Overview

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Indication

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Research Report

Published: Jun 24, 2025

Raludotatug Deruxtecan (DS-6000): A Comprehensive Clinical and Scientific Review of a First-in-Class CDH6-Targeted Antibody-Drug Conjugate

I. Executive Summary

Raludotatug deruxtecan (R-DXd), also known by its development code DS-6000, is an investigational, potential first-in-class antibody-drug conjugate (ADC) representing a significant advancement in targeted oncology.[1] It is being jointly developed by Daiichi Sankyo and Merck & Co. (known as MSD outside the United States and Canada) to treat solid tumors that express Cadherin-6 (CDH6), a protein implicated in the progression and poor prognosis of cancers such as ovarian and renal cell carcinoma.[1]

The therapeutic is constructed on Daiichi Sankyo's clinically and commercially successful DXd ADC technology platform. This platform combines a humanized anti-CDH6 IgG1 monoclonal antibody (raludotatug) with a highly potent topoisomerase I inhibitor payload, deruxtecan (DXd), via a stable, tumor-selective, enzymatically cleavable linker.[1] A key feature of this design is a high drug-to-antibody ratio (DAR) of 8, which, combined with the membrane-permeable nature of the DXd payload, facilitates a powerful "bystander effect," enabling the destruction of adjacent tumor cells that may not express the target antigen.[6]

Clinical development is anchored by the first-in-human Phase 1 trial (NCT04707248), which has demonstrated compelling preliminary efficacy signals.[8] In a heavily pretreated cohort of patients with platinum-resistant ovarian cancer, a population with high unmet medical need, raludotatug deruxtecan achieved a confirmed objective response rate (ORR) of 46% and a median duration of response (DoR) of 11.2 months.[10] An even more pronounced ORR of 72.2% was observed in a smaller group of patients with platinum-sensitive ovarian cancer, suggesting potent activity.[12]

Continue reading the full research report

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003)	2025/02/25	NCT06843447	Phase 1	Recruiting	Merck Sharp & Dohme LLC
Substudy 01I: A Study of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01I/KEYMAKER-U01I)	2025/01/17	NCT06780098	Phase 2	Recruiting	Merck Sharp & Dohme LLC
A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)	2025/01/17	NCT06780085	Phase 2	Recruiting	Merck Sharp & Dohme LLC
A Study of Raludotatug Deruxtecan in Participants With Advanced/Metastatic Solid Tumors (REJOICE-PanTumor01)	2024/10/28	NCT06660654	Phase 2	Recruiting	Daiichi Sankyo
A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer	2023/12/07	NCT06161025	Phase 2	Recruiting	Daiichi Sankyo
Safety and Efficacy Study of Investigational Agents as Monotherapy or in Combination With Pembrolizumab (MK-3475) for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98)	2021/06/24	NCT04938817	Phase 1	Recruiting	Merck Sharp & Dohme LLC
A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors	2021/01/13	NCT04707248	Phase 1	Active, not recruiting	Daiichi Sankyo

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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