New antibody shows promise in early trial for tough colorectal cancer
NCT ID NCT03017807
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a new antibody drug (similar to cetuximab) in 18 people with advanced colorectal cancer that had stopped responding to standard treatments. The main goal was to check safety and how the drug moves through the body. Participants received one of two dose levels, and researchers watched for side effects like skin reactions and lung problems.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Recombinant Anti-EGFr Antibody (similar to cetuximab)
- What this could lead to
- If successful, this could lead to a new treatment option for patients with metastatic colorectal cancer who have not responded to standard therapies.
- What could go wrong
- This is a very early phase 1 trial with only 18 participants, so safety and dosing are still being figured out. The drug may not work or could cause serious side effects like severe skin reactions or lung problems.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
18 people
The number who actually took part.
- Started
-
Dec 2016
- Finished
-
Jan 2018
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Ages eligible for study between 18 Years and 75 Years. 2. Confirmed histological diagnosis of colorectal cancer. 3. Subjects with advanced/metastatic Colorectal Cancer(CRC) who have failed to the irinotecan- ,oxaliplatin- and fluoropyrimidine-based regimens or been intolerant to irinotecan or rejected the chemotherapy. 4. Eastern Cooperative Oncology Group (ECOG) of 0 or 1. 5. Subjects must have a life expectancy of at least 12 weeks. 6. Patients with at least one evaluable lesion (evaluable disease) by the RECIST criteria. 7. Adequate renal function (creatinine ≤ 1.5 x UNL), liver function (total bilirubin ≤ 1.5 x UNL, alanine aminotransferase(ALT)\< 2.5 x UNL, aspartate aminotransferase(AST) \< 2.5 x UNL or ≤ 5 x UNL if hepatic metastasis) and leucocytes ≥ 3×10\^9, absolute neutrophil count ≥ 1.5×10\^9/L, platelets \> 80×10\^9/L, haemoglobin ≥ 9 g/dl. Electrolyte: in the normal range, or abnormal but no clinical significance (judged by the researchers), allow to give supplements to correct the electrolyte. 8. Both women of child-bearing potential and sexually active men must agree to use adequate contraception prior to study entry and for the duration of study participation and for 90 days after the conclusion of study therapy. 9. Patients who have capable to understand the procedure and methods of the study,are willing to strictly follow the protocol and sign the the informed consent. Exclusion Criteria: 1. Previous therapy with anti-EGFR drugs. 2. Patients who are receiving other accompanying antineoplastic therapy (including antitumor treatment with traditional Chinese medicine), long-term systemic immune therapy, or hormone therapy except for physiological replacement therapy (for example, people with thyroid hypofunction receive the thyroid hormone). 3. Radiotherapy or surgery (except always diagnostic biopsy). 4. Patients with known cerebral metastasis or leptomeningeal metastasis. 5. Any other malignant tumour in the last five years, except for suitably treated in situ cervical carcinoma or basal cell carcinoma. 6. Clinically significant cardiovascular disease, such as heart failure (NYHA Ⅲ-Ⅳ), uncontrolled coronary heart disease, cardiomyopathy, cardiac arrhythmias, hypertension (\> 140/90 mmHg), myocardial infarction in the last half year, echocardiogram showed ejection fraction \< 50%. 7. Patients with any symptom of acute or subacute bowel obstruction and/or inflammatory bowel disease. 8. Patients with known active and severe infections(\> grade 2, National Cancer Institute Common Toxicity Criteria(NCI-CTC) adverse effect(AE) V. 4.03), including active tuberculosis(TB). 9. HIV infection or active hepatitis B or hepatitis C. 10. Uncontrolled diabetes (\> grade 2, NCI-CTC AE V. 4.03), severe lung disease (acute lung disease, pulmonary fibrosis that affect the lung function, and interstitial lung disease), liver failure. 11. Patients with blood coagulation dysfunction as following situation: prothrombin time (PT) ≥ 1.5 x UNL, thrombin time (TT) ≥ 1.5 x UNL, the part activated clotting time (APTT) ≥ 1.5 x UNL. 12. Patients who have blood transfusion, or use the g-csf cytokines etc in the last 10 days. 13. Known hypersensitivity to any component of pretreated product. 14. Pregnancy or breastfeeding. 15. Patients with known drug and/or alcohol abuse. 16. Patients with a clear history of neurological or psychiatric disorders, including epilepsy or dementia. 17. Patient participation in another clinical trial or receive other research drugs during the previous 4 weeks. 18. Patients with a medical or mental abnormalities unable to give informed consent. 19. Lack of legal behavior ability or limited legal behavior ability. 20. Other factors that may affect the efficacy or safety evaluation of this study assessed by researchers.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Sichuan Kelun Pharmaceutical Co., Ltd.
Chengdu, China
More trials for these conditions
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