Raw JSON Patch
[
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"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2021-05"
},
{
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"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2021-06-08"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2021-06-09"
},
{
"op": "replace",
"path": "/protocolSection/eligibilityModule/eligibilityCriteria",
"value": "<p>Inclusion Criteria:</p><ul><li>Locally advanced, unresectable, or metastatic disease based on most recent imaging.</li><li><p>The respective cohorts for patient inclusion are:</p><ul><li>Cohort 1: Biliary tract cancer</li><li>Cohort 2: Bladder cancer</li><li>Cohort 3: Cervical cancer</li><li>Cohort 4: Endometrial cancer</li><li>Cohort 5: Epithelial ovarian cancer</li><li>Cohort 6: Pancreatic cancer</li><li>Cohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.</li></ul></li><li>Progressed following prior treatment or who have no satisfactory alternative treatment option.</li><li>Prior HER2 targeting therapy is permitted.</li><li>HER2 expression for eligibility may be based on local or central assessment.</li><li>Has measurable target disease assessed by the Investigator based on RECIST version 1.1.</li><li>Has protocol- defined adequate organ function including cardiac, renal and hepatic function.</li></ul><p>Exclusion Criteria:</p><ul><li>History of non-infectious pneumonitis/ILD that required steroids, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening</li><li>Lung-specific intercurrent clinically significant severe illnesses</li><li>Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals</li><li>Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART</li><li>Known Somatic DNA mutation of HER2 (ERBB2) without tumoral HER2 protein expression.</li><li>Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, adenocarcinoma of the gastric body or gastro-esophageal junction, or non-small cell lung cancer.</li><li>Medical conditions that may interfere with the subject's participation in the study.</li></ul>"
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