Metastatic Colorectal CancerPhase 2NCT04466254
Efficacy and Safety Study of Combination of CPGJ602 and Chemotherapy, in First Line, With Wild KRAS/NRAS/BRAF in Metastatic Colorectal Cancer
A Phase 2 study testing CPGJ602 and cetuximab in people with Metastatic Colorectal Cancer, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- CPGJ602 and cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 7 Dec 2020to 30 Mar 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
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- 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
Who cannot join
- 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
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- 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
- Patients received any experimental drug in other interventional clinical trials: the time from stopping taking the study drug of a previous treatment to take the first dose of this study drug is less than 28 days or less than 5 half-lives of the drug, whichever is longer
- Patients who have a history of organ transplant, including autologous/allogeneic stem cell transplantation
- Patients who have a history of severe dry eye and Patients who Currently suffering from severe dry eye disease , keratitis,and ulcerative keratitis.
- Other conditions which are not fit for this study assessed by investigator
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality
jianming xu, Doctor
About this study
Official title: A Phase II Study Evaluating the Efficacy and Safety of Combination of CPGJ602 and Chemotherapy as First Line Treatment in KRAS/NRAS/BRAF Wild-type, Metastatic Colorectal Cancer Patients
To assess the efficacy and safety of the combination of CPGJ602 and chemotherapy in subjects with KRAS/NRAS/BRAF wild-type, metastatic colorectal cancer.
Read the detailed description
This is an open label, randomized, positive control, phase II study to treat subjects with KRAS/NRAS/BRAF wild-type, unresectable metastatic colorectal cancer. The patients will be randomized into three arms consist of CPGJ602 (2 weeks/cycle) + mFOLFOX6, CPGJ602 (1 week/cycle) + mFOLFOX6, and cetuximab (1 week/cycle) + mFOLFOX6 at a ratio of 2:2:1. This study is conduct to assess the efficacy and safety of three treatments for patients.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- CPGJ602, cetuximab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPGJ602Drug
Q2W/QW iv
cetuximabDrug
QW iv
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | CPGJ602 325mg/m2 IV Q2W； mFOLFOX6 therapy starts on day 1 and ends on day 2, then repeats every 2 weeks. Receives: 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 Receives: 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 Receives: Drug: cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: for 16 weeks
Secondary outcomes (6)
Progression Free Survival (PFS)
Defined as the interval from the date of randomization until first documented disease progression or death from any cause, whichever occurs first, assessed based on tumor assessments according to RECIST v1.1 per BICR and Investigator.
Measured: for 16 weeks
BOR Assessed by investigator
Measured: for 16 weeks
Disease Control Rate (DCR)
Defined as the percentage of patients whose overall response is CR, PR and SD from day 1 to 16th week and maintain at least until efficacy confirmation assessment (4 weeks ± 2 days), per RECIST v1.1 for target lesions assessed by BIRC and Investigator.
Measured: for 16 weeks
unConfirmed BOR at the end of 16th week by BICR and Investigator.
Defined as the percentage of patients whose overall response is CR or PR from day 1 to 16th week per RECIST v1.1 for target lesions assessed by BIRC and Investigator.
Measured: for 16 weeks
Time to Tumor Response (TTR)
Defined as the time from the first dose study treatment until the date of the first assessment of confirmed CR or PR, assessed by BICR and Investigator
Measured: for 16 weeks
Deepness of Response (DpR)
The relative change in the sum of longest diameters of RECIST target lesions at the nadir, in the absence of new lesions or progression of non-target lesions, when compared with baseline assessed by BIRC and Investigator
Measured: for 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start7 Dec 2020
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466254
- Sponsor's protocol ID
- SSGJ-602-mCRC-II-01
- Status last verified
- Aug 2021
- First submitted
- 6 Jul 2020
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Evaluating the Efficacy and Safety of Combination of CPGJ602 and Chemotherapy as First Line Treatment in KRAS/NRAS/BRAF Wild-type, Metastatic Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT04466254
- Acronym / sponsor ID
- SSGJ-602-mCRC-II-01
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy and safety of the combination of CPGJ602 and chemotherapy in subjects with KRAS/NRAS/BRAF wild-type, metastatic colorectal cancer.
Detailed description
This is an open label, randomized, positive control, phase II study to treat subjects with KRAS/NRAS/BRAF wild-type, unresectable metastatic colorectal cancer. The patients will be randomized into three arms consist of CPGJ602 (2 weeks/cycle) + mFOLFOX6, CPGJ602 (1 week/cycle) + mFOLFOX6, and cetuximab (1 week/cycle) + mFOLFOX6 at a ratio of 2:2:1. This study is conduct to assess the efficacy and safety of three treatments for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: CPGJ602CPGJ602 325mg/m2 IV Q2W； mFOLFOX6 therapy starts on day 1 and ends on day 2, then repeats every 2 weeks. |
| Arm B | Experimental | Drug: CPGJ602CPGJ602 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 |
| Arm C | Active comparator | Drug: cetuximabcetuximab 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (19 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPGJ602Q2W/QW iv | Drug | Arm A, Arm B |
| cetuximabQW iv | Drug | Arm C |
Primary outcome
Best of Response (BOR)
Time frame: for 16 weeks
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.
6 secondary outcomes
Progression Free Survival (PFS)
Time frame: for 16 weeks
BOR Assessed by investigator
Time frame: for 16 weeks
Disease Control Rate (DCR)
Time frame: for 16 weeks
unConfirmed BOR at the end of 16th week by BICR and Investigator.
Time frame: for 16 weeks
Time to Tumor Response (TTR)
Time frame: for 16 weeks
Deepness of Response (DpR)
Time frame: for 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CPGJ602 and cetuximab in people with Metastatic Colorectal Cancer, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jianming XU, Doctor (86+13910866712, Jianmingxu2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best of Response (BOR) (time frame: for 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021.