Metastatic Colorectal CancerPhase 1NCT03356158
A Study of Recombinant Anti-EGFR Monoclonal Antibody in Patients With Metastatic Colorectal Cancer
A Phase 1 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
This is an open-label, parallel designed study to assess the pharmacokinetics, safety and tolerability of the single-dose and multi-dose of a recombinant anti-EGFR monoclonal antibody (CPGJ602) in patients with at least one prior chemical regimen failed metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 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
- 21 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2017to 30 Nov 2018
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years old, male or female.
- Histologically or cytologically confirmed metastatic CRC, and have failed (disease progression or intolerance) at least one prior chemical regimen containing oxaliplatin, irinotecan or 5-FU, etc.
- ECOG performance status 0 or 1.
- Estimated life expectancy ≥ 3 months.
- RAS (including K-ras and N-ras) wide type status.
- Adequate bone marrow, hepatic and renal functions. Hematopoietic:
Show all 9Show fewer
- Leukocytes (WBC)>4.0×109/L or Absolute Neutrophil Count (ANC)> 1.5×109/L, Platelet Count (PLT)>80×109/L, Hemoglobin (Hb)>90g/ L; Hepatic: Total Bilirubin (T-Bil)≤1.5×ULT (Upper Limit of Normal), Alanine Transaminase (ALT)/ Aspartate Transaminase (AST)≤2.5×ULT or ≤5×ULT in case of liver metastases; Renal: Blood Urea Nitrogen (BUN)≤1.5×ULT, Serum Creatinine (Cr) ≤ 1.5×ULT.
- At least one measurable disease based on RECIST criteria (v 1.1).
- Signed informed consent on a voluntary basis at screening, and no geographical condition that would preclude the study compliance.
Who cannot join
- Less than 28 days since prior chemotherapy, radiotherapy or surgery (diagnosis biopsy is allowed).
- Previous epidermal growth factor receptor (EGFR) targeted therapies (including monoclonal antibody, tyrosine kinase inhibitor [TKI] and other EGFR targeted therapies, such as cetuximab, nimotuzumab, panitumumab, gefitinib, erlotinib, and icotinib, etc.
- Known hypersensitivity to study drugs or any of the excipients.
- Known or clinical suspected brain metastases and/or disease of meninges.
- Clinically significant cardiovascular or cerebrovascular dis ease, history of myocardial infarction (MI) in the latest 6 months, or high-risk of uncontrolled cardiac arrhythmias.
- History of acute or sub-acute intestinal obstruction, or of inflammatory bowel disease.
Show all 10Show fewer
- A serious and uncontrolled concomitant disease which, in the investigator's opinion, rules out the patient's participation in the study, such as history of malignancies other than CRC (with the exception of: curatively treated carcinoma of the skin [except for melanoma]; cured cervical cancer or basal cell skin cancer, ductal carcinoma in situ [DICS], endometrial carcinoma [stage I grade 1]; and other solid tumors including lymphoma without bone marrow infiltration for which the patient has been disease-free for 5 years), uncontrolled hypertension, diabetes mellitus (DM), peripheral neuropathy, and infectious diseases (including viral, bacterial and parasitic infections), etc.
- Pregnancy or lactation, or a fertility plan during the participation in this study.
- No more than 4 weeks or no more than 5 times of t1/2 since prior investigational agents.
- Other situations that impede the patient's participation in the study at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310020
Hongming Pan, Doctor, 0571-86006922, shonco@sina.cn
About this study
Official title: A Phase 1 Study of Recombinant Anti-Epidermal Growth Factor Receptor (EGFR) Human-mouse Chimeric Monoclonal Antibody Injection in Patients With Metastatic Colorectal Cancer
This is an open-label, parallel designed study to assess the pharmacokinetics, safety and tolerability of the single-dose and multi-dose of a recombinant anti-EGFR monoclonal antibody (CPGJ602) in patients with at least one prior chemical regimen failed metastatic colorectal cancer. The immunogenicity and preliminary efficacy of CPGJ602 will also be assessed. The study includes 3 parts: part 1: after a single dose of CPGJ602 or cetuximab (the active comparator), the patients will be observed for 4 weeks; part 2: CPGJ602 or cetuximab will be administered to the patients once a week for 5 weeks; part 3: CPGJ602 will be administered to the patients once a week until the patient's death or the withdrawal decision of the patient and/or investigator.
Read the detailed description
OBJECTIVES:
Primary:
To assess the pharmacokinetics, safety and tolerability of the single-dose and multi-dose of CPGJ602 administered by intravenous infusion.
Secondary:
To assess the immunogenicity and anti-tumor activity of CPGJ602, compare the pharmacokinetics and immunogenicity between CPGJ602 and the active comparator, cetuximab, and to provide scientific basis for the subsequent phase 2/3 clinical trials.
OUTLINE:
This is an open-label, parallel designed study in patients with at least one prior chemical regimen failed metastatic colorectal cancer. The study can be divided into 3 parts:
Part 1: Single-dose Part
- Arm A: CPGJ602, IV over 2 hours, 100 mg/m2 X 1;
- Arm B: CPGJ602, IV over 2 hours, 400 mg/m2 X 1;
- Arm C: Cetuximab, IV over 2 hours, 400 mg/m2 X 1.
Part 2: Multi-dose Part
The subjects from arm A in Part 1 will be randomized into arm B or C.
- Arm B: CPGJ602, IV, QW, 400 mg/m2 X 1, over 2 hours, followed by 250mg/m2 X4, over 1 hour for each time;
- Arm C: Cetuximab, IV, QW, 400 mg/m2 X 1, over 2 hours, followed by 250mg/m2 X4, over 1 hour for each time. The completion of Day 63 Visit (the visit on the 7th day after the 5th dose in Part 2) can be considered as the completion of the study.
Part 3 (Follow-up Part)
CPGJ602, IV over 1 hour, QW, 250mg/m2, until the patient's death or the withdrawal decision of the patient and/or investigator.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- CPGJ602, Cetuximab
- Keywords
- Metastatic Colorectal Cancer,, Recombinant Anti-EGFR Monoclonal Antibody
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPGJ602Biological
Injection, q.w., 20 mg: 100 ml
CetuximabBiological
Injection, q.w., 20 mg: 100 ml
| Study group | Role | What they receive |
|---|---|---|
| CPGJ 602 low dose | Experimental | Part 1: CPGJ602, IV over 2 hours, 100 mg/m2 X 1; Receives: Biological: CPGJ602 |
| CPGJ 602 normal dose | Experimental | Part 1: CPGJ602, IV over 2 hours, 400 mg/m2 X 1; Part 2: CPGJ602, IV, QW, 400 mg/m2 X 1, over 2 hours, followed by 250mg/m2 X4, over 1 hour for each time; Receives: Biological: CPGJ602 |
| Cetuximab normal dose | Active comparator | Part 1: Cetuximab, IV over 2 hours, 400 mg/m2 X 1. Part 2: Cetuximab, IV, QW, 400 mg/m2 X 1, over 2 hours, followed by 250mg/m2 X4, over 1 hour for each time. Receives: Biological: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration [Cmax]
part 1 for single dose and part 2 for multiple doses
Measured: Day 0 - Day 21 for single dose and Day 28 - Day 63 for multiple doses
Half life of CPGJ602 in blood [t1/2]
part 1 for single dose and part 2 for multiple doses
Measured: Day 0 - Day 21 for single dose and Day 28 - Day 63 for multiple doses
Area Under the Curve [AUC]
part 1 for single dose and part 2 for multiple doses
Measured: Day 0 - Day 21 for single dose and Day 28 - Day 63 for multiple doses
Incidence of Adverse Events [AEs]
to evaluate the safety and tolerability
Measured: Day -28 to 1 month following the last administration
Secondary outcomes (4)
Anti-Drug Antibody [ADA]
to evaluate the Immunogenicity; if the result is positive, Neutralizing Antibody [NAB] will also be assessed.
Measured: Day 0 to Day 63, and in the follow-up period.
Objective Response Rate [ORR]
the rate of completely response [CR] and partial response [PR] patients
Measured: Day -28 - Day 63
Carcinoembryonic antigen [CEA]
Tumor Marker
Measured: Day -28 - Day 63
Cancer antigen [CA19-9]
Tumor Marker
Measured: Day -28 - Day 63
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start15 Nov 2017
- Primary completion30 Oct 2018 (estimated)
- Study completion30 Nov 2018 (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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianming Xu, Doctor, Principal investigator, the Afflicated Hospital of Academy of Military Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356158
- Sponsor's protocol ID
- CPGJ602-001
- Status last verified
- Nov 2017
- First submitted
- 9 Nov 2017
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Recombinant Anti-Epidermal Growth Factor Receptor (EGFR) Human-mouse Chimeric Monoclonal Antibody Injection in Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03356158
- Acronym / sponsor ID
- CPGJ602-001
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Metastatic Colorectal Cancer,, Recombinant Anti-EGFR Monoclonal Antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 30 Oct 2018 (estimated)
- Study completion
- 30 Nov 2018 (estimated)
- First posted
- 29 Nov 2017 (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.
This is an open-label, parallel designed study to assess the pharmacokinetics, safety and tolerability of the single-dose and multi-dose of a recombinant anti-EGFR monoclonal antibody (CPGJ602) in patients with at least one prior chemical regimen failed metastatic colorectal cancer. The immunogenicity and preliminary efficacy of CPGJ602 will also be assessed. The study includes 3 parts: part 1: after a single dose of CPGJ602 or cetuximab (the active comparator), the patients will be observed for 4 weeks; part 2: CPGJ602 or cetuximab will be administered to the patients once a week for 5 weeks; part 3: CPGJ602 will be administered to the patients once a week until the patient's death or the withdrawal decision of the patient and/or investigator.
Detailed description
OBJECTIVES:
Primary:
To assess the pharmacokinetics, safety and tolerability of the single-dose and multi-dose of CPGJ602 administered by intravenous infusion.
Secondary:
To assess the immunogenicity and anti-tumor activity of CPGJ602, compare the pharmacokinetics and immunogenicity between CPGJ602 and the active comparator, cetuximab, and to provide scientific basis for the subsequent phase 2/3 clinical trials.
OUTLINE:
This is an open-label, parallel designed study in patients with at least one prior chemical regimen failed metastatic colorectal cancer. The study can be divided into 3 parts:
Part 1: Single-dose Part
- Arm A: CPGJ602, IV over 2 hours, 100 mg/m2 X 1;
- Arm B: CPGJ602, IV over 2 hours, 400 mg/m2 X 1;
- Arm C: Cetuximab, IV over 2 hours, 400 mg/m2 X 1.
Part 2: Multi-dose Part
The subjects from arm A in Part 1 will be randomized into arm B or C.
- Arm B: CPGJ602, IV, QW, 400 mg/m2 X 1, over 2 hours, followed by 250mg/m2 X4, over 1 hour for each time;
- Arm C: Cetuximab, IV, QW, 400 mg/m2 X 1, over 2 hours, followed by 250mg/m2 X4, over 1 hour for each time. The completion of Day 63 Visit (the visit on the 7th day after the 5th dose in Part 2) can be considered as the completion of the study.
Part 3 (Follow-up Part)
CPGJ602, IV over 1 hour, QW, 250mg/m2, until the patient's death or the withdrawal decision of the patient and/or investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CPGJ 602 low dose | Experimental | Biological: CPGJ602Part 1: CPGJ602, IV over 2 hours, 100 mg/m2 X 1; |
| CPGJ 602 normal dose | Experimental | Biological: CPGJ602Part 1: CPGJ602, IV over 2 hours, 400 mg/m2 X 1; Part 2: CPGJ602, IV, QW, 400 mg/m2 X 1, over 2 hours, followed by 250mg/m2 X4, over 1 hour for each time; |
| Cetuximab normal dose | Active comparator | Biological: CetuximabPart 1: Cetuximab, IV over 2 hours, 400 mg/m2 X 1. Part 2: Cetuximab, IV, QW, 400 mg/m2 X 1, over 2 hours, followed by 250mg/m2 X4, over 1 hour for each time. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18-70 years old, male or female.
- Histologically or cytologically confirmed metastatic CRC, and have failed (disease progression or intolerance) at least one prior chemical regimen containing oxaliplatin, irinotecan or 5-FU, etc.
- ECOG performance status 0 or 1.
- Estimated life expectancy ≥ 3 months.
- RAS (including K-ras and N-ras) wide type status.
Key exclusion criteria (10 listed)
- Less than 28 days since prior chemotherapy, radiotherapy or surgery (diagnosis biopsy is allowed).
- Previous epidermal growth factor receptor (EGFR) targeted therapies (including monoclonal antibody, tyrosine kinase inhibitor [TKI] and other EGFR targeted therapies, such as cetuximab, nimotuzumab, panitumumab, gefitinib, erlotinib, and icotinib, etc.
- Known hypersensitivity to study drugs or any of the excipients.
- Known or clinical suspected brain metastases and/or disease of meninges.
- Clinically significant cardiovascular or cerebrovascular dis ease, history of myocardial infarction (MI) in the latest 6 months, or high-risk of uncontrolled cardiac arrhythmias.
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 |
|---|---|---|
| CPGJ602Injection, q.w., 20 mg: 100 ml | Biological | CPGJ 602 low dose, CPGJ 602 normal dose |
| CetuximabInjection, q.w., 20 mg: 100 ml | Biological | Cetuximab normal dose |
Primary outcome
Maximum Plasma Concentration [Cmax]
Time frame: Day 0 - Day 21 for single dose and Day 28 - Day 63 for multiple doses
part 1 for single dose and part 2 for multiple doses
Half life of CPGJ602 in blood [t1/2]
Time frame: Day 0 - Day 21 for single dose and Day 28 - Day 63 for multiple doses
part 1 for single dose and part 2 for multiple doses
Area Under the Curve [AUC]
Time frame: Day 0 - Day 21 for single dose and Day 28 - Day 63 for multiple doses
part 1 for single dose and part 2 for multiple doses
Incidence of Adverse Events [AEs]
Time frame: Day -28 to 1 month following the last administration
to evaluate the safety and tolerability
4 secondary outcomes
Anti-Drug Antibody [ADA]
Time frame: Day 0 to Day 63, and in the follow-up period.
Objective Response Rate [ORR]
Time frame: Day -28 - Day 63
Carcinoembryonic antigen [CEA]
Time frame: Day -28 - Day 63
Cancer antigen [CA19-9]
Time frame: Day -28 - Day 63
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Metastatic Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
CRC
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.
Jianming Xu, Doctor principal investigator
the Afflicated Hospital of Academy of Military Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 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 9 inclusion and 10 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 17 Sep 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Quanrui Wu, Master (13601126093, wuquanrui@3sbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration [Cmax] (time frame: Day 0 - Day 21 for single dose and Day 28 - Day 63 for multiple doses). The study lists 4 primary outcomes in all. 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 17 Sep 2018.