Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GS-0201 · 1 trial · 1 indication
DLTs are defined as any of the following treatment-emergent adverse events (AEs) regardless of attribution (graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0), unless clearly related to an underlying disease or extraneous causes, with onset within the DLT-evaluation period for the corresponding dose.
| Arm | Type | Description |
|---|---|---|
| Part A: GS-0201 Monotherapy Dose Escalation | EXPERIMENTAL | Participants will receive escalating doses of GS-0201 monotherapy, until disease progression, or until the participant meets other study drug discontinuation criteria as specified in protocol or up to 105 weeks, whichever occurs first. |
| Part B: Cohort B1: GS-0201 Monotherapy Dose Expansion | EXPERIMENTAL | Participants with selected breast cancer indication will receive GS-0201 monotherapy at the recommended dose for expansion. |
| Part B: Cohort B2: GS-0201 Monotherapy Dose Expansion | EXPERIMENTAL | Participants with selected indications not included in cohort B1 will receive GS-0201 monotherapy at the recommended dose for expansion. |
| Part C: Dose Escalation: GS-0201 + Sacituzumab Govitecan (SG) | EXPERIMENTAL | Participants will receive escalating doses of GS-0201 in combination with SG, until disease progression, or until the participant meets other study drug discontinuation criteria as specified in protocol or up to 105 weeks, whichever occurs first. |
| Part D: Cohort D1: Dose Expansion: GS-0201 + SG | EXPERIMENTAL | Participants with confirmed unresectable locally advanced or metastatic triple negative breast cancer (mTNBC) will receive GS-0201 at the recommended Phase 2 dose (RP2D) in combination with SG. |
| Part D: Cohort D2: Dose Expansion: GS-0201 + SG | EXPERIMENTAL | Participants with recurrent/persistent endometrial cancer will receive GS-0201 at the recommended Phase 2 dose (RP2D) in combination with SG. |
| Name | Type | Description |
|---|---|---|
| GS-0201 | DRUG | Pill administered orally |
| Sacituzumab Govitecan | DRUG | Administered intravenously |
Inclusion Criteria: * Able to understand and give written informed consent. * Assigned female or male at birth, 18 years of age or older, and meet the age of majority/adulthood per local regulations. * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. * Measurable disease by Resp...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
GS-0201 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in patients.
GS-0201 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting a Phase 1 clinical trial of GS-0201 in patients with advanced solid tumors.
GS-0201 is in Phase 1 clinical development. It is an investigational drug, not yet approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is recruiting participants to evaluate the drug alone and in combination for advanced solid tumors.
GS-0201 is being studied in a single Phase 1 clinical trial with the identifier NCT06167317. This trial, titled "Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors," is currently recruiting participants in the United States and Israel, with a planned enrollment of 278 patients.
No, the Phase 1 clinical trial of GS-0201 is not randomized and not double-blind. It is a controlled study, meaning there is a control group, but participants are not randomly assigned to treatment arms, and the trial is not blinded.