Colorectal Cancer
Conditions
Interventions
Group A in Part A trial:GR007 90 mg is injected for 3 consecutive days starting from Day 2 before each round of FOLFIRI chemotherapy
Group B in Part A trial:GR007 90 mg is injected for 5 consecutive days starting from Day 4 before each round of FOLFIRI chemotherapy
Dose cohort 1 in Part B trial:GR007 dosage selected based on Part A trial is injected before each round of 1.25 times dose FOLFIRI (except for calcium folinate)
Dose cohort 2 in Part B trial:GR007 dosage selected based on Part A trial is injected before each round of 1.5 times dose FOLFIRI (except for calcium folinate)
expension group in Part B trial:dose cohort completes in the dose escalation trial, 30 more subjects will be added to enter the expansion trial
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)Aged 18-75 (including) years, male or female; 2)Patients with histologically or cytologically confirmed advanced metastatic colorectal cancer that cannot be surgically resected, who have failed oxaliplatin-containing first-line chemotherapy regimen; 3)Patients with at least measurable tumor lesion according to RECIST1.1; 4)ECOG performance status score of 0-2 points; 5)Expected survival > 6 months; 6)Toxic and side reactions caused by previous treatment should recover to grade =1 (NCI CTCAE 5.0, except for hair loss); 7)Adequate bone marrow reserve function, liver function, renal function, coagulation function:ANC =1.5×10^9/L, PLT =75×10^9/L, Hb=100 g/L; TBIL =1.5×ULN, ALT =3×ULN, AST =3×ULN (for patients with liver metastasis, ALT =5×ULN, AST =5×ULN); Cr =1.5×ULN, or creatinine clearance = 50 mL/min (calculated by Cockroft-Gault formula);INR=1.5×ULN, APTT =1.5×ULN; 8)Patients with childbearing potential (men and women) must agree to use reliable contraceptive methods (hormone or barrier method or abstinence) during the trial period and within at least 12 weeks after the last administration; female patients of childbearing potential must have a negative blood or urine pregnancy test result during the screening period; 9)Subjects must give informed consent to the study before the trial, and voluntarily sign the written informed consent form.
Exclusion criteria
Exclusion criteria: 1)Patients with a history of other primary malignant tumor or a history of tumor recurrence within 3 years (except for locally resected skin cancer and cervical carcinoma in situ, but melanoma needs to be excluded); 2)Patients who have received systemic antitumor treatment within 4 weeks before using the study drug for the first time, including but not limited to chemotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, Chinese medicine treatment, etc. (nitrosourea or mitomycin C within 6 weeks before using the study drug for the first time, and oral fluorouracil and small molecule targeted drugs within 2 weeks before using the study drug for the first time); 3)Patients who have received radiotherapy or interventional treatment with other clinical trial drugs within 4 weeks before using the study drug for the first time; 4)Patients who have been previously treated with irinotecan; 5)Patients who have received IL-1/IL-1Ra/IL-1R treatment within 4 weeks before initiating the study drug; 6)Patients with a history of immunodeficiency disease, including patients with positive HIV antibody test (enzyme-linked immunosorbent assay or Western blotting) results; 7)Patients with a history of serious cardiovascular diseases: Ventricular arrhythmia requiring clinical intervention;Acute coronary syndrome, congestive heart failure, stroke or other grade III or above cardiovascular events within 6 months;New York Heart Association (NYHA) cardiac function classification = class II or left ventricular ejection fraction (LVEF) 1000 copies/mL), or anti-HCV antibody-positive patients; 11)Pregnant or breastfeeding women; 12)Patients known to be allergic to the active ingredient of the test drug; 13)The investigator believes that the subject has any clinical or laboratory test abnormality or is not suitable for participating in the clinical study due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total incidence of grade =3 AE and SAE (except for hair loss);Incidence of grade =3 CIN and CID;Total incidence of CIN and CID; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;PFS;Total incidence of toxic and side effects of chemotherapy;Incidence and frequency of FN;Number of chemotherapy delays or hospitalization due to toxic and side effects of chemotherapy and number of days;Number of applications of salvage drugs for the treatment of toxic and side effects of chemotherapy;Immunogenicity; | — |
Countries
China
Contacts
Public ContactJin Li
Shanghai East Hospital
Outcome results
None listed