Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TVB-2640 · 4 trials · 4 indications
Histological improvement is defined as ≥2 points improvement in NAS with ≥1 point improvement in ballooning or inflammation
NASH resolution defined as absence of fatty liver disease or isolated or simple steatosis without steatohepatitis and a score of either 0 or 1 for inflammation, 0 for ballooning and any value for steatosis and no worsening of liver fibrosis (by NASH CRN fibrosis score). Histological improvement defined as ≥2 point improvement in NAS (with ≥1 point improvement in ballooning or inflammation).
Determine Disease control rate of TVB-2640 in KRAS mutant NSCLC patients through RECIST and toxicity profile. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), \>=20% increase in the sum of diameters of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Determine response rate of TVB-2640 in KRAS mutant NSCLC patients through RECIST and toxicity profile. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), \>=20% increase in the sum of diameters of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
As determined by MRI-PDFF
Toxicity will be monitored according to NCI - Common Toxicity Criteria for Adverse Events version (4.03). Patients receiving at least one dose of drug.
| Arm | Type | Description |
|---|---|---|
| TVB-2640 50 mg | EXPERIMENTAL | Subjects will receive TVB-2640 PO QD for 52 weeks, with the first dose administered on Day 1. |
| Placebo | PLACEBO_COMPARATOR | Subjects will receive matching placebo PO QD for 52 weeks, with the first dose administered on Day 1. |
| TVB-2640 | EXPERIMENTAL | Patients will be administered TVB-2640 100mg/m2 orally once a day for 8 weeks. |
| TVB-2640 25 mg (US) | EXPERIMENTAL | Subjects randomly assigned to receive the study drug will take TVB-2640 tablet orally every day for 12 week treatment period. The dose is to be taken at the same time of the day, with each dose separated by 24 hours (±4 hours). |
| TVB-2640 50 mg (US) | EXPERIMENTAL | Subjects randomly assigned to receive the study drug will take TVB-2640 tablet orally every day for 12 week treatment period. The dose is to be taken at the same time of the day, with each dose separated by 24 hours (±4 hours). |
| Placebo (US) | PLACEBO_COMPARATOR | Subjects randomly assigned to placebo will receive placebo tablets orally once a day under the same conditions and frequency as described for TVB-2640. |
| TVB-2640 50 mg (China) | EXPERIMENTAL | Subjects randomly assigned to receive the study drug will take TVB-2640 tablet orally every day for 12 week treatment period. The dose is to be taken at the same time of the day, with each dose separated by 24 hours (±4 hours). |
| Placebo (China) | PLACEBO_COMPARATOR | Subjects randomly assigned to placebo will receive placebo tablets orally once a day under the same conditions and frequency as described for TVB-2640. |
| TVB-2640 75 mg (US) | EXPERIMENTAL | After completion of Cohorts 1 and 2, and if no stopping criteria are met upon review by the Independent SRC, an additional TVB-2640 75 mg open-label Cohort 3 will open in the US |
| Name | Type | Description |
|---|---|---|
| TVB-2640 | DRUG | Oral dose, tablet |
| Placebo | OTHER | Oral dose, tablet |
| TVB-2640 25 mg (US) | DRUG | Oral dose, tablet, daily dosing |
| TVB-2640 50 mg (US) | DRUG | Oral dose, tablet, daily dosing |
| Placebo (US) | DRUG | Oral dose, tablet, daily dosing |
| TVB-2640 50 mg (China) | DRUG | Oral dose, tablet, daily dosing |
| Placebo (China) | DRUG | Oral dose, tablet, daily dosing |
| TVB-2640 75 mg (US) | DRUG | Oral dose, tablet, daily dosing |
Inclusion Criteria: * Must be willing and able to participate in the study and provide written informed consent. * Male and female adults ≥18 years of age on the date that written informed consent to take part in the study is provided. * Body mass index (BMI) ≥23 kg/m2 for Asians and ≥25 kg/m2 for ...
TVB-2640 is an investigational small molecule being studied for MASLD/MASH, solid malignant tumors, KRAS gene mutation, and non-alcoholic steatohepatitis. It is in clinical development for these conditions, including a Phase 1 study in solid tumors and Phase 2 studies in KRAS non-small cell lung carcinomas and NASH.
TVB-2640 targets FASN, an enzyme involved in fatty acid synthesis. By inhibiting FASN, the drug aims to affect metabolic pathways relevant to diseases like MASH and certain cancers. This mechanism is being evaluated in clinical trials for solid tumors, KRAS-mutant lung cancer, and non-alcoholic steatohepatitis.
TVB-2640 is being developed by Sagimet Biosciences Inc., a company listed on the stock exchange under the ticker SGMT. The company is conducting clinical trials for this investigational drug across multiple indications, including MASH and solid tumors.
TVB-2640 is in Phase 1 and Phase 2 clinical trials. It has completed Phase 1 studies in solid tumors and hepatic impairment, and Phase 2 studies in KRAS non-small cell lung carcinomas and non-alcoholic steatohepatitis. It is investigational and not yet approved by the FDA.
TVB-2640 has been studied in several clinical trials, including NCT02223247 (Phase 1 in solid tumors), NCT03808558 (Phase 2 in KRAS non-small cell lung carcinomas), NCT03938246 (Phase 2 in NASH), and NCT05835180 (Phase 1 in hepatic impairment). These trials are completed or active.
Yes, TVB-2640 is also known as Denifanstat. The drug is referred to by both names in clinical research, including in a Phase 1 pharmacokinetic study of TVB-2640 (Denifanstat) in subjects with hepatic impairment.