Raludotatug deruxtecan Clinical ADC

Antibody Information

Entry ID	577
INN	Raludotatug deruxtecan
Status	Clinical
Drug code(s)	DS-6000A, MK-5909
Brand name	None
mAb sequence source	mAb humanized
General Molecular Category	ADC
Format, general category	Full length Ab conjugate
Format details	None
Isotype (Fc)	IgG1
Light chain isotype	kappa
Linker	Glycine-Glycine-Phenylalanine-Glycine (GGFG; Cleavable linker)
Ave. DAR	~8 (Site-specific)
Conjugated/fused moiety	Topoisomerase I inhibitor, DXd/DX-8951 (MAAA-1181a)
Discovery method/technology	None

Therapeutic information

Target(s)	Cadherin-6
Indications of clinical studies	Gastrointestinal Cancer, Non-small cell lung cancer, Ovarian cancer, Phase 1 in Renal Cell Carcinoma and Ovarian Tumors
Primary therapeutic area	Cancer

Development stage information

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

Most advanced stage of development (global)	Phase 2/3
Status	Active
Start of clinical phase (IND filing or first Phase 1)	January 15, 2021
Start of Phase 2
Start of Phase 3	March 27, 2024
Date BLA/NDA submitted to FDA
Year of first approval (global)	None
Date of first US approval
INN, US product name	None
US or EU approved indications	None

Company information

Company	Daiichi Sankyo Co. Ltd
Licensee/Partner	Merck
Comments about company or candidate	NCT06780098 Phase 2 in NSCLC due to start in Feb 2025. NCT06161025 Phase 2/3 in ovarian cancer started in Feb 2024 October 19, 2023 I Daiichi Sankyo and Merck have entered into a global development and commercialization agreement for three of Daiichi Sankyo’s DXd antibody drug conjugate (ADC) candidates: patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd). NCT04707248 Phase 1 started in Jan 2021 still recruiting as of May 20, 2022.
Full address of company	Chuo City, Tokyo, Japan Asia Japan https://www.daiichisankyo.com/

Description/comment

Target is cadherin 6; DAR = 8 (https://www.daiichisankyo.com/files/investors/library/materials/2020/pdf/RD%20Day%202020_E.pdf); conjugated with deruxtecan, a camptothecin derivative

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None