Colorectal CancerPhase 1NCT03491709
A Preliminary Clinical Study on the Pharmacokinetics and Safety of CDP1 in Patients With Advanced CRC or HNSCC
A Phase 1 study testing anti-EGFR monoclonal antibody and Cetuximab injection in people with Colorectal Cancer, run by Dragonboat Biopharmaceutical Company Limited at 1 site in China.
Trial summary
Colorectal cancer (CRC) is one of the most common human malignant tumors. The incidence and mortality of colorectal cancer in our country are on the rise. Surgery-based, combined with chemotherapy, radiotherapy comprehensive treatment, is the main treatment of colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- anti-EGFR monoclonal antibody and Cetuximab injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 18 Sep 2019
- 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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 ~ 75 (inclusive) years , male.
- Histologically or cytologically confirmed ras genotype is wild-type patients with advanced metastatic colorectal cancer, at least second-line chemotherapy (including oxaliplatin, irinotecan and fluorouracil drugs) failed, or intolerant to Irinotecan or chemotherapy-denied patients.
- ECOG physical score 0-2 points.
- Expected survival time of 3 months or more.
- According to RECIST 1.1, there is at least one assessable tumor lesion.
- No serious hematological system, liver function, renal function and coagulation dysfunction:Neutrophils ≥1.5 × 109 / L, platelets ≥75 × 109 / L, hemoglobin≥90g / L; total bilirubin≤1.5 times ULN, alanine aminotransferase (ALT)≤2.5 times ULN,aspartate transaminase (AST) ≤2.5 times ULN (liver metastasis ALT ≤ 5 times ULN, AST≤ 5 times ULN);Serum creatinine ≤1.5 times ULN;Activated partial thromboplastin time (APTT) ≤1.5 times ULN, prothrombin time (PT) ≤1.5 times ULN, international normalized ratio (INR) ≤1.5 times ULN.
- Eligible patients with fertility must agree to use reliable methods of contraception (hormonal or barrier abstinence) for at least 12 weeks during and after the last dose of medication.
- Subjects should be informed of the study prior to the test and voluntarily sign a written informed consent form.
Who cannot join
- Chemotherapy, biotherapy, radiation therapy, endocrine therapy, small molecule targeted therapies and other anti-tumor, etc. within 4 weeks prior to the start of study drug use or within 5 half-lives of the known drug (whichever is longer) Anti-cancer therapy, or other experimental drug treatment (except nitrosourea, mitomycin C and fluorouracil oral drugs),nitrosourea or mitomycin C for 6 weeks. Fluorouracil-based oral medications, such as tiotropium and capecitabine, have an interval of at least 2 weeks between the last oral dose and study drug use.
- Have previously received anti-EGFR monoclonal antibody treatment.
- EGFR antibody drug-resistant antibody (ADA) positive.
- Within 3 months prior to enrollment, major organ surgery (excluding biopsy) or significant trauma occurred.
- The adverse reactions of previous anti-tumor therapy have not been restored to CTCAE 4.03 grade ≤1 (excluding hair loss).
- Untreated or clinically symptomatic brain metastases, spinal cord compression, cancerous meningitis, or other evidence that the patient's brain, spinal metastases have not yet been controlled, the researchers judged not suitable for inclusion. clinical symptoms suspected brain or soft Membrane disease is to be ruled out by CT / MRI examination.
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- Uncontrolled active infections.
- Have a history of immunodeficiency, including HIV antibody test positive.
- Treponema anti-positive.
- Chronic hepatitis B virus (HBV) infection; Hepatitis C virus (HCV) infection.
- Serious history of cardiovascular disease: including ventricular arrhythmias requiring clinical intervention; acute coronary syndromes, congestive heart failure, stroke or other cardiovascular events of grade III and higher within 6 months; New York, USA Heart Association (NYHA. Cardiac function grade ≥II or Left ventricular ejection fraction(LVEF) <50%; poorly controlled hypertension (systolic blood pressure> 150 mmHg, diastolic blood pressure> 90 mmHg).
- Interstitial lung disease.
- There are other serious history of systemic diseases, the researchers judged not suitable for clinical trials of patients.
- Alcohol or drug dependence is known.
- Persons with mental disorders or poor compliance.
- Moderate or severe infusion-related reactions, including anaphylaxis, have been reported in the past when using monoclonal antibody drugs.
- The investigators did not find it appropriate to participate in this clinical study because of any clinical or laboratory abnormalities or other causes.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai East Hospital Phase 1 Clinical Trial Center
Shanghai, Shanghai Municipality, 201203
About this study
Official title: A Preliminary Clinical Study on the Pharmacokinetics and Safety of Recombinant Anti-EGFR Human Mouse Chimeric Monoclonal Antibody Injection (CDP1) in Patients With Advanced Colorectal Cancer or Head and Neck Squamous Cell Carcinoma
Colorectal cancer (CRC) is one of the most common human malignant tumors. The incidence and mortality of colorectal cancer in our country are on the rise. Surgery-based, combined with chemotherapy, radiotherapy comprehensive treatment, is the main treatment of colorectal cancer. Surgical resection has been recognized as the primary treatment of colorectal cancer. However, due to the majority of patients already advanced at the time of diagnosis, some difficulties are brought to radical surgery. Therefore, the importance of chemotherapy for colorectal cancer gradually been clinically recognized, But rarely survive more than 18 months." In addition to chemotherapy, there is now a more ideal model of cancer treatment- molecular targeted therapies, including monoclonal antibody drugs such as cetuximab, as well as small molecule tyrosine kinases Inhibitors gefitinib and so on. Molecular targeted drugs make use of the difference in molecular biology between tumor cells and normal cells. Targeting drugs to tumor cells and inhibiting the growth and proliferation of the cells can achieve the therapeutic effect, which has the advantages of high specificity and low adverse reaction. The bio-targeted drug cetuximab is the first drug approved to marketed as an epidermal growth factor receptor (EGFR)-targeting immunoglobulin 1（IgG1）monoclonal antibody. Cetuximab, either monotherapy or combined radiotherapy and chemotherapy, can exert excellent anti-tumor activity in EGFR-positive malignant tumors and can significantly enhance the efficacy of radiotherapy and chemotherapy.
Reference to cetuximab injection, guilin sanjin Co., Ltd. and dragonboat Co., Ltd. jointly developed a recombinant anti-EGFR human mouse chimeric monoclonal antibody (R \& D code: CDP1).The primary structure of CDP1 is exactly the same with cetuximab, the higher structure and Physical and chemical properties and cetuximab are highly similar. Pharmacodynamic activity in vivo and in vitro, pharmacokinetic characteristics and toxicological reactions are also similar to cetuximab. CDP1 selected with cetuximab consistent formulations, prescriptions, specifications.
CDP1 was approved by China Food and Drug Administration (No. 2016L06884) in August 2016 for clinical studies. According to the contents of the document and guidelines for biological analogs, the clinical pharmacokinetic and clinical effectiveness comparison tests of CDP1 and the safety and immunogenicity assessment are planned.
Read the detailed description
OBJECTIVES:
Primary:
To compare the pharmacokinetic characteristics of a single dose between CDP1 and the original drug Erbitux In patients with advanced metastatic colorectal cancer.
Secondary :
- To compare the safety and immunogenic characteristics of the single dose between CDP1 and the original drug Erbitux in patients with advanced metastatic colorectal cancer.
- To evaluate the pharmacokinetics and safety of CDP1 multiple administrations."
OUTLINE
The study can be divided into 3 parts:
Part 1: Single-dose Phase:
single center, parallel, randomized, single-blind trial. The original drug Erbitux as a control, CDP1 and Erbitux single-dose pharmacokinetics of the initial comparison, and at the same time safety and immunogen preliminary comparison. CDP1 group received a single administration of CDP1 250mg/m2, Erbitux group received Erbitux 250mg/m2 single administration. Two groups of subjects after a single administration into the 4-week observation period, safety observations, pharmacokinetic blood samples and immunogenic blood samples were collected. The tumor was evaluated at the end of the 4 week observation period.If the subjects did not develop the disease, or did not appear the intolerant toxicity during the observation period, they entered the period of multiple drug delivery.
Part 2: Multi-dose Phase:
Single center, single arm, open trial, evaluation of pharmacokinetics and safety with multiple doses of CDP1. Multiple administrations of two groups of subjects were followed by continuous administration of CDP1. Dosing regimen is the first administration of 400mg/m2, followed by 250mg/m2, once a week for 6 weeks.
Part 3: Follow-up Phase:
CDP1, IV, once a week, 250mg/m2, until the patient's death or the withdrawal decision of the patient and/or investigator.
- Conditions
- Colorectal Cancer
- Being tested
- anti-EGFR monoclonal antibody, Cetuximab injection
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-EGFR monoclonal antibodyDrug
Also called CDP1
Recombinant anti-EGFR human mouse chimeric monoclonal antibody injection
Cetuximab injectionDrug
Also called Erbitux
Cetuximab injection
| Study group | Role | What they receive |
|---|---|---|
| anti-EGFR monoclonal antibody | Experimental | Recombinant anti-EGFR human mouse chimeric monoclonal antibody injection 250mg/m2 single administration Receives: Drug: anti-EGFR monoclonal antibody |
| Cetuximab injection | Active comparator | Cetuximab,Erbitux 250mg/m2 single administration Receives: Drug: Cetuximab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Parameters: Area Under the Serum Concentration-time Curve From Time Zero to the Last Sampling Time (AUC0-t) After First Infusion
Single-dose Phase: Pharmacokinetic parameters: AUC(0-t) for CDP1
Measured: Up to 59 Days
Secondary outcomes (15)
Pharmacokinetic parameters: Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-00) After First Infusion
Single-dose Phase: Pharmacokinetic parameters: AUC(0-00) for CDP1
Measured: Up to 59 Days
Pharmacokinetic parameters: Observed Maximum Serum Concentration (Cmax) of CDP1 After First Infusion
Single-dose Phase: Pharmacokinetic parameters Cmax for CDP1
Measured: Up to 59 Days
Pharmacokinetic parameters: Mean Residence Time of Drug in the Body (MRT) of CDP1 After First Infusion
Single-dose Phase: Pharmacokinetic parameters MRT for CDP1
Measured: Up to 59 Days
Pharmacokinetic parameters: Apparent Terminal Half-life (t1/2) of CDP1 After First Infusion
Single-dose Phase: Pharmacokinetic parameters T1/2 for CDP1
Measured: Up to 59 Days
Pharmacokinetic parameters: Total Body Clearance of Drug From Serum (CL) After First Infusion
Single-dose Phase: Pharmacokinetic parameters CL for CDP1
Measured: Up to 59 Days
Vital signs: Blood pressure
Vital signs: Blood pressure
Measured: Up to 73 Days
Vital signs: Pulse rate
Vital signs: Pulse rate
Measured: Up to 73 Days
Vital signs: Respiratory rate
Vital signs: Respiratory rate
Measured: Up to 73 Days
Physical examination: height
Physical examination: height
Measured: Up to 73 Days
Physical examination: Weigh
Physical examination: Weigh
Measured: Up to 73 Days
Number of Subjects With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Worst Post-baseline Score
ECOG performance status measured to assess subject's performance status on a scale of 0 to 4, where 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair >50% of waking hours; 4=Completely disabled, cannot carry on any self-care, totally confined to bed/chair. ECOG performance status was reported in terms of number of subjects with Baseline value vs. worst post-baseline value (i.e. highest score) combination.
Measured: Up to 73 Days
Number of Subjects With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Best Post-baseline Score
ECOG performance status measured to assess subject's performance status on a scale of 0 to 4, where 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair >50% of waking hours; 4=Completely disabled, cannot carry on any self-care, totally confined to bed/chair. ECOG performance status was reported in terms of number of subjects with Baseline value vs. best post-baseline value (i.e. lowest score) combination.
Measured: Up to 73 Days
Frequency of adverse events (AE)
Frequency of adverse events (AE)
Measured: Up to 59 Days
Immunogenicity indicators: Anti-drug antibodies (ADA) .
Immunogenicity indicators: Anti-drug antibodies (ADA) .
Measured: Up to 73 Days
Immunogenicity indicators: neutralizing antibodies
Immunogenicity indicators: neutralizing antibodies (Titers and Nab analyzes will be performed when ADA screening is positive).
Measured: Up to 73 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start1 Jul 2018
- Primary completion18 Sep 2019
- Study completion18 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dragonboat Biopharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai East Hospital
- Responsible party
- Sponsor
- Investigators
- Li Jin, doctor, Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491709
- Sponsor's protocol ID
- CDP100001
- Status last verified
- Sep 2019
- First submitted
- 21 Mar 2018
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Clinical Study on the Pharmacokinetics and Safety of Recombinant Anti-EGFR Human Mouse Chimeric Monoclonal Antibody Injection (CDP1) in Patients With Advanced Colorectal Cancer or Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03491709
- Acronym / sponsor ID
- CDP100001
- Conditions
- Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Dragonboat Biopharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai East Hospital
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 18 Sep 2019 (actual)
- Study completion
- 18 Sep 2019 (actual)
- First posted
- 9 Apr 2018 (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.
Colorectal cancer (CRC) is one of the most common human malignant tumors. The incidence and mortality of colorectal cancer in our country are on the rise. Surgery-based, combined with chemotherapy, radiotherapy comprehensive treatment, is the main treatment of colorectal cancer. Surgical resection has been recognized as the primary treatment of colorectal cancer. However, due to the majority of patients already advanced at the time of diagnosis, some difficulties are brought to radical surgery. Therefore, the importance of chemotherapy for colorectal cancer gradually been clinically recognized, But rarely survive more than 18 months." In addition to chemotherapy, there is now a more ideal model of cancer treatment- molecular targeted therapies, including monoclonal antibody drugs such as cetuximab, as well as small molecule tyrosine kinases Inhibitors gefitinib and so on. Molecular targeted drugs make use of the difference in molecular biology between tumor cells and normal cells. Targeting drugs to tumor cells and inhibiting the growth and proliferation of the cells can achieve the therapeutic effect, which has the advantages of high specificity and low adverse reaction. The bio-targeted drug cetuximab is the first drug approved to marketed as an epidermal growth factor receptor (EGFR)-targeting immunoglobulin 1（IgG1）monoclonal antibody. Cetuximab, either monotherapy or combined radiotherapy and chemotherapy, can exert excellent anti-tumor activity in EGFR-positive malignant tumors and can significantly enhance the efficacy of radiotherapy and chemotherapy.
Reference to cetuximab injection, guilin sanjin Co., Ltd. and dragonboat Co., Ltd. jointly developed a recombinant anti-EGFR human mouse chimeric monoclonal antibody (R \& D code: CDP1).The primary structure of CDP1 is exactly the same with cetuximab, the higher structure and Physical and chemical properties and cetuximab are highly similar. Pharmacodynamic activity in vivo and in vitro, pharmacokinetic characteristics and toxicological reactions are also similar to cetuximab. CDP1 selected with cetuximab consistent formulations, prescriptions, specifications.
CDP1 was approved by China Food and Drug Administration (No. 2016L06884) in August 2016 for clinical studies. According to the contents of the document and guidelines for biological analogs, the clinical pharmacokinetic and clinical effectiveness comparison tests of CDP1 and the safety and immunogenicity assessment are planned.
Detailed description
OBJECTIVES:
Primary:
To compare the pharmacokinetic characteristics of a single dose between CDP1 and the original drug Erbitux In patients with advanced metastatic colorectal cancer.
Secondary :
- To compare the safety and immunogenic characteristics of the single dose between CDP1 and the original drug Erbitux in patients with advanced metastatic colorectal cancer.
- To evaluate the pharmacokinetics and safety of CDP1 multiple administrations."
OUTLINE
The study can be divided into 3 parts:
Part 1: Single-dose Phase:
single center, parallel, randomized, single-blind trial. The original drug Erbitux as a control, CDP1 and Erbitux single-dose pharmacokinetics of the initial comparison, and at the same time safety and immunogen preliminary comparison. CDP1 group received a single administration of CDP1 250mg/m2, Erbitux group received Erbitux 250mg/m2 single administration. Two groups of subjects after a single administration into the 4-week observation period, safety observations, pharmacokinetic blood samples and immunogenic blood samples were collected. The tumor was evaluated at the end of the 4 week observation period.If the subjects did not develop the disease, or did not appear the intolerant toxicity during the observation period, they entered the period of multiple drug delivery.
Part 2: Multi-dose Phase:
Single center, single arm, open trial, evaluation of pharmacokinetics and safety with multiple doses of CDP1. Multiple administrations of two groups of subjects were followed by continuous administration of CDP1. Dosing regimen is the first administration of 400mg/m2, followed by 250mg/m2, once a week for 6 weeks.
Part 3: Follow-up Phase:
CDP1, IV, once a week, 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
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anti-EGFR monoclonal antibody | Experimental | Drug: anti-EGFR monoclonal antibodyRecombinant anti-EGFR human mouse chimeric monoclonal antibody injection 250mg/m2 single administration |
| Cetuximab injection | Active comparator | Drug: Cetuximab injectionCetuximab,Erbitux 250mg/m2 single administration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 ~ 75 (inclusive) years , male.
- Histologically or cytologically confirmed ras genotype is wild-type patients with advanced metastatic colorectal cancer, at least second-line chemotherapy (including oxaliplatin, irinotecan and fluorouracil drugs) failed, or intolerant to Irinotecan or chemotherapy-denied patients.
- ECOG physical score 0-2 points.
- Expected survival time of 3 months or more.
- According to RECIST 1.1, there is at least one assessable tumor lesion.
Key exclusion criteria (17 listed)
- Chemotherapy, biotherapy, radiation therapy, endocrine therapy, small molecule targeted therapies and other anti-tumor, etc. within 4 weeks prior to the start of study drug use or within 5 half-lives of the known drug (whichever is longer) Anti-cancer therapy, or other experimental drug treatment (except nitrosourea, mitomycin C and fluorouracil oral drugs),nitrosourea or mitomycin C for 6 weeks. Fluorouracil-based oral medications, such as tiotropium and capecitabine, have an interval of at least 2 weeks between the last oral dose and study drug use.
- Have previously received anti-EGFR monoclonal antibody treatment.
- EGFR antibody drug-resistant antibody (ADA) positive.
- Within 3 months prior to enrollment, major organ surgery (excluding biopsy) or significant trauma occurred.
- The adverse reactions of previous anti-tumor therapy have not been restored to CTCAE 4.03 grade ≤1 (excluding hair loss).
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 |
|---|---|---|
| anti-EGFR monoclonal antibodyAlso: CDP1Recombinant anti-EGFR human mouse chimeric monoclonal antibody injection | Drug | anti-EGFR monoclonal antibody |
| Cetuximab injectionAlso: ErbituxCetuximab injection | Drug | Cetuximab injection |
Primary outcome
Pharmacokinetic Parameters: Area Under the Serum Concentration-time Curve From Time Zero to the Last Sampling Time (AUC0-t) After First Infusion
Time frame: Up to 59 Days
Single-dose Phase: Pharmacokinetic parameters: AUC(0-t) for CDP1
15 secondary outcomes
Pharmacokinetic parameters: Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-00) After First Infusion
Time frame: Up to 59 Days
Pharmacokinetic parameters: Observed Maximum Serum Concentration (Cmax) of CDP1 After First Infusion
Time frame: Up to 59 Days
Pharmacokinetic parameters: Mean Residence Time of Drug in the Body (MRT) of CDP1 After First Infusion
Time frame: Up to 59 Days
Pharmacokinetic parameters: Apparent Terminal Half-life (t1/2) of CDP1 After First Infusion
Time frame: Up to 59 Days
Pharmacokinetic parameters: Total Body Clearance of Drug From Serum (CL) After First Infusion
Time frame: Up to 59 Days
Vital signs: Blood pressure
Time frame: Up to 73 Days
Vital signs: Pulse rate
Time frame: Up to 73 Days
Vital signs: Respiratory rate
Time frame: Up to 73 Days
Physical examination: height
Time frame: Up to 73 Days
Physical examination: Weigh
Time frame: Up to 73 Days
Number of Subjects With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Worst Post-baseline Score
Time frame: Up to 73 Days
Number of Subjects With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Best Post-baseline Score
Time frame: Up to 73 Days
Frequency of adverse events (AE)
Time frame: Up to 59 Days
Immunogenicity indicators: Anti-drug antibodies (ADA) .
Time frame: Up to 73 Days
Immunogenicity indicators: neutralizing antibodies
Time frame: Up to 73 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Li Jin, doctor principal investigator
Shanghai East Hospital
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 anti-EGFR monoclonal antibody and Cetuximab injection in people with Colorectal Cancer, run by Dragonboat Biopharmaceutical Company Limited 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 8 inclusion and 17 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: finished, as of the sponsor's last update on 6 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Parameters: Area Under the Serum Concentration-time Curve From Time Zero to the Last Sampling Time (AUC0-t) After First Infusion (time frame: Up to 59 Days). 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 6 Jul 2026.