Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TGI-5 · 1 trial · 4 indications
The incidence of DLTs during the DLT assessment period
The incidences and percentages of patients experiencing AEs summarized by NCI CTCAE version 5.0 grade and by causality.
| Arm | Type | Description |
|---|---|---|
| Dose escalation of TGI-5 as monotherapy，Dose Escalation of TGI-5 in Combination with Nivolumab | EXPERIMENTAL | At the Phase 1a of this study, 0.01 mg/kg is proposed as the starting dose of TGI-5 as monotherapy for the FIH study. An accelerate titration and then traditional "3+3" dose escalation design will be used to explore the maximum tolerated dose (MTD)/optimal biological dose (OBD). Subjects will receive TGI-5 at the assigned dose regimen in combination with a fixed dose of Nivolumab (240 mg, IV infusion) Q2W, and the DLT assessment will be conducted in the subjects during the DLT evaluation period (Cycle 1). |
| Name | Type | Description |
|---|---|---|
| TGI-5 | DRUG | Subjects will receive TGI-5 as monotherapy in Phase 1a by Q2W for 28-day cycles. Subjects will receive TGI-5 in combination with Nivolumab in Phase 1b by Q2W for 28-day cycles. |
Inclusion Criteria: * 1\. Male or female subject age ≥18 years at the time of informed consent. 2. Phase 1a and dose escalation part of Phase 1b: Subjects with histologically or cytologically diagnosed unresectable locally advanced/metastatic solid tumors, mainly but not limited to CRC, HCC, melano...
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TGI-5 is an investigational small molecule being developed for the treatment of colorectal cancer (CRC). It is also being studied in other solid tumors, including melanoma, hepatocellular carcinoma (HCC), and non-small cell lung cancer (NSCLC). The drug is currently in Phase 1 clinical development.
TGI-5 is a small molecule oncology drug. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being evaluated as a monotherapy and in combination with nivolumab in patients with locally advanced or metastatic solid tumors.
TGI-5 is being developed by TG Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol TGTX. The company is conducting a Phase 1 clinical trial of TGI-5 in patients with advanced solid tumors.
TGI-5 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 study is recruiting patients with locally advanced or metastatic solid tumors, including colorectal cancer.
TGI-5 is being studied in a Phase 1 clinical trial registered as NCT07376707. This open-label, uncontrolled study evaluates TGI-5 as a monotherapy and in combination with nivolumab in patients with locally advanced or metastatic solid tumors. The trial is recruiting participants in China and aims to enroll 194 patients.
Yes, TGI-5 is being evaluated both as a monotherapy and in combination with nivolumab, an immune checkpoint inhibitor. The Phase 1 trial NCT07376707 is assessing this combination in patients with advanced solid tumors, including colorectal cancer, melanoma, hepatocellular carcinoma, and non-small cell lung cancer.