Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GNS561 · 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 is an investigational small molecule being studied for the treatment of cholangiocarcinoma, a cancer of the bile ducts. It is being evaluated specifically in patients with advanced KRAS mutated cholangiocarcinoma, in combination with trametinib. GNS561 is not approved and remains in clinical development.
GNS561 is being developed by Genfit SA, which trades on the NYSE under the ticker GNFT. The company sponsors the clinical program evaluating GNS561 in combination with trametinib for advanced KRAS mutated cholangiocarcinoma.
GNS561 is in Phase 1 clinical development. The program consists of a single active trial, and no trials have been completed. GNS561 is investigational and has not been approved by the FDA for any indication.
GNS561 is being studied in NCT05874414, titled Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated Cholangiocarcinoma. The Phase 1 trial is currently recruiting and plans to enroll 98 patients aged 18 years and older in the United States and Puerto Rico.
No. GNS561 is an investigational drug and has not been approved by the FDA. It is currently in Phase 1 clinical development for advanced KRAS mutated cholangiocarcinoma, and its only trial, NCT05874414, is still recruiting participants.