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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07383506 | A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors | PHASE1 | RECRUITING | 90 | — | — | Jun 1, 2026 | Aug 1, 2029 | Jun 5, 2026 | 2 | United States |
Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) and AEs leading to dose modifications and dose limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD) or the maximum evaluated dose (MED) of CGT6297 in participants with advanced solid tumors harboring PIK3CA mutations
Overall Response Rate (ORR), as determined by CR + PR based on Investigator assessment using RECIST v1.1
| Arm | Type | Description |
|---|---|---|
| Dose Escalation | EXPERIMENTAL | Part 1a: Dose Escalation of Multiple doses of CGT6297 for oral administration |
| Signal Seeking | EXPERIMENTAL | Phase 1b: Participants will receive CGT6297 at a dose level selected based on data from Phase 1a |
| Name | Type | Description |
|---|---|---|
| CGT6297 | DRUG | CGT6297 Daily Oral Administration |
Inclusion Criteria: 1. Histologically confirmed advanced solid tumor harboring oncogenic PIK3CA mutations in blood and/or tumor: 1. Phase 1b Cohort 1, participants must have PIK3CA endometrial cancer 2. Phase 1b Cohort 2, participants must have HR-positive/HER2-negative or HER2-low breast ca...