Colorectal Cancer, Non-small cell lung cancer, Head and Neck Cancer, Esophageal Cancer, etc.
Conditions
Interventions
Case series:GR1401 monoclonal antibody
Sponsors
307th Hospital of Chinese People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years; 2. Advanced solid tumor (Colorectal Cancer, Non-small cell lung cancer, Head and Neck Cancer, Esophageal Cancer, etc.) patients who had evaluable tumor lesions per RECIST 1.1 guidelines, failed to standard treatment or intolerance or resistance to the existing treatment; 3. No serious hematologic function abnormalities (Absolute neutrophil count (ANC) =1.5*10^9/L, Platelet count=100*10^9/L, Hemoglobin=90g/L); 4. No serious organic pathological changes in the liver, heart and kidney(Left ventricular ejection fraction (LVEF) =50%; Total bilirubin=1.5×ULN; Alanine aminotransferase (ALT) =2.5×ULN (if liver metastases=5×ULN); Aspartate aminotransferase (AST) =2.5×ULN (if liver metastases=5×ULN); Serum Creatinine = 1.5×ULN or CCr >50mL/min); 5. At least 4 weeks after the last anti-tumor treatment (Surgery, Chemotherapy, Radiation Th erapy, Biotherapy or Endocrine Therapy) before study entry; 6. Life expectancy of = 3 months; 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 8. Wild-type RAS for metastatic colorectal cancer as determined by approved tests; 9. Consent to participate in the research study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Unresolved toxicities (>CTCAE grade 1) from previous anti-cancer treatment or not completely recovered from the previous surgery; 2. Prior received treatment with drugs targeting EGFR; 3. Subjects with other malignant tumors previously or concurrently (with the exception of the stages IB or lower level in cured cervical cancer, non invasive basal cell or squamous cell skin cancer, breast cancer with complete remission (CR) (>10 years), malignant melanoma with complete remission (CR) (>10 years) and other malignant tumors with complete remission (CR) (>5 years)); 4. Female patients with pregnancy or lactation; 5. Women/men who have fertility refusal to adopt contraception during the trial period; 6. Subjects with serious disease or complications, such as gastrointestinal bleeding, intestinal obstruction, intestinal paralysis, interstitial pneumonia, pulmonary fibrosis, renal failure, glaucoma, uncontrolled diabetes (CTCAE= 4.03: fasting blood glucose level = 2), and with active infection; 7. Had history of acute myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack in the first 6 months of the screening, grade 2 or above congestive heart failure devised by the New York Heart Association (NYHA); 8. Subjects with symptomatic brain metastases or mental disorders; 9. Subjects with abnormal levels of serum calcium, magnesium, potassium and have clinical significance; 10. Subjects with history of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation; 11. Subjects with active hepatitis B (HBsAg and/or HBcAb positive, and HBV DNA titer in peripheral blood was greater than 1 x 103 IU/ml), and/or hepatitis C; 12. Subjects who have alcohol addiction and/or drug abuse; 13. Subjects with bleeding or coagulation dysfunction in the past 3 months (PT>1.5×ULN; APTT>1.5×ULN; TT>1.5×ULN); 14. Subjects with allergic constitution or allergic to known components of the drug; 15. Less than one month from the last clinical trial; 16. Other subjects judged by the investigator to be ineligible for enrollment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose;Dose limiting toxicity;Safety assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| T1/2, Cmax, Tmax, AUC0-t, AUC0-8, AUCss, Cav, CL, etc.;Immunogenicity;Preliminary antitumor effect; | — |
Countries
China
Contacts
Public ContactJianming Xu
307th Hospital of Chinese People's Liberation Army
Outcome results
None listed