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 | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
GS-0201 is an investigational small molecule being developed by Gilead Sciences for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and has not been approved by the FDA. The program is biomarker-selected, meaning trial enrollment is guided by a specific biomarker rather than an unselected patient population.
GS-0201 is being studied for use in advanced solid tumors, a broad category of cancers that have spread or cannot be removed surgically. It is an investigational therapy in Phase 1 testing, so it is not yet available as a treatment outside of clinical trials. The study enrolls adults 18 years and older.
GS-0201 is being developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. Gilead is the sponsor of the clinical program evaluating the compound in advanced solid tumors. No partner or co-development arrangement for GS-0201 is disclosed in the available program information.
GS-0201 is in Phase 1 clinical development. It is an investigational small molecule and is not FDA approved. The Phase 1 stage is designed primarily to assess safety, tolerability, and early activity in participants with advanced solid tumors before the program can advance to later-stage testing.
GS-0201 is being evaluated in one clinical trial, NCT06167317, titled Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors. The trial is currently recruiting, has a planned enrollment of 278 participants, and is being conducted in the United States and Israel. It is a controlled study and is not randomized or double blinded.
The Phase 1 trial NCT06167317 evaluates GS-0201 both as a single agent and in combination with other therapies in participants with advanced solid tumors. The study is controlled, is not randomized, and is not double blinded, and it is currently recruiting adults aged 18 years and older in the United States and Israel.