Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK4418959 · 1 trial · 5 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 GSK4418959 monotherapy | EXPERIMENTAL | Participants will receive GSK4418959 as monotherapy. |
| Part 2: Dose expansion of GSK4418959 monotherapy | EXPERIMENTAL | Participants will receive GSK4418959 as monotherapy. |
| Part 3: Dose escalation of GSK4418959 plus PD-1 inhibitor | EXPERIMENTAL | Participants will receive GSK4418959 plus PD-1 inhibitor. |
| Name | Type | Description |
|---|---|---|
| GSK4418959 | DRUG | GSK4418959 will be administered. |
| PD-1 inhibitor | BIOLOGICAL | PD-1 inhibitor will be administered. |
Inclusion Criteria: Parts 1, 2, and 3 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)...
GSK4418959 is an investigational small molecule oncology drug being developed by GSK plc. It is being studied in a Phase 1 clinical trial in participants with solid tumors, including colorectal cancer, colon cancer, rectal cancer, and endometrial cancer. It has not been approved by the FDA and remains in clinical development.
GSK4418959 is being studied for the treatment of solid tumors, with the trial enrolling participants with neoplasms, colorectal cancer, solid tumors, colon cancer, rectal cancer, and endometrial cancer. It is an investigational therapy and is not approved for any indication. The study is biomarker-selected, meaning participants are chosen based on specific tumor characteristics.
GSK4418959 is developed by GSK plc, which trades under the ticker GSK. The company is sponsoring the Phase 1 clinical trial evaluating the drug in participants with solid tumors, including colorectal and endometrial cancers.
GSK4418959 is in Phase 1 clinical development. The single ongoing trial is currently active but not recruiting, with an enrollment of 14 participants. As an investigational drug, it has not received FDA approval and is still being evaluated for safety, pharmacokinetics, and preliminary effectiveness.
GSK4418959 is being evaluated in one Phase 1 trial, NCT06710847, titled a study to investigate the safety, pharmacokinetics, and preliminary effectiveness of GSK4418959 alone or in combination with other anti-cancer agents in participants with solid tumors. The trial is active but not recruiting and is being conducted in the United States, Australia, Belgium, Japan, the Netherlands, South Korea, and Spain.
Yes, the Phase 1 trial for GSK4418959 is biomarker-selected, meaning enrollment is restricted to participants whose tumors carry specific molecular characteristics. The study is evaluating the drug alone or in combination with other anti-cancer agents in adults with solid tumors, including colorectal and endometrial cancers.