Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06167317 | Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors | PHASE1 | RECRUITING | 278 | — | — | Jan 9, 2024 | Sep 1, 2028 | May 28, 2026 | 7 | United States, Israel |
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, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |