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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05985655 | Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors | PHASE1 | RECRUITING | 230 | — | — | Jul 6, 2023 | May 1, 2028 | Apr 23, 2026 | 13 | United States, Belgium +1 |
| Arm | Type | Description |
|---|---|---|
| Phase 1: Dose Escalation Monotherapy | EXPERIMENTAL | Participants will receive GTAEXS617 oral tablets in increasing doses. |
| Phase 1: Dose Escalation Combination Therapy | EXPERIMENTAL | Participants will receive GTAEXS617 oral tablets in increasing doses in combination with standard of care (SoC) treatment. |
| Phase 2: Dose Expansion Monotherapy | EXPERIMENTAL | Participants will receive GTAEXS617 oral tablets at Recommended Phase 2 Dose (RP2D). |
| Phase 2: Dose Expansion Combination Therapy | EXPERIMENTAL | Participants will receive GTAEXS617 oral tablets at RP2D in combination with SoC treatment. |
| Name | Type | Description |
|---|---|---|
| GTAEXS617 | DRUG | Administered as specified in the treatment arm. |
| SoC | DRUG | Participants will receive selected SoC regimen (fulvestrant, paclitaxel + bevacizumab, pegylated liposomal doxorubicin, or capecitabine) administered as specified in the treatment arm. |
Key Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Life expectancy \> 3 months. * One of the following histologically or cytologically confirmed advanced solid tumors: head and neck squamous cell carcinoma (HNSCC), pancreatic adenocarcinoma, non-small cell...