Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (HERTHENA-PanTumor02)
A Phase 1/2 Study to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Gastrointestinal Cancers
Sponsor: Merck Sharp & Dohme LLC + Daiichi Sankyo
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Dose-Escalation Phase)
Time frame: Up to 21 days
Number of Participants with One or More Adverse Events (AEs)
Time frame: Up to approximately 44 months
Number of Participants who Discontinue Study Intervention Due to an AE
Time frame: Up to approximately 44 months
Objective Response Rate (ORR)
Time frame: Up to approximately 44 months
Secondary Endpoints
Duration of Response (DOR)
Progression Free Survival (PFS)
Overall Survival (OS)
Eligibility Criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has one of the following cancers: * Unresectable or metastatic colorectal cancer. * Advanced and/or unresectable biliary tract cancer (BTC) * Hepatocellular carcinoma (HCC) not amenable to locoregional therapy * Locally advanced unresectable or metastatic gastroesophageal cancer * Has received prior therapy for the cancer. * Has recovered from any side effects due to previous cancer treatment Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a history of (noninfectious) interstitial lung disease (ILD) or pneumonitis that required steroids, or has current ILD or pneumonitis, and/or suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening * Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses * Has evidence…
Read full criteria on CT.gov →✦ Analyst Commentary
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