
                    "criterion": "MCL diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Confirmed diagnosis of ... CLL/SLL",
                    "criterion": "CLL/SLL diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Highly effective method of birth control during study treatment period, and for at least 90 days after the last dose of the study drug",
            "criterions": [
                {
                    "exact_snippets": "Highly effective method of birth control during study treatment period, and for at least 90 days after the last dose of the study drug",
                    "criterion": "birth control",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "highly effective"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "during study treatment period, and for at least 90 days after the last dose of the study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "Prior malignancy (other than the disease under study) within the past 2 years",
                    "criterion": "prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "basal skin cancer",
                                "squamous skin cancer",
                                "superficial bladder cancer",
                                "carcinoma in situ of the cervix",
                                "carcinoma in situ of the breast",
                                "localized Gleason score ≤ 6 prostate cancer"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Require ongoing systemic treatment for any other malignancy or systemic corticosteroid treatment",
            "criterions": [
                {
                    "exact_snippets": "ongoing systemic treatment for any other malignancy",
                    "criterion": "systemic treatment for other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "ongoing"
                        }
                    ]
                },
                {
                    "exact_snippets": "systemic corticosteroid treatment",
                    "criterion": "systemic corticosteroid treatment",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "ongoing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Receiving treatment with a strong CYP3A inhibitor or inducer ≤ 14 days before the first dose of BGB-16673, or proton-pump inhibitors ≤ 5 days before the first dose of BGB-16673.",
            "criterions": [
                {
                    "exact_snippets": "Receiving treatment with a strong CYP3A inhibitor or inducer ≤ 14 days before the first dose of BGB-16673",
                    "criterion": "treatment with a strong CYP3A inhibitor or inducer",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Receiving treatment with ... proton-pump inhibitors ≤ 5 days before the first dose of BGB-16673",
                    "criterion": "treatment with proton-pump inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Current or history of central nervous involvement",
            "criterions": [
                {
                    "exact_snippets": "Current or history of central nervous involvement",
                    "criterion": "central nervous involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Prior autologous stem cell transplant unless ≥ 3 months after transplant, prior chimeric cell therapy unless ≥ 6 months after cell infusion, prior allogeneic stem cell transplant ≤ 6 months before the first dose of the study drug",
            "criterions": [
                {
                    "exact_snippets": "Prior autologous stem cell transplant unless ≥ 3 months after transplant",
                    "criterion": "prior autologous stem cell transplant",
                    "requirements": [
                        {
                            "requirement_type": "time since transplant",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "prior chimeric cell therapy unless ≥ 6 months after cell infusion",
                    "criterion": "prior chimeric cell therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since cell infusion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "prior allogeneic stem cell transplant ≤ 6 months before the first dose of the study drug",
                    "criterion": "prior allogeneic stem cell transplant",
                    "requirements": [
                        {
                            "requirement_type": "time since transplant",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Note: Other protocol defined Inclusion/Exclusion criteria may apply",
            "criterions": [
                {
                    "exact_snippets": "Other protocol defined Inclusion/Exclusion criteria",
                    "criterion": "protocol defined criteria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Key Inclusion Criteria",
            "criterions": []
        },
        {
            "line": "Key Exclusion Criteria",
            "criterions": []
        }
    ]
}