2024-512442-41-00Active, not recruitingPhase 1/2
Clinical trial of patritumab deruxtecan in people with gastrointestinal cancers
A Phase 1/2 Study to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Gastrointestinal Cancers
Source: EU CTIS (euclinicaltrials.eu) · Last updated 17 Apr 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 2 Aug 2024
- Start date
- 3 Dec 2024
- Lead sponsor
- Merck Sharp & Dohme LLC
- EU CT number
- 2024-512442-41-00
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 48
- 10 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Active, not recruiting |
| Hospital Clínico San Carlos | Madrid | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Central De Asturias | Oviedo | Spain | Active, not recruiting |
| Assistance Publique Hopitaux De Paris | Clichy | France | Completed |
| Hopital De La Croix-Rousse | Lyon Cedex 04 | France | Completed |
| Centre De Lutte Contre Le Cancer Eugene Marquis | Rennes Cedex | France | Completed |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | Italy | Active, not recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori | Milan | Italy | Active, not recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Italy | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.