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CTX-009

Phase 2

Biliary Tract Cancer | Small molecule | Oncology |Compass Therapeutics, Inc.|Last Updated: Sep 2, 2026

Target and mechanism

Molecular targetDLL4, VEGF-A
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment168

FDA Designations

FAST_TRACK

Clinical trial landscape

CTX-009 · 2 trials · 7 indications

Phase 2 2
NCT05506943A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)Biliary Tract Cancer
ACTIVE NOT_RECRUITING168 Analytics
NCT05513742A Study of CTX-009 in Adult Patients With Metastatic Colorectal CancerMetastatic Colorectal Cancer
COMPLETED49 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract CancerUnlock trial analytics
PHASE2COMPLETED
A Study of CTX-009 in Adult Patients With Metastatic Colorectal Cancer
Metastatic Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Best Overall Response
From randomization to treatment discontinuation for any reason, average 6 months

Percentage of patients whose Best Overall Response (BOR) is assessed as Complete Response (CR) or Partial Response (PR) as assessed by RECIST 1.1

Overall Response Rate
From first dose of CTX-009 until treatment discontinuation (an average of 16 weeks)

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.

Secondary Endpoints

Progression Free Survival
From randomization to first documented objective PD or death if PD does not occur, average 6 months
Duration of Response
From first confirmed CR or PR to confirmed PD, average 6 months
Overall Survival
From randomization to death from any cause, average 12 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CTX-009 plus PaclitaxelEXPERIMENTAL -
PaclitaxelACTIVE_COMPARATORPatients 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 TreatmentEXPERIMENTAL -

Interventions

NameTypeDescription
CTX-009DRUGIV infusion on day 1 and 14 of every 28 day cycle
PaclitaxelDRUGIV infusion on day 1, 8, and 15 of every 28 day cycle
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites34

INCLUSION CRITERIA 1. 18 years of age or older 2. Histologically or cytologically confirmed unresectable advanced, metastatic, or recurrent biliary tract cancers (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampullary carcinoma) 3. Patients mus...

Countries:United States
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Recent Changes (Last 90 Days)

MEDIUMSep 2, 2026NCT05506943primaryCompletionDate: changed
MEDIUMSep 2, 2026NCT05506943primaryCompletionDate: changed
MEDIUMSep 2, 2026NCT05506943primaryCompletionDate: changed
MEDIUMAug 28, 2026NCT05513742TRIAL_REMOVED: changed
MEDIUMAug 28, 2026NCT05513742TRIAL_REMOVED: changed
MEDIUMAug 28, 2026NCT05513742TRIAL_REMOVED: changed
MEDIUMAug 28, 2026NCT05513742TRIAL_REMOVED: changed

Frequently asked questions about CTX-009

What is CTX-009 used for?

CTX-009 is an investigational small molecule being studied for the treatment of biliary tract cancer and metastatic colorectal cancer. It is currently in Phase 2 clinical development for these oncology indications.

What does CTX-009 target?

CTX-009 targets DLL4 and VEGF-A, two proteins involved in tumor angiogenesis. By inhibiting these targets, the drug aims to disrupt the blood supply that tumors need to grow and spread.

Who is developing CTX-009?

CTX-009 is being developed by Compass Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol CMPX.

What phase is CTX-009 in?

CTX-009 is in Phase 2 clinical development. It has received Fast Track designation from the FDA for its investigation in biliary tract cancer.

What clinical trials is CTX-009 in?

CTX-009 is being studied in two Phase 2 trials. NCT05506943 evaluates CTX-009 in combination with paclitaxel in patients with unresectable advanced, metastatic, or recurrent biliary tract cancers. NCT05513742 evaluates CTX-009 in patients with metastatic colorectal cancer.

Is CTX-009 the same as any other drug?

CTX-009 is not known by any other names in the available information. It is a distinct investigational compound being developed by Compass Therapeutics.