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Clinical Trials List

Protocol NumberMK-1022-011

NCT Number(ClinicalTrials.gov Identfier)NCT06596694

Active

2024-10-01 - 2032-12-31

Phase I/II

Recruiting3

ICD-10C16.9

Malignant neoplasm of stomach, unspecified

ICD-10C7A.092

Malignant carcinoid tumor of the stomach

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9151.9

Malignant neoplasm of stomach, unspecified

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

Trial Applicant

Merck Sharp & Dohme (I.A.) LLC
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/06/17

Investigators and Locations

Principal Investigator Chih-Hung Hsu 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Huang Chen 無

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Jui Yen

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Gastrointestinal Cancer

Objectives

Primary Objectives: (1) To assess the confirmed objective response rate (ORR) by blinded independent central review (BICR) according to the Recist Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST 1.1) (in cohorts 1, 2, and cohort 3, subjects receiving the initially recommended phase 2 dose [RP2D]) (2) To evaluate the safety and tolerability of patritumab deruxtecan (HER3-DXd).

Test Drug

Injectable

Active Ingredient

HER3 directed ADC comprising a fully human anti-HER3 IgG1 patritumab, includes a topoisomerase I inhibitor payload (DXd MAAA-1181a)

Dosage Form

270

Dosage

100mg

Endpoints

Inclution 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

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 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

The Estimated Number of Participants

Taiwan

9 participants
Global

180 participants