Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK5460025 · 1 trial · 2 indications
ORR is defined as percentage of participants with confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) by investigator assessment.
| Arm | Type | Description |
|---|---|---|
| Part 1: Dose escalation of GSK5460025 monotherapy | EXPERIMENTAL | Participants will receive GSK5460025 as monotherapy. |
| Part 2: Dose expansion of GSK5460025 monotherapy | EXPERIMENTAL | Participants will receive GSK5460025 as monotherapy. |
| Name | Type | Description |
|---|---|---|
| GSK5460025 | DRUG | GSK5460025 will be administered |
Inclusion Criteria: * Has a histologically diagnosed advanced (unresectable, metastatic or recurrent) solid tumor * Has a known dMMR/MSI-H status as determined by a certified local laboratory at the time of Pre-screening or has an unknown Mismatch repair (MMR)/ Microsatellite Instability (MSI) stat...
GSK5460025 is an investigational small molecule oncology drug being developed by GSK plc. It is in Phase 1 clinical development for the treatment of solid tumors, including neoplasms and colorectal cancer. It is not yet approved for any indication and remains under study in a single recruiting trial.
GSK5460025 is being studied for the treatment of solid tumors, specifically neoplasms and colorectal cancer. It is an investigational therapy in Phase 1 development, so it is not approved for any use. The ongoing trial enrolls adults aged 18 years and older with these tumor types.
GSK5460025 is developed by GSK plc, which trades under the ticker GSK. The company is the sponsor of the Phase 1 trial evaluating the drug in solid tumors, including colorectal cancer, across sites in the United States, Canada, Europe, and Japan.
GSK5460025 is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA or any other regulatory agency. The single Phase 1 trial is currently recruiting participants with solid tumors, including colorectal cancer.
GSK5460025 is being evaluated in one Phase 1 trial, NCT07213609, titled a study to investigate the safety and preliminary efficacy of GSK5460025 alone or in combination with other anti-cancer agents in participants with solid tumors. The trial is recruiting, with an estimated enrollment of 47 participants across nine countries.
Yes, the GSK5460025 Phase 1 trial NCT07213609 is biomarker selected, meaning enrollment is guided by a biomarker. The study is a controlled, non-randomized, open-label trial evaluating the drug alone or in combination with other anti-cancer agents in adults with solid tumors, including colorectal cancer.