Trial Title:
A Study of CTX-009 in Adult Patients With Metastatic Colorectal Cancer
NCT ID:
NCT05513742
Condition:
Metastatic Colorectal Cancer
Colon Cancer
Rectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention 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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CTX-009
Description:
IV infusion administered on day 1 and 15 of every 28-day cycle
Arm group label:
CTX-009 Treatment
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 enrolled.
Criteria for eligibility:
Criteria:
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 planned C1D1.
4. 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).
1. Patients whose tumor is not right sided and RAS wild type must also have
received an anti-epidermal growth factor receptor (EGFR) therapy.
2. 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.
3. If patient received peri-operative treatment (neoadjuvant and/or adjuvant),
please consult the Sponsor Medical Monitor for review of prior treatment lines.
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
4. Urine protein ≤ 1+ by spot urinalysis (or, if > 1+ then 24 hr urine protein
<1.0 g/24 hr)
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 planned C1D1,
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 may be
exclusionary, as determined by the Sponsor Medical Monitor:
1. 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)
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, direct thrombin inhibitors, etc.) within 2
weeks prior to C1D1, or are 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. History of cerebrovascular incident (ischemic or hemorrhagic stroke), transient
ischemic attack or subarachnoid hemorrhage within 6 months prior to screening
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Genesis Cancer and Blood Institute
Address:
City:
Hot Springs
Zip:
71913
Country:
United States
Facility:
Name:
Florida Cancer Specialists & Research Institute - South
Address:
City:
Fort Myers
Zip:
33916
Country:
United States
Facility:
Name:
Florida Cancer Specialists & Research Institute - North
Address:
City:
Saint Petersburg
Zip:
33705
Country:
United States
Facility:
Name:
Rutgers Cancer Institute of New Jersey
Address:
City:
New Brunswick
Zip:
08903
Country:
United States
Facility:
Name:
Zangmeister Cancer Center
Address:
City:
Columbus
Zip:
43219
Country:
United States
Facility:
Name:
SCRI Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Facility:
Name:
Mary Crowley Cancer Research
Address:
City:
Dallas
Zip:
75230
Country:
United States
Start date:
December 8, 2022
Completion date:
December 2024
Lead sponsor:
Agency:
Compass Therapeutics
Agency class:
Industry
Source:
Compass Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05513742