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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07392957 | Safety and Efficacy of CTX-009 With or Without CTX-471 for Recurrent Glioblastoma | PHASE1 | NOT YET_RECRUITING | 54 | — | — | Apr 30, 2026 | Apr 30, 2031 | Mar 23, 2026 | 1 | United States |
Adverse events will be graded according to CTCAE v5.0
RP2D will be determined from the phase IB portion of Arm 1 by assessing tolerability. Tolerability is defined as ≤1 among patients experiencing excessive dose limiting toxicities (DLTs). The dose level in phase IB determined to be tolerable is the RP2D.
Adverse events will be graded according to CTCAE v5.0
Overall survival is defined from time of treatment start to time of death due to any cause or latest follow-up, whichever is earlier, with an inference focus on 12-month overall survival.
Overall survival is defined from time of treatment start to time of death due to any cause or latest follow-up, whichever is earlier, with an inference focus on 12-month overall survival.
| Arm | Type | Description |
|---|---|---|
| Phase IB Arm 1: CTX-009 monotherapy | EXPERIMENTAL | CTX-009 will be given intravenously at the assigned dose level on an outpatient basis every 2 weeks of a 28-day cycle. |
| Phase IB Arm 2: CTX-009 and CTX-471 combination therapy | EXPERIMENTAL | CTX-009 will be given intravenously at the dose determined to be the recommended phase II dose (RP2D) in Arm 1 every 2 weeks, and CTX-471 will be given intravenously at a dose of 0.3 mg/kg every 2 weeks (day 1 and day 15). On days when both drugs are given, CTX-009 will be given first, followed by a 30-minute observation period, followed by CTX-471. Cycles will be 28 days. |
| Phase II Expansion Arm 1: CTX-009 monotherapy | EXPERIMENTAL | CTX-009 will be given intravenously at the recommended phase 2 dose (RP2D) determined from Phase IB on an outpatient basis every 2 weeks of a 28-day cycle. |
| Phase II Expansion Arm 2: CTX-009 and CTX-471 combination therapy | EXPERIMENTAL | CTX-009 will be given intravenously at the dose determined to be the recommended phase II dose (RP2D) every 2 weeks (day 1 and day 15). CTX-471 will be given intravenously at a dose of 0.3 mg/kg every 2 weeks (day 1 and day 15). On days when both drugs are given, CTX-009 will be given first, followed by a 30-minute observation period, followed by CTX-471. Cycles will be 28 days. |
| Name | Type | Description |
|---|---|---|
| CTX-009 | DRUG | CTX-009 will be given intravenously over the course of 60 minutes (+/- 5 minutes) on an outpatient basis every 2 weeks of a 28-day cycle. |
| CTX-471 | DRUG | CTX-471 will be given intravenously over the course of 30 minutes (-5/+10) on an outpatient basis every 2 weeks of a 28-day cycle. |
Inclusion Criteria: * Histologically or radiographically confirmed recurrent CNS WHO grade 4 IDH wild-type glioma following standard of care treatment including radiation, chemotherapy, and/or tumor-treating fields. No more than 2 recurrences are allowed. * At least 18 years of age. * KPS performan...