A clinical study of raludotatug deruxtecan in people with gastrointestinal cancers (MK-5909-005)

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

31 Mar 2025 → ongoing

Decision date (initial)

2025-03-27

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

2024-517416-30-00

WHO UTN

U1111-1312-2472

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Pharmacogenomic, Therapy, Efficacy, Pharmacokinetic, Pharmacogenetic, Safety, Diagnosis, Prophylaxis, Pharmacoeconomic

1. To evaluate the confirmed ORR per RECIST 1.1 as assessed by BICR

Secondary objectives 4

1. To evaluate the safety and tolerability of R-DXd
2. To evaluate the DOR per RECIST 1.1 as assessed by BICR
3. To evaluate PFS per RECIST 1.1 as assessed by BICR
4. To evaluate OS

Conditions and MedDRA coding

Gastrointestinal Cancers

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Has one of the following cancers: • Unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC); • Unresectable or metastatic adenocarcinoma of the biliary tract [intra- or extrahepatic cholangiocarcinoma (CCA) or gallbladder cancer (GBC)]; • Unresectable or metastatic colorectal adenocarcinoma; • unresectable or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma (GEJAC), or esophageal adenocarcinoma (EAC)
2. Has received prior therapy for the cancer
3. Has a life expectancy of at least 3 months

Exclusion criteria 6

1. Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids or has current ILD/pneumonitis, and/or suspected ILD/pneumonitis
2. Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
3. Has uncontrolled or significant cardiovascular disease
4. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
5. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
6. Has not adequately recovered from major surgery or has ongoing surgical complications

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Objective Response Rate (ORR)

Secondary endpoints 5

1. Number of Participants who Experience One or More Adverse Events (AEs)
2. Number of Participants who Discontinue Study Treatment due to an AE
3. Duration of Response (DOR)
4. Progression Free Survival (PFS)
5. Overall Survival (OS)

Investigational products

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

Test 1

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

Ken Hatogai

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Ken Hatogai

Third parties 7

Locations

2 EU/EEA countries · 9 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 14 files

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

Application history

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