Clinical trial of patritumab deruxtecan in people with gastrointestinal cancers
Key facts
- Where
- Barcelona, Madrid és Oviedo, SpanyolországSee the 4 sites
- Phase
- 1/2. fázis
Where in Spanyolország
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországNo longer taking part
- Hospital Clínico San CarlosMadrid, SpanyolországNo longer taking part
- Hospital General Universitario Gregorio MarañónMadrid, SpanyolországNo longer taking part
- Hospital Universitario Central De AsturiasOviedo, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- EU 2024-512442-41-00
- Record updated
- 2026. április 17.
- Original description
1. To evaluate the safety and tolerability of patritumab deruxtecan (HER3-DXd)Read full original descriptionShow less
A Phase 1/2 Study to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Gastrointestinal Cancers
1. To evaluate the safety and tolerability of patritumab deruxtecan (HER3-DXd)
2. To evaluate the confirmed ORR per RECIST 1.1 as assessed by BICR (Cohort 1, Cohort 2, Cohort 4, and participants who received the preliminary RP2D in Cohort 3)
Inclusion: 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: 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 of any leptomeningeal disease; Has clinically significant corneal disease; Has uncontrolled, significant cardiovascular disease or cerebrovascular disease; Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.