​Clinical trial of patritumab deruxtecan in people with gastrointestinal cancers​

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

3 Dec 2024 → ongoing

Decision date (initial)

2024-11-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC · Daiichi Sankyo, Inc.

External identifiers

EU CT number

2024-512442-41-00

WHO UTN

U1111-1305-0677

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Pharmacodynamic, Therapy, Efficacy, Others

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)

Secondary objectives 4

1. To evaluate the DOR as assessed by BICR per RECIST 1.1 (Cohort 1, Cohort 2, Cohort 4, and participants who received the preliminary RP2D in Cohort 3)
2. To evaluate PFS as assessed by BICR per RECIST 1.1 (Cohort 1, Cohort 2, Cohort 4, and participants who received the preliminary RP2D in Cohort 3)
3. To evaluate OS (Cohort 1, Cohort 2, Cohort 4, and participants who received the preliminary RP2D in Cohort 3)
4. To characterize the PK of HER3-DXd (participants who received any dose of the study intervention in Cohort 3)

Conditions and MedDRA coding

Colorectal Carcinoma, Biliary Tract Carcinoma, Hepatocellular Carcinoma​

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. 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
2. Has received prior therapy for the cancer
3. Has recovered from any side effects due to previous cancer treatment

Exclusion criteria 6

1. 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
2. Has clinically severe respiratory compromise (based on the investigator’s assessment) resulting from intercurrent pulmonary illnesses
3. Has evidence of any leptomeningeal disease
4. Has clinically significant corneal disease
5. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
6. Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

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

Secondary endpoints 5

1. Duration of Response (DOR)
2. Progression Free Survival (PFS)
3. Overall Survival (OS)
4. Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan
5. Trough Concentration (Ctrough) of Patritumab Deruxtecan

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Johnathan Ebben

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Johnathan Ebben

Third parties 6

Locations

3 EU/EEA countries · 10 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 21 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications