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: SHANGHAI F4 201210
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: China, United States
Active Clinical Trial Count: 2
Recent & Upcoming Milestones
- Clinical Outcomes Reported - I-Mab Biopharma presented P1 Gastrointestinal Cancer results on 2025-10-23 for Givastomig
- Clinical Outcomes Expected - I-Mab Biopharma announced they will present P1 Gastrointestinal Cancer results in 1Q26 for Givastomig
- Clinical Outcomes Reported - I-Mab Biopharma presented P1 Gastrointestinal Cancer results on 2025-07-02 for Givastomig
Highest Development Phases
Phase 1: Adenocarcinoma|Esophageal Cancer|Gastrointestinal Cancer|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 |
Gastrointestinal Cancer|Esophageal Cancer|Adenocarcinoma |
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 |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
12/10/2025 |
News Article |
NovaBridge Presents Positive Ragistomig Phase 1 Dose Expansion Data at ESMO-IO |
|
12/03/2025 |
News Article |
NovaBridge Announces Presentation of Ragistomig Expanded Phase 1 Data at ESMO-IO |
|
10/29/2025 |
News Article |
NovaBridge Subsidiary Visara Assigns Its Exclusive License to Everest Medicines for VIS-101 in Greater China and Certain Other Asian Countries |
|
10/22/2025 |
News Article |
I-Mab To Present Positive Updated Givastomig Monotherapy Data at 2025 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference on October 23, 2025 |
