A Preliminary Clinical Study on the Pharmacokinetics and Safety of CDP1 in Patients With Advanced CRC or HNSCC

This is an interventional treatment trial for Colorectal Cancer Read More

Inclusion Criteria:

• Age 18 ~ 75 (inclusive) years , male.
• Histologically or cytologically confirmed ras genotype is wild-type patients with advanced metastatic colorectal cancer, at least second-line chemotherapy (including oxaliplatin, irinotecan and fluorouracil drugs) failed, or intolerant to Irinotecan or chemotherapy-denied patients.
• ECOG physical score 0-2 points.
• Expected survival time of 3 months or more.
• According to RECIST 1.1, there is at least one assessable tumor lesion.
• No serious hematological system, liver function, renal function and coagulation dysfunction:Neutrophils ≥1.5 × 109 / L, platelets ≥75 × 109 / L, hemoglobin≥90g / L; total bilirubin≤1.5 times ULN, alanine aminotransferase (ALT)≤2.5 times ULN,aspartate transaminase (AST) ≤2.5 times ULN (liver metastasis ALT ≤ 5 times ULN, AST≤ 5 times ULN);Serum creatinine ≤1.5 times ULN;Activated partial thromboplastin time (APTT) ≤1.5 times ULN, prothrombin time (PT) ≤1.5 times ULN, international normalized ratio (INR) ≤1.5 times ULN.
• Eligible patients with fertility must agree to use reliable methods of contraception (hormonal or barrier abstinence) for at least 12 weeks during and after the last dose of medication.
• Subjects should be informed of the study prior to the test and voluntarily sign a written informed consent form.

Exclusion Criteria:

• Chemotherapy, biotherapy, radiation therapy, endocrine therapy, small molecule targeted therapies and other anti-tumor, etc. within 4 weeks prior to the start of study drug use or within 5 half-lives of the known drug (whichever is longer) Anti-cancer therapy, or other experimental drug treatment (except nitrosourea, mitomycin C and fluorouracil oral drugs),nitrosourea or mitomycin C for 6 weeks. Fluorouracil-based oral medications, such as tiotropium and capecitabine, have an interval of at least 2 weeks between the last oral dose and study drug use.
• Have previously received anti-EGFR monoclonal antibody treatment.
• EGFR antibody drug-resistant antibody (ADA) positive.
• Within 3 months prior to enrollment, major organ surgery (excluding biopsy) or significant trauma occurred.
• The adverse reactions of previous anti-tumor therapy have not been restored to CTCAE 4.03 grade ≤1 (excluding hair loss).
• Untreated or clinically symptomatic brain metastases, spinal cord compression, cancerous meningitis, or other evidence that the patient's brain, spinal metastases have not yet been controlled, the researchers judged not suitable for inclusion. clinical symptoms suspected brain or soft Membrane disease is to be ruled out by CT / MRI examination.
• Uncontrolled active infections.
• Have a history of immunodeficiency, including HIV antibody test positive.
• Treponema anti-positive.
• Chronic hepatitis B virus (HBV) infection; Hepatitis C virus (HCV) infection.
• Serious history of cardiovascular disease: including ventricular arrhythmias requiring clinical intervention; acute coronary syndromes, congestive heart failure, stroke or other cardiovascular events of grade III and higher within 6 months; New York, USA Heart Association (NYHA. Cardiac function grade ≥II or Left ventricular ejection fraction(LVEF) <50%; poorly controlled hypertension (systolic blood pressure> 150 mmHg, diastolic blood pressure> 90 mmHg).
• Interstitial lung disease.
• There are other serious history of systemic diseases, the researchers judged not suitable for clinical trials of patients.
• Alcohol or drug dependence is known.
• Persons with mental disorders or poor compliance.
• Moderate or severe infusion-related reactions, including anaphylaxis, have been reported in the past when using monoclonal antibody drugs.
• The investigators did not find it appropriate to participate in this clinical study because of any clinical or laboratory abnormalities or other causes.