{
"info": {
"nct_id": "NCT05554666",
"official_title": "A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ASKG315 as a Single Agent in Patients With Locally Advanced or Metastatic Malignant Solid Tumors.",
"inclusion_criteria": "1. Male or female ≥ 18 years of age.\n2. Histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.\n3. Measurable disease, per RECIST v1.1.\n4. ECOG Performance Status of ≤ 2.\n5. Life expectancy of ≥3 months, in the opinion of the Investigator.\n6. Adequate organ function defined.\n7. Fertile patients must be willing to use effective contraceptive measures (hormonal or barrier methods or abstinence, etc.) during the trial and at least 90 days after the last dose;negative serum pregnancy test for female patients within 7 days prior to the first dose of the study drug or documentation of lack of childbearing potential.\n8. Voluntarily enrolled and signed the informed consent form, followed the experimental treatment plan and visit arrangement.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "1. Received chemotherapy within 3 weeks prior to Cycle 1 Day 1; received radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, or any other anti-tumor treatments within 4 weeks prior to Cycle 1 Day 1.\n2. Received any other investigational drug for treatment that is not commercially available within 4 weeks prior to Cycle 1 Day 1.\n3. Had major organ surgery or significant trauma within 4 weeks prior to C1D1 or planning elective surgery during the study period.\n4. Received systemic glucocorticoid or other immunosuppressant treatment within 2 weeks prior to C1D1.\n5. Received immunomodulatory drugs, including but not limited to thymosin and interferon, within 2 weeks prior to C1D1.\n6. Received a live attenuated vaccine within 4 weeks prior to C1D1.\n7. Received IL-2 or IL-15 therapy within 4 weeks prior to C1D1.\n8. History of hematologic stem cell transplant or solid organ transplant.\n9. Adverse reactions to previous antitumor therapy have not recovered to CTCAE 5.0 grade ≤ 1.\n10. Cerebral parenchymal metastasis or meningeal metastasis with clinical symptoms.\n11. Serious infection requiring intravenous infusion or hospitalization, or active viral infection.\n12. Current clinically significant interstitial lung disease.\n13. History of serious cardiovascular or cerebrovascular diseases.\n14. Active or recurrent autoimmune diseases.\n15. History of Grade ≥ 3 Immune-Related Adverse Events (irAE) or Grade ≥ 2 immunotherapy-associated myocarditis associated.\n16. Other malignancies within 5 years.\n17. Bleeding symptoms of CTCAE 5.0 grade ≥3 within 4 weeks prior to C1D1.\n18. Symptomatic with uncontrolled ascites or pleural effusion.\n19. Hyperglycemia that cannot be stably controlled.\n20. History of a grade ≥ 3 allergic reaction to protein drugs.\n21. Known to have alcohol or drug dependence.\n22. Severe mental disorder or poor compliance.\n23. Pregnant or nursing women\n24. Subjects should be excluded in the opinion of investigators.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "1. Male or female ≥ 18 years of age.",
"criterions": [
{
"exact_snippets": "Male or female",
"criterion": "gender",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "≥ 18 years of age",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "Male or female",
"criterion": "gender",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "≥ 18 years of age",
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "2. Histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.",
"criterions": [
{
"exact_snippets": "Histologically or cytologically confirmed",
"criterion": "confirmation method",
"requirement": {
"requirement_type": "method",
"expected_value": [
"histologically",
"cytologically"
]
}
},
{
"exact_snippets": "advanced malignant solid tumor",
"criterion": "tumor type",
"requirement": {
"requirement_type": "type",
"expected_value": "advanced malignant solid tumor"
}
},
{
"exact_snippets": "refractory to or intolerant of all standard therapy",
"criterion": "response to standard therapy",
"requirement": {
"requirement_type": "response",
"expected_value": [
"refractory",
"intolerant"
]
}
},
{
"exact_snippets": "for which no standard therapy is available",
"criterion": "availability of standard therapy",
"requirement": {
"requirement_type": "availability",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
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"requirement": {
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"histologically",
"cytologically"
]
}
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"exact_snippets": "advanced malignant solid tumor",
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}
}
]
},
{
"or_criteria": [
{
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"criterion": "response to standard therapy",
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"expected_value": [
"refractory",
"intolerant"
]
}
},
{
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"criterion": "availability of standard therapy",
"requirement": {
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"expected_value": false
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "3. Measurable disease, per RECIST v1.1.",
"criterions": [
{
"exact_snippets": "Measurable disease, per RECIST v1.1.",
"criterion": "measurable disease",
"requirement": {
"requirement_type": "measurement standard",
"expected_value": "RECIST v1.1"
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Measurable disease, per RECIST v1.1.",
"criterion": "measurable disease",
"requirement": {
"requirement_type": "measurement standard",
"expected_value": "RECIST v1.1"
}
}
]
}
},
{
"identified_line": {
"line": "4. ECOG Performance Status of ≤ 2.",
"criterions": [
{
"exact_snippets": "ECOG Performance Status of ≤ 2",
"criterion": "ECOG Performance Status",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "ECOG Performance Status of ≤ 2",
"criterion": "ECOG Performance Status",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "N/A"
}
}
}
]
}
},
{
"identified_line": {
"line": "5. Life expectancy of ≥3 months, in the opinion of the Investigator.",
"criterions": [
{
"exact_snippets": "Life expectancy of ≥3 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Life expectancy of ≥3 months",
"criterion": "life expectancy",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
},
{
"exact_snippets": "in the opinion of the Investigator",
"criterion": "investigator's opinion",
"requirement": {
"requirement_type": "approval",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "6. Adequate organ function defined.",
"criterions": [
{
"exact_snippets": "Adequate organ function",
"criterion": "organ function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Adequate organ function",
"criterion": "organ function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "7. Fertile patients must be willing to use effective contraceptive measures (hormonal or barrier methods or abstinence, etc.) during the trial and at least 90 days after the last dose;negative serum pregnancy test for female patients within 7 days prior to the first dose of the study drug or documentation of lack of childbearing potential.",
"criterions": [
{
"exact_snippets": "Fertile patients",
"criterion": "fertility",
"requirement": {
"requirement_type": "status",
"expected_value": "fertile"
}
},
{
"exact_snippets": "willing to use effective contraceptive measures (hormonal or barrier methods or abstinence, etc.) during the trial and at least 90 days after the last dose",
"criterion": "contraceptive use",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "willing to use effective contraceptive measures (hormonal or barrier methods or abstinence, etc.) during the trial and at least 90 days after the last dose",
"criterion": "contraceptive use",
"requirement": {
"requirement_type": "duration",
"expected_value": "during the trial and at least 90 days after the last dose"
}
},
{
"exact_snippets": "negative serum pregnancy test for female patients within 7 days prior to the first dose of the study drug",
"criterion": "serum pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
},
{
"exact_snippets": "negative serum pregnancy test for female patients within 7 days prior to the first dose of the study drug",
"criterion": "serum pregnancy test",
"requirement": {
"requirement_type": "timing",
"expected_value": "within 7 days prior to the first dose of the study drug"
}
},
{
"exact_snippets": "documentation of lack of childbearing potential",
"criterion": "childbearing potential",
"requirement": {
"requirement_type": "documentation",
"expected_value": "lack of childbearing potential"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"condition": {
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"criterion": "fertility",
"requirement": {
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"expected_value": "fertile"
}
},
"then_criteria": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "willing to use effective contraceptive measures (hormonal or barrier methods or abstinence, etc.) during the trial and at least 90 days after the last dose",
"criterion": "contraceptive use",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "willing to use effective contraceptive measures (hormonal or barrier methods or abstinence, etc.) during the trial and at least 90 days after the last dose",
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}
}
]
},
{
"and_criteria": [
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"criterion": "serum pregnancy test",
"requirement": {
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"expected_value": "negative"
}
},
{
"exact_snippets": "negative serum pregnancy test for female patients within 7 days prior to the first dose of the study drug",
"criterion": "serum pregnancy test",
"requirement": {
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}
}
]
}
]
},
"else_criteria": {
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"criterion": "childbearing potential",
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}
}
}
]
}
},
{
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"criterions": [
{
"exact_snippets": "Voluntarily enrolled",
"criterion": "voluntary enrollment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "signed the informed consent form",
"criterion": "informed consent form",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
},
{
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"criterion": "experimental treatment plan",
"requirement": {
"requirement_type": "adherence",
"expected_value": true
}
},
{
"exact_snippets": "visit arrangement",
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"requirement": {
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"expected_value": true
}
}
]
},
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"expected_value": true
}
},
{
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"requirement": {
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"expected_value": true
}
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},
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}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 80 Years",
"criterions": [
{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
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{
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"value": 80,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "1. Received chemotherapy within 3 weeks prior to Cycle 1 Day 1; received radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, or any other anti-tumor treatments within 4 weeks prior to Cycle 1 Day 1.",
"criterions": [
{
"exact_snippets": "Received chemotherapy within 3 weeks prior to Cycle 1 Day 1",
"criterion": "chemotherapy",
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"expected_value": {
"operator": "<=",
"value": 3,
"unit": "weeks"
}
}
},
{
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"criterion": "radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, or any other anti-tumor treatments",
"requirement": {
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"expected_value": {
"operator": "<=",
"value": 4,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
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"and_criteria": [
{
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"value": 3,
"unit": "weeks"
}
}
}
]
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"requirement": {
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"expected_value": {
"operator": "<=",
"value": 4,
"unit": "weeks"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "2. Received any other investigational drug for treatment that is not commercially available within 4 weeks prior to Cycle 1 Day 1.",
"criterions": [
{
"exact_snippets": "Received any other investigational drug for treatment that is not commercially available within 4 weeks prior to Cycle 1 Day 1.",
"criterion": "investigational drug",
"requirement": {
"requirement_type": "receipt",
"expected_value": false
}
},
{
"exact_snippets": "Received any other investigational drug for treatment that is not commercially available within 4 weeks prior to Cycle 1 Day 1.",
"criterion": "investigational drug",
"requirement": {
"requirement_type": "availability",
"expected_value": "not commercially available"
}
},
{
"exact_snippets": "Received any other investigational drug for treatment that is not commercially available within 4 weeks prior to Cycle 1 Day 1.",
"criterion": "investigational drug",
"requirement": {
"requirement_type": "time frame",
"expected_value": "within 4 weeks prior to Cycle 1 Day 1"
}
}
]
},
"logical_structure": {
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{
"and_criteria": [
{
"exact_snippets": "Received any other investigational drug for treatment that is not commercially available within 4 weeks prior to Cycle 1 Day 1.",
"criterion": "investigational drug",
"requirement": {
"requirement_type": "receipt",
"expected_value": false
}
},
{
"exact_snippets": "Received any other investigational drug for treatment that is not commercially available within 4 weeks prior to Cycle 1 Day 1.",
"criterion": "investigational drug",
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},
{
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}
}
]
}
},
{
"identified_line": {
"line": "3. Had major organ surgery or significant trauma within 4 weeks prior to C1D1 or planning elective surgery during the study period.",
"criterions": [
{
"exact_snippets": "Had major organ surgery ... within 4 weeks prior to C1D1",
"criterion": "major organ surgery",
"requirement": {
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"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
},
{
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"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
},
{
"exact_snippets": "planning elective surgery during the study period",
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"expected_value": true
}
}
]
},
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{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Had major organ surgery ... within 4 weeks prior to C1D1",
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"criterions": [
{
"exact_snippets": "Received systemic glucocorticoid or other immunosuppressant treatment within 2 weeks prior to C1D1.",
"criterion": "systemic glucocorticoid treatment",
"requirement": {
"requirement_type": "timeframe",
"expected_value": "within 2 weeks prior to C1D1"
}
},
{
"exact_snippets": "Received systemic glucocorticoid or other immunosuppressant treatment within 2 weeks prior to C1D1.",
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"expected_value": "within 2 weeks prior to C1D1"
}
}
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},
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{
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}
},
{
"exact_snippets": "Received systemic glucocorticoid or other immunosuppressant treatment within 2 weeks prior to C1D1.",
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}
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},
{
"identified_line": {
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{
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"expected_value": true
}
},
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"unit": "weeks"
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"expected_value": true
}
},
{
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"unit": "weeks"
}
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}
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}
},
{
"identified_line": {
"line": "6. Received a live attenuated vaccine within 4 weeks prior to C1D1.",
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{
"exact_snippets": "Received a live attenuated vaccine within 4 weeks prior to C1D1.",
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"requirement": {
"requirement_type": "time since administration",
"expected_value": {
"operator": "<=",
"value": 4,
"unit": "weeks"
}
}
}
]
},
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"expected_value": {
"operator": "<=",
"value": 4,
"unit": "weeks"
}
}
}
}
},
{
"identified_line": {
"line": "8. History of hematologic stem cell transplant or solid organ transplant.",
"criterions": [
{
"exact_snippets": "History of hematologic stem cell transplant",
"criterion": "hematologic stem cell transplant",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... solid organ transplant",
"criterion": "solid organ transplant",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
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"exact_snippets": "History of hematologic stem cell transplant",
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"expected_value": true
}
},
{
"exact_snippets": "History of ... solid organ transplant",
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"requirement": {
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "10. Cerebral parenchymal metastasis or meningeal metastasis with clinical symptoms.",
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{
"exact_snippets": "Cerebral parenchymal metastasis",
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"exact_snippets": "meningeal metastasis",
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"requirement_type": "presence",
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{
"exact_snippets": "clinical symptoms",
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{
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{
"exact_snippets": "Cerebral parenchymal metastasis",
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"exact_snippets": "meningeal metastasis",
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"line": "11. Serious infection requiring intravenous infusion or hospitalization, or active viral infection.",
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"exact_snippets": "Serious infection requiring intravenous infusion or hospitalization",
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"exact_snippets": "Serious infection requiring intravenous infusion or hospitalization",
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{
"exact_snippets": "active viral infection",
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{
"and_criteria": [
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"exact_snippets": "Serious infection requiring intravenous infusion or hospitalization",
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{
"exact_snippets": "active viral infection",
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"line": "12. Current clinically significant interstitial lung disease.",
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"exact_snippets": "Current clinically significant interstitial lung disease.",
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{
"exact_snippets": "Current clinically significant interstitial lung disease.",
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"requirement_type": "clinical significance",
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}
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{
"exact_snippets": "Current clinically significant interstitial lung disease.",
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{
"exact_snippets": "Current clinically significant interstitial lung disease.",
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"requirement_type": "clinical significance",
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}
},
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"identified_line": {
"line": "13. History of serious cardiovascular or cerebrovascular diseases.",
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"exact_snippets": "History of serious cardiovascular ... diseases.",
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},
{
"exact_snippets": "History of serious cardiovascular ... diseases.",
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"requirement_type": "history",
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}
},
{
"exact_snippets": "History of serious ... cerebrovascular diseases.",
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{
"exact_snippets": "History of serious ... cerebrovascular diseases.",
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},
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"and_criteria": [
{
"exact_snippets": "History of serious cardiovascular ... diseases.",
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"requirement_type": "severity",
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{
"exact_snippets": "History of serious cardiovascular ... diseases.",
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"requirement_type": "history",
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{
"and_criteria": [
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"exact_snippets": "History of serious ... cerebrovascular diseases.",
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{
"exact_snippets": "History of serious ... cerebrovascular diseases.",
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"requirement_type": "history",
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]
}
},
{
"identified_line": {
"line": "14. Active or recurrent autoimmune diseases.",
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"exact_snippets": "Active or recurrent autoimmune diseases",
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"requirement_type": "status",
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"active",
"recurrent"
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"exact_snippets": "Active or recurrent autoimmune diseases",
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"active",
"recurrent"
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},
{
"identified_line": {
"line": "15. History of Grade ≥ 3 Immune-Related Adverse Events (irAE) or Grade ≥ 2 immunotherapy-associated myocarditis associated.",
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"exact_snippets": "History of Grade ≥ 3 Immune-Related Adverse Events (irAE)",
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"requirement_type": "severity",
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"operator": ">=",
"value": 3,
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}
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"exact_snippets": "History of ... Grade ≥ 2 immunotherapy-associated myocarditis",
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"requirement_type": "severity",
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"operator": ">=",
"value": 2,
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"exact_snippets": "History of Grade ≥ 3 Immune-Related Adverse Events (irAE)",
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"requirement_type": "severity",
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"operator": ">=",
"value": 3,
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{
"exact_snippets": "History of ... Grade ≥ 2 immunotherapy-associated myocarditis",
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"operator": ">=",
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{
"identified_line": {
"line": "16. Other malignancies within 5 years.",
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"exact_snippets": "Other malignancies within 5 years.",
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"requirement_type": "time since diagnosis",
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"operator": "<=",
"value": 5,
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"exact_snippets": "Other malignancies within 5 years.",
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"requirement_type": "time since diagnosis",
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"operator": "<=",
"value": 5,
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}
}
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"identified_line": {
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"exact_snippets": "Bleeding symptoms of CTCAE 5.0 grade ≥3 within 4 weeks prior to C1D1.",
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"requirement_type": "severity",
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"exact_snippets": "Bleeding symptoms of CTCAE 5.0 grade ≥3 within 4 weeks prior to C1D1.",
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"exact_snippets": "Bleeding symptoms of CTCAE 5.0 grade ≥3 within 4 weeks prior to C1D1.",
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"exact_snippets": "Bleeding symptoms of CTCAE 5.0 grade ≥3 within 4 weeks prior to C1D1.",
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"exact_snippets": "Symptomatic with uncontrolled ascites",
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"exact_snippets": "Symptomatic with uncontrolled ascites",
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"exact_snippets": "Symptomatic with uncontrolled ... pleural effusion",
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"exact_snippets": "Symptomatic with uncontrolled ... pleural effusion",
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"exact_snippets": "Symptomatic with uncontrolled ... pleural effusion",
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"exact_snippets": "Symptomatic with uncontrolled ... pleural effusion",
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"identified_line": {
"line": "19. Hyperglycemia that cannot be stably controlled.",
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"exact_snippets": "Hyperglycemia that cannot be stably controlled.",
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"exact_snippets": "History of a grade ≥ 3 allergic reaction to protein drugs.",
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},
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"exact_snippets": "alcohol ... dependence",
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"exact_snippets": "alcohol ... dependence",
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},
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"exact_snippets": "Severe mental disorder",
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"exact_snippets": "poor compliance",
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{
"exact_snippets": "poor compliance",
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},
{
"exact_snippets": "nursing women",
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{
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]
}
},
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"identified_line": {
"line": "24. Subjects should be excluded in the opinion of investigators.",
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}
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}
],
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"identified_line": {
"line": "Healthy volunteers allowed",
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"exact_snippets": "Healthy volunteers allowed",
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}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
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{
"exact_snippets": "minimum age of 18 Years",
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"operator": ">=",
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],
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"line": "7. Received IL-2 or IL-15 therapy within 4 weeks prior to C1D1.",
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"exact_snippets": "Received IL-2 or IL-15 therapy within 4 weeks prior to C1D1.",
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"value": 4,
"unit": "weeks"
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},
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"exact_snippets": "Received IL-2 or IL-15 therapy within 4 weeks prior to C1D1.",
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}
}
]
}
},
{
"identified_line": {
"line": "9. Adverse reactions to previous antitumor therapy have not recovered to CTCAE 5.0 grade ≤ 1.",
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"exact_snippets": "Adverse reactions to previous antitumor therapy have not recovered to CTCAE 5.0 grade ≤ 1.",
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"value": 1,
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}
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]
},
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"value": 1,
"unit": "CTCAE 5.0 grade"
}
}
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}
}
],
"failed_miscellaneous": []
}