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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06532565 | Study of GS-2121 Given Alone or in Combination in Adults With Advanced Solid Tumors | PHASE1 | RECRUITING | 154 | — | — | Jul 26, 2024 | Jun 1, 2028 | Apr 21, 2026 | 6 | United States, Canada |
DLTs are defined as any of the protocol-specified treatment-emergent adverse events (AEs) with onset within the DLT-evaluation period for the corresponding dose.
DLTs are defined as any of the protocol-specified treatment-emergent adverse events (AEs) with onset within the DLT-evaluation period for the corresponding dose.
| Arm | Type | Description |
|---|---|---|
| Part A: GS-2121 Monotherapy Dose Escalation | EXPERIMENTAL | Participants will receive escalating doses of GS-2121 monotherapy until disease progression, or until the participant meets other study drug discontinuation criteria as specified in protocol. |
| Part B: GS-2121 Monotherapy Dose Expansion | EXPERIMENTAL | Participants with selected indications will receive GS-2121 monotherapy at the recommended dose for expansion. |
| Part C: Combination Dose Escalation of GS-2121 with Zimberelimab | EXPERIMENTAL | Participants will receive escalating doses of GS-2121 in combination with zimberelimab until disease progression, or until the participant meets other study drug discontinuation criteria as specified in protocol. |
| Part D: Combination Dose Expansion of GS-2121 with Zimberelimab | EXPERIMENTAL | Participants with selected indications will receive GS-2121 at the recommended dose for expansion in combination with zimberelimab. |
| Name | Type | Description |
|---|---|---|
| GS-2121 | DRUG | Tablet administered orally |
| Zimberelimab | DRUG | Administered intravenously |
Key Inclusion Criteria: * Participants diagnosed with histologically or cytologically confirmed advanced solid tumors who have progressed despite standard therapy, are intolerant to standard therapy, or are ineligible for standard therapy. * Measurable disease per Response Evaluation Criteria in So...
| 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 |