GAMSITABART TOCENTECAN
UNII 6P4HV3YR58

Substance Identification & Data

This profile provides standardized clinical and technical data for Gamsitabart Tocentecan, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 6P4HV3YR58.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 3040339-19-0 and the RxNorm Concept ID (RxCUI) N/A. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code

6P4HV3YR58

CAS Registry Number

3040339-19-0

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

GAMSITABART TOCENTECAN

Official standardized name for this substance within the FDA UNII nomenclature system.

INN ID

13909

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Gamsitabart Tocentecan

ISO 11238 classification category (e.g., Chemical, Polymer, Protein).

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Gamsitabart Tocentecan. Identifiers are organized into official regulatory terms, commercial trade names, and technical systematic synonyms used to ensure accurate identification across clinical pharmaceutical databases, regulatory filings, and electronic health records.

FDA Official Name

Gamsitabart Tocentecan

Common Names & Synonyms

An ADC consisting of antibody Hu14.18-IgG1.4(K322A)-delK conjugated to linker-payload βGluc Exatecan with a drug-to-antibody ratio of 8

H-gamma1 heavy chain (1-441) [VH Musmus/Homsap (Mus musculus IGHV1-42*04 (86.5%) -(IGHD) -IGHJ4*01 (92.9%)/Homo sapiens IGHV1-46*01 (71.9%) -(IGHD) -IGHJ5*01 (90.9%) L123>S (108), CDR-IMGT [8.8.6] (26-33.51-58.97-102)) (1-113) -Homo sapiens IGHG1*03, G1m3, nG1m1 CH1 R120, CH3 E12, M14, 1-G1v50 CH2 delE1.4 P1.3, V1.2, A1.1, 5-G1v20 CH2 A105, 6-G1v60 CH2 S115, S116 (CH1 R120 (210) (114-211), hinge 1-15 (212-226), CH2 E1.4>del, L1.3>P (229), L1.2>V (230), G1.1>A (231), K105>A (317), A115>S (325), P116>S (326) (227-335), CH3 E12 (351), M14 (353) (336-440), CHS K2>del (441)) (114-441)], (216-220')-disulfide with L-kappa light chain (1'-220') [V-KAPPA Musmus/Homsap (Mus musculus IGKV1-110*01 (94.0%) -IGKJ5*01 (100%)/Homo sapiens IGKV2D-29*02 (82.0%) -IGKJ2*01 (81.8%) Q120>A (106'), I126>L (112'), CDR-IMGT [11.3.10] (27'-37'.55'-57'.94'-103')) (1'-113') -Homo sapiens IGKC*01 (100%) Km3 A45.1, V101 (C-KAPPA A45.1 (159'), V101 (197')) (114'-220')]; dimer (222-222'':225-225'')-bisdisulfide, produced in Chinese hamster ovary (CHO) cells, cell line CHO-K1SV, glycoform alfa; substituted at the sulfur atoms of an average of eight L-cysteinyl residues among 216, 222, 225, 220', 216'', 222'', 225'' and 220''' with 1-{3-[(2-{5-[({[(1S,9S)-9-ethyl-5-fluoro-9-hydroxy-4-methyl-10,13-dioxo-2,3,9,10,13,15-hexahydro-1H,12H-benzo[de]pyrano[3',4':6,7]indolizino[1,2-b]quinolin-1-yl]carbamoyl}oxy)methyl]-2-(β- D -glucopyranuronosyloxy)anilino}-2-oxoethyl)amino]-3-oxopropyl}-2,5-dioxopyrrolidin-3-yl (tocentecan) groups

Hu 14.18-IgG1.4 (K322A)-delK-βGluc Exatecan

gamsitabart tocentecan [INN]

immunoglobulin G1-kappa, anti-[Homo sapiens GD2 (disialoganglioside GD2)], monoclonal antibody, conjugated on an average of eight cysteinyl residues to tocentecan, comprising a linker and a camptothecin derivative (exatecan) (gamsitabart tocentecan)

External Clinical & Regulatory Resources

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