{
    "info": {
        "nct_id": "NCT05538572",
        "official_title": "A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT3645 in Participants With Select Advanced or Metastatic Solid Tumors",
        "inclusion_criteria": "* Histologically confirmed advanced, recurrent, or metastatic solid tumor malignancy that have either progress or ineligible for standard of care therapy:\n\n  1. HR+ and HER2- or HR+ and HER2+ breast cancer\n  2. Recurrent GBM (IDH wild type) or CDKN2A/B homozygous deleted IDH-mutant astrocytoma\n  3. KRAS-mutant or SMARCA4 loss NSCLC\n  4. CDK pathway alternation in any of the following tumor types: malignant mesothelioma, HPV-negative HNSCC (including oral cavity, oropharynx, hypopharynx, and larynx), sarcoma, or NSCLC\n  5. Estrogen receptor positive with TP53 wild type endometrial cancer\n* Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures\n* Must have measurable or non-measureable (but evaluable) disease\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or Karnofsky Performance Status (KPS) ≥80% (KPS is for GBM only)\n* Adequate organ function.\n* Able to swallow and retain oral medication.\n* Must provide either archival or fresh tumor tissue sample during screening.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Participants with advanced, symptomatic, extensive visceral disease.\n* Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, any upper gastrointestinal surgery including gastric resection, known malabsorption syndrome, or other condition that may impair absorption of PRT3645.\n* Treatment with strong inhibitors of CYP3A4.\n* History of another malignancy within 3 years except for adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancies, or malignancies previously treated with curative intent and not on active therapy or expected to require treatment or recurrence during the study.\n* Clinically significant or uncontrolled cardiac disease, uncontrolled electrolyte disorders, uncontrolled or symptomatic CNS metastases or leptomeningeal disease except for GBM.\n* Endometrial cancer patients who had received prior treatment with a CDK 4/6 inhibitor.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically confirmed advanced, recurrent, or metastatic solid tumor malignancy that have either progress or ineligible for standard of care therapy:",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed advanced, recurrent, or metastatic solid tumor malignancy",
                    "criterion": "solid tumor malignancy",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "advanced",
                                "recurrent",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "that have either progress or ineligible for standard of care therapy",
                    "criterion": "eligibility for standard of care therapy",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": "ineligible"
                        },
                        {
                            "requirement_type": "progression",
                            "expected_value": "progressed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. HR+ and HER2- or HR+ and HER2+ breast cancer",
            "criterions": [
                {
                    "exact_snippets": "HR+",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2-",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2+",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "breast cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "breast cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Recurrent GBM (IDH wild type) or CDKN2A/B homozygous deleted IDH-mutant astrocytoma",
            "criterions": [
                {
                    "exact_snippets": "Recurrent GBM (IDH wild type)",
                    "criterion": "GBM",
                    "requirements": [
                        {
                            "requirement_type": "recurrence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "IDH status",
                            "expected_value": "wild type"
                        }
                    ]
                },
                {
                    "exact_snippets": "CDKN2A/B homozygous deleted IDH-mutant astrocytoma",
                    "criterion": "astrocytoma",
                    "requirements": [
                        {
                            "requirement_type": "CDKN2A/B status",
                            "expected_value": "homozygous deleted"
                        },
                        {
                            "requirement_type": "IDH status",
                            "expected_value": "mutant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. KRAS-mutant or SMARCA4 loss NSCLC",
            "criterions": [
                {
                    "exact_snippets": "KRAS-mutant",
                    "criterion": "KRAS mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "SMARCA4 loss",
                    "criterion": "SMARCA4 loss",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "NSCLC",
                    "criterion": "NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. CDK pathway alternation in any of the following tumor types: malignant mesothelioma, HPV-negative HNSCC (including oral cavity, oropharynx, hypopharynx, and larynx), sarcoma, or NSCLC",
            "criterions": [
                {
                    "exact_snippets": "CDK pathway alternation",
                    "criterion": "CDK pathway alternation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "malignant mesothelioma",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "malignant mesothelioma"
                        }
                    ]
                },
                {
                    "exact_snippets": "HPV-negative HNSCC",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "HPV-negative HNSCC"
                        }
                    ]
                },
                {
                    "exact_snippets": "sarcoma",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "sarcoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "NSCLC",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "NSCLC"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Estrogen receptor positive with TP53 wild type endometrial cancer",
            "criterions": [
                {
                    "exact_snippets": "Estrogen receptor positive",
                    "criterion": "estrogen receptor",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "TP53 wild type",
                    "criterion": "TP53",
                    "requirements": [
                        {
                            "requirement_type": "mutation status",
                            "expected_value": "wild type"
                        }
                    ]
                },
                {
                    "exact_snippets": "endometrial cancer",
                    "criterion": "endometrial cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures",
            "criterions": [
                {
                    "exact_snippets": "Willing and able to comply with all scheduled visits",
                    "criterion": "compliance with scheduled visits",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willing and able to comply with ... treatment plan",
                    "criterion": "compliance with treatment plan",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willing and able to comply with ... laboratory tests",
                    "criterion": "compliance with laboratory tests",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willing and able to comply with ... lifestyle considerations",
                    "criterion": "compliance with lifestyle considerations",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willing and able to comply with ... other study procedures",
                    "criterion": "compliance with other study procedures",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have measurable or non-measureable (but evaluable) disease",
            "criterions": [
                {
                    "exact_snippets": "measurable or non-measureable (but evaluable) disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "non-measurable (but evaluable)"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or Karnofsky Performance Status (KPS) ≥80% (KPS is for GBM only)",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Karnofsky Performance Status (KPS) ≥80%",
                    "criterion": "Karnofsky Performance Status (KPS)",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": {
                                "operator": ">=",
                                "value": 80,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ function.",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function.",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to swallow and retain oral medication.",
            "criterions": [
                {
                    "exact_snippets": "Able to swallow",
                    "criterion": "ability to swallow",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "retain oral medication",
                    "criterion": "ability to retain oral medication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must provide either archival or fresh tumor tissue sample during screening.",
            "criterions": [
                {
                    "exact_snippets": "Must provide either archival or fresh tumor tissue sample during screening.",
                    "criterion": "tumor tissue sample",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "archival",
                                "fresh"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Participants with advanced, symptomatic, extensive visceral disease.",
            "criterions": [
                {
                    "exact_snippets": "advanced, symptomatic, extensive visceral disease",
                    "criterion": "visceral disease",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        },
                        {
                            "requirement_type": "symptoms",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "extent",
                            "expected_value": "extensive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, any upper gastrointestinal surgery including gastric resection, known malabsorption syndrome, or other condition that may impair absorption of PRT3645.",
            "criterions": [
                {
                    "exact_snippets": "Active inflammatory bowel disease",
                    "criterion": "inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic diarrhea",
                    "criterion": "chronic diarrhea",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "short bowel syndrome",
                    "criterion": "short bowel syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any upper gastrointestinal surgery including gastric resection",
                    "criterion": "upper gastrointestinal surgery",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "known malabsorption syndrome",
                    "criterion": "malabsorption syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other condition that may impair absorption of PRT3645",
                    "criterion": "condition impairing absorption of PRT3645",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment with strong inhibitors of CYP3A4.",
            "criterions": [
                {
                    "exact_snippets": "Treatment with strong inhibitors of CYP3A4.",
                    "criterion": "CYP3A4 inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "strong inhibitors"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of another malignancy within 3 years except for adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancies, or malignancies previously treated with curative intent and not on active therapy or expected to require treatment or recurrence during the study.",
            "criterions": [
                {
                    "exact_snippets": "History of another malignancy within 3 years",
                    "criterion": "history of another malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for adequately treated basal cell or squamous cell skin cancer",
                    "criterion": "adequately treated basal cell or squamous cell skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... superficial bladder cancer",
                    "criterion": "superficial bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... prostate intraepithelial neoplasm",
                    "criterion": "prostate intraepithelial neoplasm",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... carcinoma in situ of the cervix",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... other noninvasive or indolent malignancies",
                    "criterion": "other noninvasive or indolent malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... malignancies previously treated with curative intent and not on active therapy or expected to require treatment or recurrence during the study",
                    "criterion": "malignancies previously treated with curative intent",
                    "requirements": [
                        {
                            "requirement_type": "active therapy",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "expected treatment or recurrence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant or uncontrolled cardiac disease, uncontrolled electrolyte disorders, uncontrolled or symptomatic CNS metastases or leptomeningeal disease except for GBM.",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant or uncontrolled cardiac disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "clinically significant",
                                "uncontrolled"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled electrolyte disorders",
                    "criterion": "electrolyte disorders",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled or symptomatic CNS metastases",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "symptoms",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "leptomeningeal disease except for GBM",
                    "criterion": "leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "exception",
                            "expected_value": "GBM"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Endometrial cancer patients who had received prior treatment with a CDK 4/6 inhibitor.",
            "criterions": [
                {
                    "exact_snippets": "Endometrial cancer patients",
                    "criterion": "endometrial cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "received prior treatment with a CDK 4/6 inhibitor",
                    "criterion": "prior treatment with a CDK 4/6 inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}