SHR-A2102 Clinical ADC

Antibody Information

Entry ID	1284
INN	None
Status	Clinical
Drug code(s)	SHR-A2102
Brand name	None
mAb sequence source	mAb humanized
General Molecular Category	ADC
Format, general category	TBD
Format details	TBD
Isotype (Fc)	TBD
Light chain isotype	TBD
Linker	None
Ave. DAR	None
Conjugated/fused moiety	Topoisomerase I inhibitor
Discovery method/technology	None

Therapeutic information

Target(s)	Nectin-4
Indications of clinical studies	Non-small cell lung cancer, Esophageal Cancer, Solid 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 3
Status	Active
Start of clinical phase (IND filing or first Phase 1)	June 15, 2022
Start of Phase 2	June 15, 2024
Start of Phase 3	February 12, 2025
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	Shanghai Hengrui Pharmaceutical Co. Ltd.
Licensee/Partner	None
Comments about company or candidate	NCT06738251 (CTR20244748) Phase 3 in Advanced Urothelial Carcinoma started in Feb 2025 NCT06654440 Phase 2 in Gynecological Malignancy started in Nov 2024. NCT06639347 Phase 1/2 in urothelial cancer due to start in Oct 2024. NCT06512051 Phase 1/2 in NSCLC due to start in July 2024 NCT06474468 Phase 1/2 in Esophageal Cancer started in June 2024 NCT06417554 /CTR20241520 Phase 1/2 due to start in May 2024 NCT05735275 Phase 1 started in Mar 2023 NCT05701709 is an Open-Label, Single-Arm, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of SHR-A2102 in Patients With Advanced Solid Tumors. On June 23 2022, Hengrui Medicine's clinical trial application for SHR-A2102 injection was accepted by NMPA.
Full address of company	Jiangsu, China Asia China https://www.hengrui.com/en/index.html

Description/comment

SHR-A2102 is a novel ADC comprised of a fully humanized IgG1 mAb against nectin-4, a cleavable linker, and a topoisomerase I inhibitor payload. (https://www.annalsofoncology.org/article/S0923-7534(24)02234-8/fulltext)

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None