{
"info": {
"nct_id": "NCT04397276",
"official_title": "A Phase 1 Study of JNJ-70218902, a T Cell Redirecting Agent, in Advanced Stage Solid Tumors",
"inclusion_criteria": "* Histology: Metastatic castration-resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma. Adenocarcinoma with small-cell or neuroendocrine features is allowed\n* Measurable or evaluable disease\n* Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy or chemotherapy\n* If the participant is receiving treatment with gonadotropin-releasing hormone agonists or antagonist analogs (GnRH), this therapy must have been initiated prior to first dose of study drug and must be continued throughout the study\n* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1\n* Adequate organs functions\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Known brain metastases\n* Concurrent use of any other anticancer treatment or investigational agent for the treatment of advanced disease\n* Toxicities related to prior anticancer treatments have not returned to Grade less than or equal to (<=) 1 or baseline, except for alopecia and vitiligo\n* Solid organ or bone marrow transplantation\n* Known allergies, hypersensitivity, or intolerance to JNJ-70218902 or its excipients\n* Certain comorbidities",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Histology: Metastatic castration-resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma. Adenocarcinoma with small-cell or neuroendocrine features is allowed",
"criterions": [
{
"exact_snippets": "Metastatic castration-resistant prostate cancer (mCRPC)",
"criterion": "prostate cancer type",
"requirement": {
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"expected_value": "metastatic castration-resistant"
}
},
{
"exact_snippets": "histologic confirmation of adenocarcinoma",
"criterion": "adenocarcinoma",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
},
{
"exact_snippets": "Adenocarcinoma with small-cell or neuroendocrine features is allowed",
"criterion": "adenocarcinoma features",
"requirement": {
"requirement_type": "allowed features",
"expected_value": [
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"neuroendocrine"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Metastatic castration-resistant prostate cancer (mCRPC)",
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"requirement": {
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}
},
{
"exact_snippets": "histologic confirmation of adenocarcinoma",
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}
}
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{
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},
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"line": "* Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy or chemotherapy",
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{
"exact_snippets": "Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy",
"criterion": "novel androgen receptor (AR)-targeted therapy",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 1,
"unit": "N/A"
}
}
},
{
"exact_snippets": "Prior treatment with at least 1 prior ... chemotherapy",
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"requirement": {
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"operator": ">=",
"value": 1,
"unit": "N/A"
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"expected_value": {
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"value": 1,
"unit": "N/A"
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"operator": ">=",
"value": 1,
"unit": "N/A"
}
}
}
]
}
},
{
"identified_line": {
"line": "* If the participant is receiving treatment with gonadotropin-releasing hormone agonists or antagonist analogs (GnRH), this therapy must have been initiated prior to first dose of study drug and must be continued throughout the study",
"criterions": [
{
"exact_snippets": "participant is receiving treatment with gonadotropin-releasing hormone agonists or antagonist analogs (GnRH)",
"criterion": "GnRH therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "therapy must have been initiated prior to first dose of study drug",
"criterion": "GnRH therapy initiation",
"requirement": {
"requirement_type": "timing",
"expected_value": "prior to first dose of study drug"
}
},
{
"exact_snippets": "therapy ... must be continued throughout the study",
"criterion": "GnRH therapy continuation",
"requirement": {
"requirement_type": "duration",
"expected_value": "throughout the study"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "participant is receiving treatment with gonadotropin-releasing hormone agonists or antagonist analogs (GnRH)",
"criterion": "GnRH therapy",
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"expected_value": true
}
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}
}
]
},
{
"exact_snippets": "therapy ... must be continued throughout the study",
"criterion": "GnRH therapy continuation",
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}
}
]
}
},
{
"identified_line": {
"line": "* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1",
"criterion": "ECOG performance status",
"requirement": {
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"expected_value": [
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"1"
]
}
}
]
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"logical_structure": {
"and_criteria": [
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"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1",
"criterion": "ECOG performance status",
"requirement": {
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"expected_value": [
"0",
"1"
]
}
}
]
}
},
{
"identified_line": {
"line": "* Adequate organs functions",
"criterions": [
{
"exact_snippets": "Adequate organs functions",
"criterion": "organ functions",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Adequate organs functions",
"criterion": "organ functions",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
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"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
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"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must be MALE",
"criterions": [
{
"exact_snippets": "Must be MALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "male"
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "Must be MALE",
"criterion": "gender",
"requirement": {
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"expected_value": "male"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Known brain metastases",
"criterions": [
{
"exact_snippets": "Known brain metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Known brain metastases",
"criterion": "brain metastases",
"requirement": {
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"expected_value": true
}
}
}
},
{
"identified_line": {
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"criterions": [
{
"exact_snippets": "Concurrent use of any other anticancer treatment",
"criterion": "concurrent anticancer treatment",
"requirement": {
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"expected_value": false
}
},
{
"exact_snippets": "Concurrent use of any other ... investigational agent for the treatment of advanced disease",
"criterion": "concurrent investigational agent",
"requirement": {
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"expected_value": false
}
}
]
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"criterion": "concurrent anticancer treatment",
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"expected_value": false
}
},
{
"exact_snippets": "Concurrent use of any other ... investigational agent for the treatment of advanced disease",
"criterion": "concurrent investigational agent",
"requirement": {
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"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Toxicities related to prior anticancer treatments have not returned to Grade less than or equal to (<=) 1 or baseline, except for alopecia and vitiligo",
"criterions": [
{
"exact_snippets": "Toxicities related to prior anticancer treatments have not returned to Grade less than or equal to (<=) 1 or baseline",
"criterion": "toxicities related to prior anticancer treatments",
"requirement": {
"requirement_type": "grade",
"expected_value": {
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"value": 1,
"unit": "Grade"
}
}
},
{
"exact_snippets": "Toxicities related to prior anticancer treatments have not returned to Grade less than or equal to (<=) 1 or baseline",
"criterion": "toxicities related to prior anticancer treatments",
"requirement": {
"requirement_type": "grade",
"expected_value": "baseline"
}
},
{
"exact_snippets": "except for alopecia",
"criterion": "alopecia",
"requirement": {
"requirement_type": "exclusion",
"expected_value": true
}
},
{
"exact_snippets": "except for ... vitiligo",
"criterion": "vitiligo",
"requirement": {
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"expected_value": true
}
}
]
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"logical_structure": {
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}
}
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{
"identified_line": {
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"criterion": "solid organ transplantation",
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"expected_value": true
}
},
{
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}
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"criterion": "bone marrow transplantation",
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"expected_value": true
}
}
]
}
},
{
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"line": "* Known allergies, hypersensitivity, or intolerance to JNJ-70218902 or its excipients",
"criterions": [
{
"exact_snippets": "Known allergies, hypersensitivity, or intolerance to JNJ-70218902",
"criterion": "allergies, hypersensitivity, or intolerance",
"requirement": {
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"expected_value": false
}
},
{
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"expected_value": false
}
}
]
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}
},
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"requirement": {
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"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Certain comorbidities",
"criterions": [
{
"exact_snippets": "Certain comorbidities",
"criterion": "comorbidities",
"requirement": {
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"expected_value": false
}
}
]
},
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}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
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"identified_line": {
"line": "* Measurable or evaluable disease",
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{
"exact_snippets": "Measurable or evaluable disease",
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]
}
}
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}
}
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}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}