Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CTX-009 · 1 trial · 1 indication
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...
CTX-009 is an investigational small molecule being studied for the treatment of glioblastoma, a type of brain cancer. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being evaluated in patients with recurrent glioblastoma.
CTX-009 is a small molecule, but its specific molecular target has not been disclosed. The drug is being studied in a biomarker-selected patient population, suggesting that its mechanism of action may be linked to a particular biomarker. However, the exact target is not publicly available.
CTX-009 is being developed by COMPASS Pathways Plc, a biopharmaceutical company listed on the NASDAQ under the ticker symbol CMPS. The company is conducting clinical trials to evaluate the safety and efficacy of CTX-009 in patients with recurrent glioblastoma.
CTX-009 is currently in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 1 trial is designed to assess the safety and efficacy of CTX-009, with or without another investigational drug, CTX-471, in patients with recurrent glioblastoma.
CTX-009 is being studied in a Phase 1 clinical trial with the identifier NCT07392957. The trial, titled 'Safety and Efficacy of CTX-009 With or Without CTX-471 for Recurrent Glioblastoma,' is not yet recruiting and plans to enroll 54 participants in the United States. The study is controlled and randomized.
No, CTX-009 and CTX-471 are different investigational drugs. The Phase 1 clinical trial NCT07392957 is evaluating CTX-009 both alone and in combination with CTX-471 for the treatment of recurrent glioblastoma. CTX-009 is the primary drug being studied, while CTX-471 is an additional agent being tested in combination.