A Phase 1/2 Study to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Gastrointestinal Cancers

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512442-41-00

Acronym

MK-1022-011

Enrollment

Registered

2024-11-06

Start date

2024-12-03

Completion date

Unknown

Last updated

2025-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Carcinoma, Biliary Tract Carcinoma, Hepatocellular Carcinoma

Brief summary

Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Dose-Escalation Phase), Number of Participants with One or More Adverse Events (AEs), Number of Participants who Discontinue Study Intervention Due to an AE, Objective Response Rate (ORR)

Detailed description

Duration of Response (DOR), Progression Free Survival (PFS), Overall Survival (OS), Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan, Trough Concentration (Ctrough) of Patritumab Deruxtecan

Interventions

DRUGMK-1022

DRUG-

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Dose-Escalation Phase), Number of Participants with One or More Adverse Events (AEs), Number of Participants who Discontinue Study Intervention Due to an AE, Objective Response Rate (ORR)	—

Secondary

Measure	Time frame
Duration of Response (DOR), Progression Free Survival (PFS), Overall Survival (OS), Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan, Trough Concentration (Ctrough) of Patritumab Deruxtecan	—

Countries

France, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026