Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Tovecimig
CTX-009 · 4 trials · 9 indications
Defined as the proportion of patients who have a partial response (PR) or complete response (CR) per RECIST 1.1. CR is defined as disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Percentage of patients whose Best Overall Response (BOR) is assessed as Complete Response (CR) or Partial Response (PR) as assessed by RECIST 1.1
Percentage of patients whose best overall response is assessed as complete response (CR) or partial response (PR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: CR: disappearance of all target lesions; PR: \>=30% decrease in the sum of the longest diameter of target lesions.
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 |
|---|---|---|
| Tovecimig and Irinotecan + Leucovorin + 5-Fluorouracil (FOLFIRI regimen) | EXPERIMENTAL | Treatment will be administered in 28-day cycles. On Day 1 and 15 of each cycle, patients will receive Tovecimig followed by the FOLFIRI regimen. |
| CTX-009 plus Paclitaxel | EXPERIMENTAL | - |
| Paclitaxel | ACTIVE_COMPARATOR | Patients randomized to receive paclitaxel only have the option to crossover to the CTX-009 plus paclitaxel arm after documented disease progression per RECIST v1.1. |
| CTX-009 Treatment | EXPERIMENTAL | - |
| 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 |
|---|---|---|
| Tovecimig | BIOLOGICAL | Tovecimig is provided in 10 mg/kg dose intravenously over the course of 60 minutes on Day 1 and Day 15 of a 28-day cycle. |
| Irinotecan | DRUG | Standard of care irinotecan will be given at a dose of 180 mg/m\^2 intravenously on Day 1 and Day 15 of each 28-day cycle as part of the FOLFIRI treatment regimen. |
| Leucovorin | DRUG | Standard of care leucovorin will be given at a dose of 400 mg/m\^2 intravenously on Day 1 and Day 15 of each 28-day cycle as part of the FOLFIRI treatment regimen. |
| 5-Fluorouracil (5-FU) | DRUG | Standard of care 5-FU will be given at a dose of 2400 mg/m\^2 in continuous infusion over 46 hours on Days 1-2 and Days 15-16 of each 28-day cycle as part of the FOLFIRI treatment regimen. |
| CTX-009 | DRUG | IV infusion on day 1 and 14 of every 28 day cycle |
| Paclitaxel | DRUG | IV infusion on day 1, 8, and 15 of every 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 cytologically confirmed CRC. * Patient must have undergone resection of his/her primary tumor either as part of treatment for early stage disease with subsequent metastatic progression or due to a tumor related complication in the metastatic setting (e.g. bow...
CTX-009 is an investigational small molecule oncology drug being developed by Compass Therapeutics, Inc. It is designed to target the DLL4 and VEGF-A proteins and is being studied in biliary tract cancer, glioblastoma, and metastatic colorectal cancer. It is in Phase 2 clinical development and has received FDA Fast Track designation.
CTX-009 targets two proteins: DLL4 (Delta-like ligand 4) and VEGF-A (vascular endothelial growth factor A). By binding both targets, the drug is designed to interfere with the DLL4 and VEGF-A signaling pathways. It is being evaluated in biliary tract cancer, glioblastoma, and metastatic colorectal cancer.
CTX-009 is being studied in biliary tract cancer, including cholangiocarcinoma, gallbladder cancer, and ampullary cancer. The Phase 2 COMPANION-002 trial (NCT05506943) evaluates CTX-009 in combination with paclitaxel in adults with unresectable advanced, metastatic, or recurrent biliary tract cancers. That trial is active but not recruiting, with 168 patients enrolled.
CTX-009 is being developed by Compass Therapeutics, Inc., which trades on the Nasdaq under the ticker CMPX. The company is running clinical trials of CTX-009 across biliary tract cancer, glioblastoma, and metastatic colorectal cancer, including the Phase 2 COMPANION-002 study in biliary tract cancers.
CTX-009 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 2 COMPANION-002 trial in biliary tract cancer is active but not recruiting, and a Phase 1 glioblastoma trial is not yet recruiting. CTX-009 holds FDA Fast Track designation.
CTX-009 has been studied in three registered trials. NCT05506943 (COMPANION-002) is a Phase 2 trial in biliary tract cancers that is active but not recruiting. NCT05513742 is a completed Phase 2 trial in metastatic colorectal cancer. NCT07392957 is a Phase 1 glioblastoma trial that is not yet recruiting.