Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04900818 | Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors | PHASE1 | RECRUITING | 330 | — | — | Jun 29, 2021 | Dec 1, 2027 | Mar 5, 2026 | 21 | United States, China |
The CTCAE criteria will be used to assess adverse events on this trial.
Based on DLT definitions
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| 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: Part 1 - Monotherapy Subjects with advanced or metastatic solid tumor in subjects whose disease has progressed despite standard therapy, or who has no further standard therapy, or who is unsuitable for available standard treatment options. Part 2 - Combination Therapy Subjects ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |