Efficacy and Safety Study of Combination of CPGJ602 and Chemotherapy, in First Line, With Wild KRAS/NRAS/BRAF in Metastatic Colorectal Cancer

NCT04466254 | Unknown Phase 2

• 1 other identifier: SSGJ-602-mCRC-II-01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the efficacy and safety of the combination of CPGJ602 and chemotherapy in subjects with KRAS/NRAS/BRAF wild-type, metastatic colorectal cancer.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Best of Response (BOR)

  Defined as the percentage of patients whose overall response is CR or PR from day 1 to 16th week of study and maintain at least until efficacy confirmation assessment (4 weeks ± 2 days), per RECIST v1.1 for target lesions assessed by BIRC.

  for 16 weeks

Secondary Outcomes (6)

• Progression Free Survival (PFS)

  for 16 weeks

• BOR Assessed by investigator

  for 16 weeks

• Disease Control Rate (DCR)

  for 16 weeks

• unConfirmed BOR at the end of 16th week by BICR and Investigator.

  for 16 weeks

• Time to Tumor Response (TTR)

  for 16 weeks

Study Arms (3)

Arm A

EXPERIMENTAL

CPGJ602 325mg/m2 IV Q2W； mFOLFOX6 therapy starts on day 1 and ends on day 2, then repeats every 2 weeks.

Drug: CPGJ602

Arm B

EXPERIMENTAL

CPGJ602 400 mg/m2 IV in the first infusion， then 250mg/m2 followed per every week； mFOLFOX6 therapy starts on day 1 and ends on day 2, then repeats every 2 weeks

Drug: CPGJ602

Arm C

ACTIVE COMPARATOR

cetuximab 400 mg/m2 IV in the first infusion， then 250mg/m2 followed per every week； mFOLFOX6 therapy starts on day 1 and ends on day 2, then repeats every 2 weeks

Drug: cetuximab

Interventions

CPGJ602 DRUG

Q2W/QW iv

Arm A; Arm B

cetuximab DRUG

QW iv

Arm C

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• informed consent to study procedures, male or female， 18-80 years old.
• Histologically or cytologically proven diagnosis of unresectable metastatic colorectal cancer
• Patients were confirmed by central lab with KRAS, NRAS and BRAF wild type. All patients must undergo a fresh tumor biopsy during the screening process, or provide archived tumor samples
• EOCG: 0\~1 within 7 days prior to first treatment
• Life expectancy of at least 3 months
• Patients must have adequate hematology, liver and kidney function, (had been received no blood transfusion, albumin, recombinant human thrombopoietin or colony stimulating factor therapy, renal replacement therapy, etc. within 14 days prior to the first study drug therapy, and the laboratory tests met the following requirements):
• Hepatic: white blood count (WBC)≥ 3.0 × 109, absolute neutrophil count (ANC)≥ 1.5 x 109/L, platelet count (PLT)≥ 100 x 109/L, haemoglobin (Hb) ≥ 90 g/dL.
• Liver: total bilirubin (T-Bil)≤ 1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤5 × ULN if with liver involvement) Kidney: Serum albumin ≥28 g/L, urea nitrogen 1.5 ×the ULN (If the center cannot detect BUN, it could be substituted by detecting urea), serum creatinine ≤1.5 × the ULN or creatinine clearance≥50mL/min
• According to RECIST1.1, the subject should have an assessable lesion
• Able to understand and willing to sign the Informed Consent Form (ICF)
• Patients with good compliance assessed by investigator

You may not qualify if:

• Those who have received any previous anti-tumor therapy such as salvage chemotherapy, targeted therapy, biological immunotherapy, etc. (The treatment of adjuvant, neoadjuvant and radiotherapy sensitized chemotherapy discontinued 6 months or more \[platinum containing chemotherapy should be treated for at least 12 months\]. Patients with disease progression can be enrolled and chemotherapy-related toxicity should be restored to grade 1 or below \[except for hair loss\])
• Patients who have had surgery within 28 days prior to first treatment with the study drug. While, those who had primary excision or palliative ostomy with good recovery within 14 days before receiving the first study drug
• Those who received radiotherapy within 28 days prior to first dose of study drug, while those who received palliative radiotherapy and recovered well within 14 days prior to receiving the study drug
• Patients with other serious uncontrolled disease (e.g. interstitial pneumonia, epilepsy, hepatic failure, etc)
• Patients had other active malignant tumor, except for the followings:
• The under-treated non-melanoma skin cancer;Cured cervical cancer or basal cell carcinoma of the skin, mammary gland ductal carcinoma in situ, and phase 1, grade 1 endometrial carcinoma
• Patients infected as followings; Hepatitis B: HBV DNA titer\> 2000 IU/ml; Hepatitis C: HCV RNA titer\>ULN; HIV infection; Serious bacterial infection; Active mycobacterium tuberculosis infection; Serious other active microbial and parasitic infections.
• History of psychiatric, psychological illness (except for those patients whose mild mental illness have been cured for more than 3 years and have no signs of recurrence assessed by the researchers), or had history of alcohol or drug abuse
• Known or suspected to have brain metastases and/or cerebrospinal meningitis
• Patients with acute or subacute intestinal obstruction, or with a history of inflammatory bowel disease， or who had gastrointestinal perforation and unhealed
• Patients with serious cardiovascular and cerebrovascular diseases，these include but are not limited to the followings:
• Patients with uncontrolled hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg under regular drug control); Patients with hypertensive crisis or had a history of hypertensive encephalopathy; Cerebrovascular accidents, transient ischemic attacks and myocardial infarction within 6 months prior to treatment with the study drug, and significant vascular disease (including, but not limited to, aortic aneurysms or proximal arterial thrombosis requiring surgical repair); Unstable angina; Heart failure (NYHA ≥Ⅱ) Uncontrolled serious arrhythmia by drug (ECG QTc ≥450ms for male, and QTc≥470ms for female, calculated by Fridericia formula)
• Patients with thrombotic dysfunction: International standardized ratio (INR) or activated partial thromboplastin time APTT, any of which ≥1.5×ULN
• Patients who are known to be allergic to the study drug or its excipients, or have a history of severe allergies to other monoclonal antibodies
• Patients who are in pregnant or breastfeeding, or are unable to use reliable contraception during the study and 6 months after discontinued treatmen

Sponsors & Collaborators

• Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

jianming XU, Doctor

CONTACT

86+13910866712; Jianmingxu2014@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 10, 2020
• Study Start: December 7, 2020
• Primary Completion: December 30, 2021
• Study Completion: March 30, 2022
• Last Updated: August 23, 2021

Record last verified: 2021-08

Locations

CN (1)