Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as TGI-6 Injection
TGI-6 · 1 trial · 1 indication
The incidence of DLTs during the DLT assessment period.
Determination of the MTD or maximum tested dose, and the RP2D.
The incidences and percentages of patients experiencing AEs summarized by NCI CTCAE version 5.0 grade and by causality.
| Arm | Type | Description |
|---|---|---|
| TGI-6 Injection | EXPERIMENTAL | TGI-6 monotherapy dose escalation(Phase 1a) . TGI-6 monotherapy dose expansion(Phase 1b) . |
| Name | Type | Description |
|---|---|---|
| TGI-6 Injection | DRUG | TGI-6 will be administered intravenously at a dose and schedule as specified for the respective study part and cohort. |
Inclusion Criteria: 1. Male or female subjects age ≥18 years at the time of informed consent. 2. Phase 1a: Subjects with histologically or cytologically diagnosed unresectable locally advanced/metastatic CRC. Or subjects with confirmed B7-H6-positive unresectable locally advanced/metastatic solid t...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
TGI-6 is an investigational small molecule being developed for the treatment of advanced or metastatic solid tumors. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with locally advanced or metastatic solid tumors.
TGI-6 targets B7-H6 and CD3. B7-H6 is a protein expressed on tumor cells, while CD3 is a component of the T-cell receptor complex. By engaging both targets, TGI-6 is designed to bridge tumor cells and T cells, potentially directing the immune system to attack cancer cells.
TGI-6 is being developed by TG Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TGTX. The company is conducting clinical trials for this investigational drug candidate in the oncology therapeutic area.
TGI-6 is currently in Phase 1 clinical development. It is an investigational drug and has not yet received FDA approval. The ongoing Phase 1 trial is recruiting participants to evaluate the safety, tolerability, and preliminary efficacy of TGI-6 in patients with advanced or metastatic solid tumors.
TGI-6 is being evaluated in a single Phase 1 clinical trial registered as NCT06374173. This open-label, uncontrolled study is recruiting approximately 123 participants in China with locally advanced or metastatic solid tumors. The trial is actively enrolling adult patients of all sexes aged 18 years and older.
Yes, TGI-6 is also known as TGI-6 Injection. Both names refer to the same investigational drug product being developed by TG Therapeutics, Inc. for the treatment of advanced or metastatic solid tumors.