Severity is deterministic uncalibrated triage metadata, not validated review priority. Operation-level severity
is inferred from deterministic path rules. Rule matches shown per operation are approximate previews (they skip
the pipeline's suppression passes); the authoritative classification is the stored
event record.
eligibility_criteria_changeEligibility criteria changes can alter the studied population.
Before
<p>Key Inclusion Criteria:</p><ul><li>Patient must have an advanced solid tumor with documented HER2-protein expression or gene amplification for which approved therapies have been exhausted or are not clinically indicated.</li><li>Measurable disease as determined by RECIST v.1.1.</li><li>Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.</li><li>Tumor tissue (archival or collected prior to the study start) available for exploratory biomarker evaluation.</li></ul><p>Key Exclusion Criteria:</p><ul><li>History of severe hypersensitivity to any ingredient of the study drug(s), including trastuzumab or other monoclonal antibody.</li><li>Previous treatment with a TLR 7, TLR 8 or a TLR 7/8 agonist.</li><li>For the combination portion of the study, previous treatment with an anti-PD1 or anti- PD-L1 therapy.</li><li>Impaired cardiac function or history of clinically significant cardiac disease</li><li>Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.</li><li>Untreated central nervous system (CNS), epidural tumor or metastasis, or brain metastasis.</li></ul><p>Other protocol defined inclusion/exclusion criteria may apply.</p>
After
<p>Key Inclusion Criteria:</p><ul><li>Patient must have an advanced solid tumor with documented HER2-protein expression or gene amplification for which approved therapies have been exhausted or are not clinically indicated.</li><li>Measurable disease as determined by RECIST v.1.1.</li><li>Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.</li><li>Tumor tissue (archival or collected prior to the study start) available for exploratory biomarker evaluation.</li></ul><p>Key Exclusion Criteria:</p><ul><li>History of severe hypersensitivity to any ingredient of the study drug(s), including trastuzumab or other monoclonal antibody.</li><li>Previous treatment with a TLR 7, TLR 8 or a TLR 7/8 agonist.</li><li>Impaired cardiac function or history of clinically significant cardiac disease</li><li>Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.</li><li>Untreated central nervous system (CNS), epidural tumor or metastasis, or brain metastasis.</li></ul><p>Other protocol defined inclusion/exclusion criteria may apply.</p>
Secondary outcomesAdditional endpoints and outcome descriptions.Triage: High3 ops
[
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2021-02"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2021-02-04"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2021-02-08"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6/measure",
"value": "Overall response rate (ORR) using RECIST 1.1 and iRECIST"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/8/measure",
"value": "Disease control rate (DCR) of confirmed CR, PR, or stable disease (SD) lasting 4 or more weeks"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/10/description",
"value": "Escalation and expansion periods"
},
{
"op": "replace",
"path": "/protocolSection/eligibilityModule/eligibilityCriteria",
"value": "<p>Key Inclusion Criteria:</p><ul><li>Patient must have an advanced solid tumor with documented HER2-protein expression or gene amplification for which approved therapies have been exhausted or are not clinically indicated.</li><li>Measurable disease as determined by RECIST v.1.1.</li><li>Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.</li><li>Tumor tissue (archival or collected prior to the study start) available for exploratory biomarker evaluation.</li></ul><p>Key Exclusion Criteria:</p><ul><li>History of severe hypersensitivity to any ingredient of the study drug(s), including trastuzumab or other monoclonal antibody.</li><li>Previous treatment with a TLR 7, TLR 8 or a TLR 7/8 agonist.</li><li>Impaired cardiac function or history of clinically significant cardiac disease</li><li>Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.</li><li>Untreated central nervous system (CNS), epidural tumor or metastasis, or brain metastasis.</li></ul><p>Other protocol defined inclusion/exclusion criteria may apply.</p>"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/1",
"value": {
"zip": "20007",
"city": "Washington D.C.",
"state": "District of Columbia",
"status": "RECRUITING",
"country": "United States",
"contacts": [
{
"name": "Stephanie Wagner, RN",
"role": "CONTACT",
"email": "sw1095@georgetown.edu",
"phone": "202-687-9782"
}
],
"facility": "Georgetown University Medical Center",
"geoPoint": {
"lat": 38.89511,
"lon": -77.03637
}
}
}
]