A Study of CTX-009 in Adult Patients With Metastatic Colorectal Cancer (NCT05513742) | Clinical Trial Compass
CompletedPhase 2
A Study of CTX-009 in Adult Patients With Metastatic Colorectal Cancer
United States49 participantsStarted 2022-12-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. 18 years of age or older
ā. Histologically or cytologically confirmed metastatic or recurrent colorectal cancers
ā. The primary tumor must have been resected \> 3 months prior to planned C1D1.
ā. 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).
ā. Patients whose tumor is not right sided and RAS wild type must also have received an anti-epidermal growth factor receptor (EGFR) therapy.
ā. 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.
ā. If patient received peri-operative treatment (neoadjuvant and/or adjuvant), please consult the Sponsor Medical Monitor for review of prior treatment lines.
ā. At least one lesion measurable as defined by RECIST v1.1
Exclusion criteria
ā. From the time point of signed informed consent,
ā. Less than 4 weeks have elapsed since patients had a surgery or major procedure
What they're measuring
1
Overall Response Rate
Timeframe: From Cycle 1 Day 1 (C1D1) to treatment discontinuation for any reason, average of 6 months
. Less than 2 weeks have elapsed from the last treatment date since patients had any radiation therapy
ā. Prior to planned C1D1,
ā. Less than 4 weeks have elapsed since patients had chemotherapy or targeted therapy for colorectal cancer
ā. Less than 4 weeks have elapsed since patients had anticancer immunotherapy or investigational drug treatment
ā. A history of the following cardiovascular diseases in past 5 years may be exclusionary, as determined by the Sponsor Medical Monitor:
ā. 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)