MC# 22-38 - A Phase II Study of CTX-009 in Adult Patients with Metastatic Colorectal Cancer who have received Two or Three Prior Systemic Chemotherapy Regimens

  • Agent(s): CTX-009
  • Disease Type(s): Colorectal
  • Phase(s): II
  • Drug Classification(s): Immunotherapy, Bispecific Antibodies
  • Molecular Target(s): DLL4, VEGF-A

Mechanism of Action

CTX-009 simultaneously targets, binds to and blocks DLL4 and VEGF-A. This prevents the activation of DLL-4/Notch- and VEGF-A/VEGF receptor (VEGFR)-mediated signaling pathways, which play key roles in angiogenesis and tumor vascularization. This prevents angiogenesis and may halt tumor cell proliferation.


In this study, the sponsor and investigators want to learn:

  • If CTX-009 prevents or delays tumor growth or shrinks existing tumors
  • The effects of CTX-009 (good and bad) 
Inclusion Criteria
  1. 18 years of age or older
  2. Histologically or cytologically confirmed metastatic or recurrent colorectal cancers
  3. The primary tumor must have been resected > 3 months prior to starting therapy with CTX-009
  4. Patients who experienced progressive disease or relapse after receiving two or three prior lines of systemic therapy in the metastatic setting. Prior lines of systemic treatment must have included at least one fluoropyrimidine, oxaliplatin, irinotecan, and bevacizumab containing chemotherapy regimen (in any combination). Patients whose tumor is not right sided and k-ras wild type must also have received an anti-epidermal growth factor receptor (EGFR) therapy
  5. At least one lesion measurable as defined by RECIST v1.1
  6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  7. Predicted life expectancy of at least 12 weeks
  8. Adequate hepatic and renal function within 14 days of C1D1 as described below:
    1. Total bilirubin ≤ 1.5 X upper limit of normal (ULN)
    2. Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) ≤ 3.0 X ULN (≤ 5x ULN in case of hepatic metastasis)
    3. Estimated creatinine clearance ≥ 30 mL/min based on Cockcroft-Gault estimated creatinine clearance
  9. 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
  10. 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.
  11. Signed and dated Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form (ICF) before any protocol-directed screening procedures are performed
Exclusion Criteria
  1. From the time point of signed informed consent,
    1. Less than 4 weeks have elapsed since patients had a surgery or major procedure
    2. Less than 2 weeks have elapsed from the last treatment date since patients had any radiation therapy
  2. Prior to the initial treatment of investigational product,
    1. Less than 4 weeks have elapsed since patients had chemotherapy or targeted therapy for colorectal cancer
    2. Less than 4 weeks have elapsed since patients had anticancer immunotherapy or investigational drug treatment
  3. A history of the following cardiovascular diseases in past 5 years:
    1. Congestive heart failure that corresponds to Class II or a higher class (or less than 50% of left ventricular ejection fraction (LVEF)) under New York Heart Association (NYHA) classification
    2. 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)
    3. Patients with a history of hypertensive crisis or pre-existing hypertensive encephalopathy
    4. Pulmonary hypertension
    5. Myocardial infarction
    6. Uncontrolled arrhythmia
    7. Unstable angina
    8. 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
  4. 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)
  5. A history of the following hemorrhage-related or gastroenterological disease:
    1. Active hemorrhage, hemorrhagic diathesis, coagulopathy or tumor invasion into great arteries
    2. 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
  6. Patients who received antiplatelet drugs (aspirin, clopidogrel, etc.) or anticoagulant drugs (warfarin, heparin, etc.) within 2 weeks prior to screening, or is expected to need those drugs during the clinical study
  7. Patients requiring continuous treatment with systemic non-steroidal anti-inflammatory drugs (NSAIDs) or systemic corticosteroids (the following cases are permitted):
    1. NSAIDs: Up to 3 consecutive days' use is permitted
    2. 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
  8. Severe infection requiring systemic antibiotics, antivirus drugs, etc., or other uncontrolled acute active infectious diseases
  9. 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
  10. 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:
    1. Pre-existing hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 28 days prior to screening
    2. Major, unhealed injury, active ulcer or untreated fracture
    3. Pre-existing history of a cerebrovascular incident (ischemic or hemorrhagic stroke), transient ischemic attack or subarachnoid hemorrhage within 6 months prior to screening 1
    4. Moderate to severe ascites and/or pleural effusion
  11. Clinically significant abnormal electrocardiography (ECG) findings or history determined as clinically significant by the Investigator
  12. QT interval (Fridericia's formula) (QTcF) interval > 450 msec at the time of screening


  • Dallas, TX - Mary Crowley Cancer Research - Medical City
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Re: MC# 22-38