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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 | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Givastomig is an investigational therapy being studied in adults with advanced or metastatic solid tumors, including gastric cancer, gastroesophageal junction carcinoma, esophageal adenocarcinoma, pancreatic ductal adenocarcinoma, and biliary tract cancer. It is being evaluated both as a single agent and in combination with nivolumab and chemotherapy in biomarker-selected patients whose tumors are CLDN18.2 positive.
Givastomig targets CLDN18.2, a protein expressed on certain tumor cells. By binding this target, the drug is designed to act on CLDN18.2 positive cancers. The clinical program selects patients based on CLDN18.2 status, and the Phase 2 study enrolls only those with CLDN18.2 positive metastatic gastric cancer.
Givastomig is being developed by NovaBridge Biosciences, which trades under the ticker NBP. The company is running the clinical program for the drug across sites in the United States, China, and Japan.
Givastomig is in Phase 2 development. It is an investigational drug and has not been approved by the FDA. The FDA has granted it Fast Track designation. Two trials are currently active and recruiting, with no completed trials reported to date.
Givastomig is being studied in two recruiting trials. NCT07432295, known as GIVA-2, is a Phase 2 study of givastomig combined with nivolumab and chemotherapy in adults with CLDN18.2 positive metastatic gastric cancer, enrolling 180 patients. NCT04900818 is a Phase 1 study in advanced or metastatic solid tumors, enrolling 330 patients.
Yes. Givastomig is also known as TJ033721. The two names refer to the same investigational compound, and the Phase 1 trial is listed under the designation TJ033721 (Givastomig). Searches for either name point to the same drug candidate from NovaBridge Biosciences.