Metastatic Colorectal CancerPhase 2COMPANION-003NCT05513742
A Study of CTX-009 in Adult Patients With Metastatic Colorectal Cancer
A Phase 2 study testing CTX-009 in people with Metastatic Colorectal Cancer and Colon Cancer, run by Compass Therapeutics at 7 sites in United States.
Trial summary
This study is designed as an open-label, adaptive Simon Two-Stage study to evaluate the efficacy of CTX-009 in patients with metastatic colorectal cancer. A Simon Two-Stage adaptive design will enroll approximately 37 patients into Stage 1, and if criteria are met to move to Stage 2, an additional 47 patients will be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer, Colon Cancer, Rectal Cancer
- What is being tested?
- CTX-009
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 7 sitesUnited States
- Study dates
- 8 Dec 2022to 15 May 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Histologically or cytologically confirmed metastatic or recurrent colorectal cancers
- The primary tumor must have been resected > 3 months prior to planned C1D1.
- Patients who experienced progressive disease or relapse after receiving two or three prior lines of systemic therapy in the locally advanced or metastatic setting. Prior lines of systemic treatment must have included at least one fluoropyrimidine, oxaliplatin, irinotecan, and bevacizumab containing chemotherapy regimen (in any combination and may have been administered in the neoadjuvant setting).
- Patients whose tumor is not right sided and RAS wild type must also have received an anti-epidermal growth factor receptor (EGFR) therapy.
- Patients with tumors harboring mutations or other alterations for which there are available targeted therapies (e.g. BRAF V600E, HER2-positive, MSI-H/dMMR, etc.) must have also received the relevant approved targeted therapies.
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- If patient received peri-operative treatment (neoadjuvant and/or adjuvant), please consult the Sponsor Medical Monitor for review of prior treatment lines.
- At least one lesion measurable as defined by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Predicted life expectancy of at least 12 weeks
- Adequate hepatic and renal function within 14 days of C1D1 as described below:
- Total bilirubin ≤ 1.5 X upper limit of normal (ULN)
- Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) ≤ 3.0 X ULN (≤ 5x ULN in case of hepatic metastasis)
- Estimated creatinine clearance ≥ 30 mL/min based on Cockcroft-Gault estimated creatinine clearance
- Urine protein ≤ 1+ by spot urinalysis (or, if > 1+ then 24 hr urine protein <1.0 g/24 hr)
- Female patients who are women of childbearing potential (WCBP) must have a negative pregnancy test (serum-human chorionic gonadotropin [hCG] or urine-hCG) at Screening within 14 days of C1D1
- Female patients must be surgically sterile (or have a monogamous partner who is surgically sterile) or be at least 2 years postmenopausal or commit to use 2 acceptable forms of birth control (defined as the use of an intrauterine device (IUD), a barrier method with spermicide, condoms, any form of hormonal contraceptives, or abstinence) for the duration of the study and for 4 months following the last dose of study treatment. Male patients must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study and for 4 months following the last dose of study treatment
- Signed and dated Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form (ICF) before any protocol-directed screening procedures are performed
Who cannot join
- From the time point of signed informed consent,
- Less than 4 weeks have elapsed since patients had a surgery or major procedure
- Less than 2 weeks have elapsed from the last treatment date since patients had any radiation therapy
- Prior to planned C1D1,
- Less than 4 weeks have elapsed since patients had chemotherapy or targeted therapy for colorectal cancer
- Less than 4 weeks have elapsed since patients had anticancer immunotherapy or investigational drug treatment
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- A history of the following cardiovascular diseases in past 5 years may be exclusionary, as determined by the Sponsor Medical Monitor:
- Congestive heart failure that corresponds to Class II or a higher class under New York Heart Association (NYHA) classification or less than 50% of left ventricular ejection fraction (LVEF)
- Uncontrolled hypertension (systolic blood pressure [SBP]/diastolic blood pressure [DBP] > 140/90 mmHg) (e.g., patient with SBP/DBP > 140/90 mmHg despite the best care including anti-hypertensive medications)
- Patients with a history of hypertensive crisis or pre-existing hypertensive encephalopathy
- Pulmonary hypertension
- Myocardial infarction
- Uncontrolled arrhythmia
- Unstable angina
- Patients with any significant vascular diseases (e.g., aortic aneurysm requiring surgery or recent peripheral artery thrombosis) within 6 months prior to the initial treatment of the investigational product
- Symptomatic or uncontrolled central nervous system (CNS) metastasis (However, patients with asymptomatic CNS metastasis can participate provided that systemic corticosteroid treatment was discontinued at least 4 weeks prior to screening and that the patient is radiologically and neurologically stable or improving)
- A history of the following hemorrhage-related or gastroenterological disease:
- Active hemorrhage, hemorrhagic diathesis, coagulopathy or tumor invasion into great arteries
- History of clinically significant and active (within 6 months) gastroenterological disease, such as peptic ulcer, gastrointestinal (GI) bleeding, GI or non-GI fistula, perforation, abdominal abscess, clinical symptoms and signs of GI obstruction, need for parenteral hydration or nutrition, or inflammatory bowel disease.
- Patients who received antiplatelet drugs (aspirin, clopidogrel, etc.) or anticoagulant drugs (warfarin, heparin, direct thrombin inhibitors, etc.) within 2 weeks prior to C1D1, or are expected to need those drugs during the clinical study.
- Patients requiring continuous treatment with systemic non-steroidal anti-inflammatory drugs (NSAIDs) or systemic corticosteroids (the following cases are permitted):
- NSAIDs: Up to 3 consecutive days' use is permitted
- Corticosteroids: Topical use of corticosteroid, such as topical intra-articular injection, intranasal administration, eye drops, inhaler, etc., or temporary systemic corticosteroid use for treatment and prevention of patient's contrast media allergy, or adverse event, is permitted
- Severe infection requiring systemic antibiotics, antivirus drugs, etc., or other uncontrolled acute active infectious diseases
- Patients with evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Inactive hepatitis B carriers who tested HBsAg positive may enroll provided that the patient's liver function values are normal. Also, patients with chronic HBV infection which has been controlled by the site's treatment guideline may enroll. HCV patients showing sustained viral response or patients with immunity to HBV infection may enroll
- Patients with other severe diseases or uncontrolled illnesses that warrant the exclusion from the study (permitted only if medically controlled) including but not limited to:
- Pre-existing hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 28 days prior to screening
- Major, unhealed injury, active ulcer or untreated fracture
- History of cerebrovascular incident (ischemic or hemorrhagic stroke), transient ischemic attack or subarachnoid hemorrhage within 6 months prior to screening
- Moderate to severe ascites and/or pleural effusion
- Clinically significant abnormal electrocardiography (ECG) findings or history determined as clinically significant by the Investigator
- QT interval (Fridericia's formula) (QTcF) interval > 450 msec at the time of screening
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Zangmeister Cancer Center
Columbus, Ohio, 43219
Mary Crowley Cancer Research
Dallas, Texas, 75230
Florida Cancer Specialists & Research Institute - South
Fort Myers, Florida, 33916
Genesis Cancer and Blood Institute
Hot Springs, Arkansas, 71913
SCRI Oncology Partners
Nashville, Tennessee, 37203
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Florida Cancer Specialists & Research Institute - North
St. Petersburg, Florida, 33705
About this study
Official title: A Phase 2 Study of CTX-009 in Adult Patients With Metastatic Colorectal Cancer Who Have Received Two or Three Prior Systemic Chemotherapy Regimens
This study is designed as an open-label, adaptive Simon Two-Stage study to evaluate the efficacy of CTX-009 in patients with metastatic colorectal cancer.
A Simon Two-Stage adaptive design will enroll approximately 37 patients into Stage 1, and if criteria are met to move to Stage 2, an additional 47 patients will be enrolled.
- Conditions
- Metastatic Colorectal Cancer, Colon Cancer, Rectal Cancer
- Being tested
- CTX-009
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTX-009Drug
IV infusion administered on day 1 and 15 of every 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| CTX-009 Treatment | Experimental | Not described Receives: Drug: CTX-009 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
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.
Measured: From first dose of CTX-009 until treatment discontinuation (an average of 16 weeks)
Secondary outcomes (5)
Disease Control Rate
Percentage of all treated patients whose best overall response was complete response (CR), partial response (PR), or stable disease (SD) for a minimum of 6 weeks. 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; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Measured: From first dose of CTX-009 until treatment discontinuation (an average of 16 weeks)
Duration of Response
Time from the CT or MRI that first confirmed complete (CR) or partial response PR) to the CT or MRI that first confirmed progression of disease progression (PD). 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; PD = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: From first date of complete or partial response to first date of disease progression or death (up to 15.4 weeks)
Progression-free Survival
Time from first dose of CTX-009 to progression of disease or death. Progression of diseases is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: From first dose of CTX-009 to disease progression or death (up to 5.8 months)
Overall Survival
Time from first dose of CTX-009 to death
Measured: From first dose of CTX-009 to death (up to 17.8 months)
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
TEAE is defined by occurrence of an adverse event that started or worsened in severity on or after the first dose of CTX-009 through 30 days after the last dose of CTX-009. Change in clinical abnormalities is defined as an increase in abnormality grade in a laboratory result, vital sign, or ECG parameter from predose result to worst postdose result (graded according to the Common Terminology Criteria for Adverse Events v5.0 for all analytes except for brain natriuretic peptide and troponin subtypes, which are interpreted in reference to the laboratory reference range for each), a post-baseline potentially clinically significant vital sign abnormality, or a post-baseline potentially clinically significant ECG abnormality.
Measured: From the first CTX-009 dose to 30 days after the last CTX-009 dose (average 20 weeks) for TEAEs, from the first CTX-009 dose to 60 days after the last CTX-009 dose (average 25 weeks) for lab tests, vital signs, and ECGs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start8 Dec 2022
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Approximately 37 patients will be enrolled into Stage 1, and if criteria are met to move to Stage 2, an additional 47 patients will be enrolled, for a total of approximately 84 patients.
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Compass Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Minori Rosales, MD, PhD, Study director, Compass Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513742
- Sponsor's protocol ID
- CTX-009-003
- Acronym
- COMPANION-003
- Status last verified
- Jun 2025
- First submitted
- 22 Aug 2022
- Last updated
- 25 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of CTX-009 in Adult Patients With Metastatic Colorectal Cancer Who Have Received Two or Three Prior Systemic Chemotherapy Regimens
- ClinicalTrials.gov ID
- NCT05513742
- Acronym / sponsor ID
- COMPANION-003 / CTX-009-003
- Conditions
- Metastatic Colorectal Cancer, Colon Cancer, Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Compass TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 24 Aug 2022 (actual)
- Results
- Posted 28 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed as an open-label, adaptive Simon Two-Stage study to evaluate the efficacy of CTX-009 in patients with metastatic colorectal cancer.
A Simon Two-Stage adaptive design will enroll approximately 37 patients into Stage 1, and if criteria are met to move to Stage 2, an additional 47 patients will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Approximately 37 patients will be enrolled into Stage 1, and if criteria are met to move to Stage 2, an additional 47 patients will be enrolled, for a total of approximately 84 patients.
| Arm | Type | Receives |
|---|---|---|
| CTX-009 Treatment | Experimental | Drug: CTX-009 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 18 years of age or older
- Histologically or cytologically confirmed metastatic or recurrent colorectal cancers
- The primary tumor must have been resected > 3 months prior to planned C1D1.
- Patients who experienced progressive disease or relapse after receiving two or three prior lines of systemic therapy in the locally advanced or metastatic setting. Prior lines of systemic treatment must have included at least one fluoropyrimidine, oxaliplatin, irinotecan, and bevacizumab containing chemotherapy regimen (in any combination and may have been administered in the neoadjuvant setting).
- At least one lesion measurable as defined by RECIST v1.1
Key exclusion criteria (32 listed)
- From the time point of signed informed consent,
- Prior to planned C1D1,
- A history of the following cardiovascular diseases in past 5 years may be exclusionary, as determined by the Sponsor Medical Monitor:
- Symptomatic or uncontrolled central nervous system (CNS) metastasis (However, patients with asymptomatic CNS metastasis can participate provided that systemic corticosteroid treatment was discontinued at least 4 weeks prior to screening and that the patient is radiologically and neurologically stable or improving)
- A history of the following hemorrhage-related or gastroenterological disease:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTX-009IV infusion administered on day 1 and 15 of every 28-day cycle | Drug | CTX-009 Treatment |
Primary outcome
Overall Response Rate
Time frame: 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.
5 secondary outcomes
Disease Control Rate
Time frame: From first dose of CTX-009 until treatment discontinuation (an average of 16 weeks)
Duration of Response
Time frame: From first date of complete or partial response to first date of disease progression or death (up to 15.4 weeks)
Progression-free Survival
Time frame: From first dose of CTX-009 to disease progression or death (up to 5.8 months)
Overall Survival
Time frame: From first dose of CTX-009 to death (up to 17.8 months)
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Time frame: From the first CTX-009 dose to 30 days after the last CTX-009 dose (average 20 weeks) for TEAEs, from the first CTX-009 dose to 60 days after the last CTX-009 dose (average 25 weeks) for lab tests, vital signs, and ECGs.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minori Rosales, MD, PhD study director
Compass Therapeutics
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CTX-009 in people with Metastatic Colorectal Cancer and Colon Cancer, run by Compass Therapeutics at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: From first dose of CTX-009 until treatment discontinuation (an average of 16 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.