Not Yet RecruitingPhase 2

A Study of Cetuximabβ Combined With Envolimab and mFOLFOX6 in Subjects With Advanced Colorectal Cancer

China42 participantsStarted 2025-05-20

Plain-language summary

A study of Cetuximabβ combined with Envolimab and mFOLFOX6 in Subjects with Advanced Colorectal Cancer

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. have agreed and signed an informed consent form (ICF) and are willing and able to comply with planned visits, study treatments, laboratory tests and other experimental procedures.
✓. At the time of signing the ICF, patients must be ≥18 years of age and have a life expectancy of ≥12 weeks in either males or females.
✓. Histologically or cytologically confirmed RAS and BRAF wild-type, MSS type colorectal adenocarcinoma.
✓. Advanced or metastatic colorectal cancer (AJCC/UICC stage IV) clearly defined by imaging, with at least one measurable lesion that meets the requirements of the criteria for evaluating the efficacy of solid tumors (RECIST version 1.1).
✓. no prior systemic therapy (including epidermal growth factor receptor inhibitors such as cetuximab or panitumumab, vascular endothelial growth factor inhibitors such as bevacizumab, immune checkpoint inhibition such as anti-PD-1 or PD-L1 antibodies, and anti-CTLA-4 antibodies) directed against advanced or metastatic colorectal cancer, but are allowed to receive a maximum of one cycle of the mFOLFOX6 regimen prior to enrollment ; Adjuvant/neoadjuvant therapy is considered a first-line systemic therapy for advanced or metastatic disease if recurrence or metastasis occurs during or within 6 months of completion of adjuvant or neoadjuvant chemotherapy.
✓. an Eastern Cooperative Oncology Group (ECOG) physical status score of 0-1.
✓. have appropriate organ function during the screening period:
✓. Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days prior to initiation of study drug administration and be willing to use a medically approved highly effective contraceptive measure (e.g., IUD, birth control pills, or condoms) during the study period and for 3 months after final study drug administration; for male subjects whose partner is a female of childbearing potential, he/she should be surgically sterilized or agree to use a medically approved highly effective contraceptive measure (e.g., IUD, birth control pills, or condoms) during the study period and for 3 months after final study drug administration. 3 months after the final study dose.

Exclusion criteria

✕. previous or concurrent other active malignancies (except for malignancies that have been curatively treated and have been free of morbidity for more than 5 years or carcinoma in situ that can be cured by adequate treatment).
✕. Current gastrointestinal diseases such as duodenal ulcer, ulcerative colitis, intestinal obstruction, or other conditions that may cause gastrointestinal bleeding or perforation as determined by the investigator.
✕. Thrombotic or embolic events such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, deep vein thrombosis within 12 months prior to enrollment in the study.
✕. Myocardial infarction, severe/unstable angina pectoris, NYHA class 2 or higher cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmia, and symptomatic congestive heart failure within 12 months prior to study entry.
✕. systemic antibiotic use for ≥ 7 days within 4 weeks prior to study entry or unexplained fever \> 38.5°C during screening/prior to first dose (fever due to oncologic causes is eligible for enrollment at the discretion of the investigator).
✕. Presence of hydrothorax, ascites, or pericardial effusion uncontrolled with effective therapy within 14 days prior to study entry.
✕. Presence of any prior treatment-induced, unabated adverse event Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0) Grade 2 or greater toxicity (excluding anemia, alopecia, and skin hyperpigmentation).
✕. Presence of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic disease (e.g., diabetes mellitus, hypertension, pulmonary fibrosis, and acute pneumonia).

What they're measuring

Progression-free survival (PFS)

Timeframe: Through out the study (up to 2 years)

Trial details

NCT IDNCT07000305

SponsorTao Zhang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-20

Contact for this trial

LI LI

+8617702740317 lili9@zaiming.com

View on ClinicalTrials.gov More Advanced Colorectal Cancer trials