{
    "info": {
        "nct_id": "NCT05884801",
        "official_title": "A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of QLS1103 in Subjects With Advanced Solid Tumors",
        "inclusion_criteria": "* 1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;\n* 2. Aged ≥18 years old;\n* 3. Histologically or cytologically confirmed advanced or recurrent or metastatic solid tumor;\n* 4. Failure of adequate standard treatment, or no effective standard treatment;\n* 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;\n* 6. Life expectancy ≥12 weeks;\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* 1. Subjects received systemic anticancer therapy within 4 weeks prior to the first dose;\n* 2. Subjects received experimental medication or therapy within 4 weeks prior to the first dose;\n* 3. Subjects received major surgery within 4 weeks prior to the first dose;\n* 4. Persistent toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade >1 severity that is related to prior therapy;\n* 5. Cardiovascular and cerebrovascular diseases with clinical significance;\n* 6. Active gastrointestinal disease or other conditions that significantly interfere with drug absorption.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* 1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;",
            "criterions": [
                {
                    "exact_snippets": "Subjects must voluntarily agree to participate in the trial",
                    "criterion": "voluntary agreement to participate",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sign a written informed consent form",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 2. Aged ≥18 years old;",
            "criterions": [
                {
                    "exact_snippets": "Aged ≥18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 3. Histologically or cytologically confirmed advanced or recurrent or metastatic solid tumor;",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed",
                    "criterion": "tumor confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced or recurrent or metastatic solid tumor",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "advanced",
                                "recurrent",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 4. Failure of adequate standard treatment, or no effective standard treatment;",
            "criterions": [
                {
                    "exact_snippets": "Failure of adequate standard treatment",
                    "criterion": "standard treatment",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no effective standard treatment",
                    "criterion": "standard treatment",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 6. Life expectancy ≥12 weeks;",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy ≥12 weeks;",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": [
        {
            "line": "* 1. Subjects received systemic anticancer therapy within 4 weeks prior to the first dose;",
            "criterions": [
                {
                    "exact_snippets": "Subjects received systemic anticancer therapy within 4 weeks prior to the first dose",
                    "criterion": "systemic anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 2. Subjects received experimental medication or therapy within 4 weeks prior to the first dose;",
            "criterions": [
                {
                    "exact_snippets": "Subjects received experimental medication or therapy within 4 weeks prior to the first dose",
                    "criterion": "experimental medication or therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 3. Subjects received major surgery within 4 weeks prior to the first dose;",
            "criterions": [
                {
                    "exact_snippets": "Subjects received major surgery within 4 weeks prior to the first dose",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 5. Cardiovascular and cerebrovascular diseases with clinical significance;",
            "criterions": [
                {
                    "exact_snippets": "Cardiovascular and cerebrovascular diseases with clinical significance",
                    "criterion": "cardiovascular diseases",
                    "requirements": [
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Cardiovascular and cerebrovascular diseases with clinical significance",
                    "criterion": "cerebrovascular diseases",
                    "requirements": [
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 6. Active gastrointestinal disease or other conditions that significantly interfere with drug absorption.",
            "criterions": [
                {
                    "exact_snippets": "Active gastrointestinal disease",
                    "criterion": "gastrointestinal disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other conditions that significantly interfere with drug absorption",
                    "criterion": "conditions interfering with drug absorption",
                    "requirements": [
                        {
                            "requirement_type": "interference",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* 4. Persistent toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade >1 severity that is related to prior therapy;",
            "criterions": [
                {
                    "exact_snippets": "Persistent toxicity ... NCI CTCAE Grade >1 severity ... related to prior therapy",
                    "criterion": "persistent toxicity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "NCI CTCAE Grade"
                            }
                        },
                        {
                            "requirement_type": "relation to prior therapy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}