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Also known as TJ033721 (givastomig), TJ033721
Givastomig · 2 trials · 8 indications
Compare PFS between participants receiving givastomig plus nivolumab and chemotherapy versus control (nivolumab plus chemotherapy)
Incidence, severity, and type of adverse events, including treatment-emergent and immune-related adverse events, graded by NCI CTCAE v5.0
The CTCAE criteria will be used to assess adverse events on this trial.
Based on DLT definitions
| Arm | Type | Description |
|---|---|---|
| Experimental: Givastomig Arm 1 Combination | EXPERIMENTAL | Givastomig (IV) 8 mg/kg every 2 weeks (Q2W) in combination with nivolumab and modified FOLFOX (mFOLFOX) or Givastomig 12 mg/kg every 3 weeks (Q3W) in combination with nivolumab and CAPOX |
| Experimental: Givastomig Arm 2 Combination | EXPERIMENTAL | Givastomig (IV) 12 mg/kg every 2 weeks (Q2W) in combination with nivolumab and modified FOLFOX (mFOLFOX) or Givastomig 18 mg/kg every 3 weeks (Q3W) in combination with nivolumab and CAPOX |
| Control: Nivolumab Plus Chemotherapy | ACTIVE_COMPARATOR | Nivolumab in combination with modified FOLFOX (mFOLFOX) or CAPOX |
| TJ033721 (givastomig) | EXPERIMENTAL | Dose Escalation: TJ033721 will be administered at up to 8 dose levels (0.1, 0.3, 1, 3, 5, 8, 12 and 15 mg/kg) bi weekly (Q2W) and 1 dose level (18 mg/kg) every 3 weeks (Q3W) During dose expansion, TJ033721 will be administered Q2W, starting at the RP2D or MTD in dose escalation. |
| TJ033721 (givastomig) in combination with nivolumab and chemotherapy | EXPERIMENTAL | TJ033721 will be administered in combination with nivolumab and chemotherapy |
| TJ033721 (givastomig) in combination chemotherapy | EXPERIMENTAL | TJ033721 (givastomig) will be administered in combination chemotherapy |
| TJ033721 (givastomig) in combination with durvalumab and chemotherapy | EXPERIMENTAL | TJ033721 (givastomig) will be administered in combination with durvalumab and chemotherapy |
| Name | Type | Description |
|---|---|---|
| Givastomig | DRUG | Givastomig 8mg/kg Q2W IV or 12mg/kg Q3W IV |
| Nivolumab | DRUG | Q2 or Q3W IV |
| 5Fluorouracil | DRUG | Q2W IV |
| Leucovorin | DRUG | Q2W IV |
| Oxaliplatin | DRUG | Q2W or Q3W IV |
| Capecitabine | DRUG | Twice daily x 14 days every 3 weeks PO |
| TJ033721 (givastomig) | DRUG | Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb) |
| TJ033721 (givastomig) , nivolumab, chemotherapy | DRUG | Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), nivolumab, chemotherapy |
| TJ033721 (givastomig), chemotherapy | DRUG | Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), chemotherapy |
| TJ033721 (givastomig), durvalumab, chemotherapy | DRUG | Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), durvalumab, chemotherapy |
Inclusion Criteria: * Histologically confirmed unresectable, locally advanced, or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC). * Treatment-naïve for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy allowed if ≥6 months since last dose). * C...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Givastomig is an investigational small molecule being developed for the treatment of solid tumors, including advanced and metastatic cancers. It is specifically being studied in CLDN18.2 positive metastatic gastric cancer, gastroesophageal junction carcinoma, and esophageal adenocarcinoma. The drug is currently in Phase 2 clinical development.
Givastomig is being developed by I-Mab, a biopharmaceutical company listed as I-Mab Sponsored ADR under the ticker symbol NBP. The company is conducting clinical trials for this investigational oncology drug.
Givastomig is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug has received FDA designations including accelerated approval and fast track status for its development program.
Givastomig is being studied in a Phase 2 clinical trial with NCT number NCT07432295, titled 'Givastomig Combined With Nivolumab and Chemotherapy in Adults With CLDN18.2 Positive Metastatic Gastric Cancer (GIVA-2)'. The trial is actively recruiting 180 participants across the United States, China, and Japan.
No alternative names for Givastomig have been disclosed. The drug is identified solely by its generic name Givastomig in clinical trial registrations and development documentation.