Last update 20 Mar 2025

Osemitamab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Claudin18.2 (CLDN18.2) humanized monoclonal antibody(MabSpace Biosciences (Suzhou) Co., Ltd.), Claudin18.2 monoclonal antibody, Claudin18.2 monoclonal antibody(Mabspace Biosciences)
+ [5]
Target
Action
inhibitors
Mechanism
CLDN18.2 inhibitors(Claudin 18.2 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Complement dependent cytotoxicity (CDC) effects
Inactive Indication-
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (United States)
Login to view timeline

Structure/Sequence

R&D Status

10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
CLDN18.2 positive Gastroesophageal junction adenocarcinomaPhase 3-31 Oct 2023
CLDN18.2 positive stomach adenocarcinomaPhase 3-31 Oct 2023
Gastroesophageal junction adenocarcinomaPhase 3
China
01 Sep 2023
Gastroesophageal junction adenocarcinomaPhase 3
South Korea
01 Sep 2023
Metastatic Solid TumorPhase 2
China
13 Aug 2020
Pancreatic Ductal AdenocarcinomaPhase 2
China
13 Aug 2020
Advanced cancerPhase 2
United States
28 May 2020
Advanced Malignant Solid NeoplasmPhase 2
United States
28 May 2020
Gastrooesophageal junction cancerPhase 2
United States
28 May 2020
Pancreatic CancerPhase 2
United States
28 May 2020
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
32
Osemitamab 3mnivolumabvolumab + CAPOX
(jbnjgbgkzq) = All patients experienced treatment-related adverse events (TRAE). The most common TRAE were hypoalbuminaemia, nausea and vomiting, most of them were of CTC AE grade 1 or 2 and manageable. uzyfibdvdj (zkqiwghwmq )
Positive
16 Sep 2024
Osemitamab 6mnivolumabvolumab + CAPOX
Phase 1/2
82
(erjxdnbocu) = exfnztdzvu fyeioerrqr (npgrieuyxx )
Positive
24 May 2024
Phase 1/2
248
(aznncmrukt) = Model simulated steady state trough concentration will achieve in vitro ADCC assay EC95 and in vivo MKN45-CLDN18.2 tumor growth inhibition model EC50 in most subjects following 6mg/kg Q3W and 4mg/kg Q2W. tmsmasiiev (odxfqvqgqv )
Positive
23 Oct 2023
Phase 1/2
64
(bpbnkmpsol) = nausea (70.3%), vomiting (53.1%) and hypoalbuminemia (75%) with grade 3 being 1.6% each zfaybgpdkt (pzmwskqvln )
Positive
23 Oct 2023
(6 mg/kg in the dose expansion phase)
Phase 1/2
Advanced cancer
First line
CLDN 18.2 Positive
64
(cocsuctzqs) = Most of them were grade 1 or 2, only one patient experienced grade 3 nausea and vomiting. mzvbjeforx (amsezqsbrm )
Positive
30 Jun 2023
Phase 1
Advanced cancer
First line
64
(jespgakuni) = Nausea (65.4%), vomiting (46.2%) and hypoalbuminemia (65.4%) were the most common adverse events related to TST001 at dose of 6mg/kg in 52 patients (3 patients in dose escalation and 49 patients in dose expansion), most of them were grade 1 or 2 (only one patient experienced grade 3 nausea and vomiting, and one experienced grade 3 hypoalbuminemia). bzzufhhqbp (yieshrxsuc )
Positive
26 May 2023
Phase 1
26
CAPOX+TST001
(surfjzylxl) = Most are grade 1-2, including nausea, hypoalbuminemia, anemia, vomiting, and elevated AST vgcxxsbvqe (jnbrjuevkh )
Positive
02 Jun 2022
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free