Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GNS561+ Trametinib · 1 trial · 1 indication
Defined as Treatment Emergent Adverse Event (TEAE) being at least possibly related to study drug: With Grade ≥ 3 (using NCI CTCAE Version 5.0 or higher as applicable) such as specified in the protocol
Defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
| Arm | Type | Description |
|---|---|---|
| GNS561+Trametinib | EXPERIMENTAL | Phase 1b Dose Finding Patients will receive GNS561 (50mg QD; 100mg QD; 150mg; 200mg QD) and trametinib (2mg QD; 1.5mg QD; 1mg QD) in a dose escalation/de-escalation design to determine the maximum tolerated dose (MTD) of the combination. Experimental: Phase 2a Patients will receive GNS561 and trametinib at the recommended dose of the combination determined during Phase 1b |
| Name | Type | Description |
|---|---|---|
| GNS561 + Trametinib | DRUG | GNS561: 50mg, 100mg, 150mg, 200mg and trametinib: 1mg, 1.5mg and 2mg |
Inclusion criteria: 1. Histologically confirmed intrahepatic CCA with a documented KRAS mutation. 2. Patients greater than or equal to 18 years of age. 3. Patients must have disease progression that is not amenable to potentially curative treatment. 4. Patients must have received one or two lines o...
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GNS561 + Trametinib is an investigational combination therapy being studied for the treatment of cholangiocarcinoma, a type of bile duct cancer. It is specifically being evaluated in patients with advanced KRAS-mutated cholangiocarcinoma. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
GNS561 + Trametinib is a combination of two small molecules. Trametinib is a MEK inhibitor that targets the MAPK signaling pathway, which is often dysregulated in KRAS-mutated cancers. GNS561 is a small molecule that targets autophagy, a cellular process that cancer cells rely on for survival. The combination aims to inhibit tumor growth through these complementary mechanisms.
GNS561 + Trametinib is being developed by Genfit SA, a biopharmaceutical company listed on the stock exchange under the ticker symbol GNFT. The company is conducting clinical trials to evaluate the safety and efficacy of this combination therapy in patients with advanced cholangiocarcinoma.
GNS561 + Trametinib is currently in Phase 1 clinical development. The drug is investigational and has not been approved by the FDA or any other regulatory agency. It is being studied in a Phase 1 trial that is actively recruiting participants to assess the safety, tolerability, and preliminary efficacy of the combination.
GNS561 + Trametinib is being studied in a Phase 1 clinical trial with the identifier NCT05874414. This trial is titled 'Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated Cholangiocarcinoma' and is currently recruiting participants in the United States and Puerto Rico. The trial is an uncontrolled, open-label study with an estimated enrollment of 98 patients.
Yes, GNS561 + Trametinib is the same as GNS561 + Trametinib. The drug is a combination therapy consisting of two active pharmaceutical ingredients, GNS561 and trametinib. It is being investigated for the treatment of advanced KRAS-mutated cholangiocarcinoma in a Phase 1 clinical trial.