Telisotuzumab adizutecan Clinical ADC

Antibody Information

Entry ID	200
INN	Telisotuzumab adizutecan
Status	Clinical
Drug code(s)	ABBV-400
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	Valine-Alanine
Ave. DAR	___
Conjugated/fused moiety	Topoisomerase I inhibitor
Discovery method/technology	None

Therapeutic information

Target(s)	cMET
Indications of clinical studies	Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma, Colorectal cancer, Solid tumors, Non-small cell lung cancer
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)	September 01, 2021
Start of Phase 2
Start of Phase 3
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	Pierre Fabre
Licensee/Partner	AbbVie
Comments about company or candidate	NCT06614192 Phase 3 in colorectal cancer due to start in Nov 2024. NCT06107413 Phase 2 in colorectal cancer started in Nov 2023 NCT06084481 Phase 1 in solid tumors due to start in Nov 2023. NCT05029882 is a Phase 1 Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Non-Small Cell Lung Cancer Receiving Intravenous (IV) ABBV-400 results published (Doi: 10.1200/JCO.2023.41.16_suppl.3015).
Full address of company	Paris, France Europe France https://www.pierre-fabre.com/en-us

Description/comment

ABBV-400 is c-Met ADC that utilizes a topoisomerase inhibitor payload; cMet is also known as hepatocyte growth factor receptor.
Antibody described in "A novel antagonist anti-cMet antibody with antitumor activities targeting both ligand-dependent and ligand-independent c-Met receptors" (DOI: 10.1002/ijc.30174)

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None