Ozmosi | Givastomig Drug Profile
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Givastomig

Pronounced as: jiv-ah-STOH-mig

Alternative Names: Givastomig, TJ-CD4B, ABL111, ABL-111, ABL 111, tj-033721, tj 033721, tj033721
Clinical Status: Active
Latest Update: 2026-02-25
Latest Update Note: Clinical Trial Update

Product Description

A bispecific antibody composed of a human, Fc-silenced immunoglobulin G1 (IgG1) monoclonal antibody targeting the tumor-associated antigen (TAA) Claudin18.2 (CLDN18.2; A2 isoform of claudin-18) fused with a single chain variable fragment (scFv) targeting 4-1BB (CD137; tumor necrosis factor receptor superfamily member 9; TNFRSF9), with potential immunostimulating and antineoplastic activities. Upon administration, anti-CLDN18.2/anti-4-1BB bispecific antibody TJ-CD4B simultaneously targets and binds to CLDN18.2 expressed on tumor cells and 4-1BB expressed on a variety of leukocyte subsets including activated T lymphocytes. Upon CLDN18.2 binding, the 4-1BB activation signal is induced and TJ-CD4B acts as a conditional 4-1BB agonist in the tumor microenvironment (TME), resulting in T-cell co-stimulation and T-lymphocyte-mediated anti-tumor activity. CLDN18.2, a tight junction protein and stomach-specific isoform of claudin-18, is expressed on a variety of tumor cells. Its expression in healthy tissues is strictly confined to short-lived differentiated epithelial cells of the gastric mucosa. 4-1BB, a surface glycoprotein of the tumor necrosis factor receptor superfamily, is an inducible costimulatory receptor that plays a key role in T-cell proliferation, survival and cytolytic activity. (Sourced from: https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-claudin182-anti-4-1bb-bispecific-antibody-tj-cd4b)

Mechanisms of Action: CLDN18.2 Inhibitor, 4-1BB Inhibitor

Novel Mechanism: Yes

Modality: Bispecific Antibody

Route of Administration: Intravenous

FDA Designation: Orphan Drug - Gastrointestinal Cancer *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: I-Mab Biopharma
Company Location:
Company Founding Year: 2016
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Givastomig

Countries in Clinic: China, United States

Active Clinical Trial Count: 3

Recent & Upcoming Milestones

  • Clinical Outcomes Expected - NovaBridge announced they will present P2 Gastrointestinal Cancer results in YE27 for Givastomig
  • Clinical Outcomes Reported - NovaBridge presented P1 Gastrointestinal Cancer results on 2026-01-06 for Givastomig
  • Clinical Trial Start Expected - NovaBridge announced they will initiate a P2 Gastrointestinal Cancer trial in 1Q26 for Givastomig

Highest Development Phases

Phase 2: Adenocarcinoma|Esophageal Cancer|Gastrointestinal Cancer

Phase 1: Oncology Solid Tumor Unspecified

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

NCT04900818

TJ033721STM101

P1

Recruiting

Esophageal Cancer|Adenocarcinoma|Gastrointestinal Cancer

2025-12-01

12%

2025-01-04

Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments

CTR20220747

CTR20220747

P1

Recruiting

Oncology Solid Tumor Unspecified

None

2025-04-29

Patient Enrollment|Start Date|Treatments|Trial Status

NCT07432295

GIVA-2

P2

Recruiting

Gastrointestinal Cancer|Adenocarcinoma|Esophageal Cancer

2030-03-01

12%

2026-02-26