Solid TumorsPhase 1NCT02395068
Pharmacokinetics Study of Nimotuzumab in Patients With Solid Tumors
A Phase 1 study testing Nimotuzumab and Irinotecan in people with Solid Tumors, run by Biotech Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR), inhibiting tyrosine kinase activation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Nimotuzumab and Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Oct 2014
- 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
- Confirmed by pathology and / or cytology diagnosis in patients with advanced solid tumors
- Failure of first-line or multi-line chemotherapy and be suitable for irinotecan therapy
- Age 18-70 years, both genders at enrollment
- ECOG 0 to 1
- Adequate bone marrow function
- Recover from the toxicity of previous treatment
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- At least one measurable site of disease as defined by at least 20mm in greatest dimension by CT or 10mm in greatest dimension by SCT/MRI
- Male or female with fertility in the trial are willing to take contraceptive measures
- Estimated life expectancy of 3 months or greater
- All patients signed written informed consent
Who cannot join
- Have previously received EGFR-targeted therapy
- Current treatment on other effective programs
- Participated in other clinical trial within 4 weeks after enrollment
- Nervous system symptoms caused by brain metastases need to apply steroidal anti-edema medications to control
- Persistent uncontrollable diarrhea CTCAE 2 level and above (4-6 times daily)
- Complete or incomplete intestinal obstruction
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- Need to drainage pleural effusion and ascites
- Drug addiction and other adverse long-term alcoholics, as well as AIDS patients
- Occurred myocardial infarction within 6 months
- Diagnosed with severe interstitial pneumonitis or pulmonary fibrosis by Chest CT
- Severe or uncontrolled complications, such as infection required systemic treatment，fever（≥38℃），congestive heart failure，diabetes or hypertension that can not be controlled by drugs and other complications that may interfere with drug efficacy
- Drug allergy（≥CTCAE 3.0）, such as shock or allergy symptoms, especially allergic to similar drugs in the past and severe hypersensitivity to polysorbate eighty-containing drugs
- Uncontrollable seizures or loss of insight because of psychosis
- Female patient is pregnant, breastfeeding, or of childbearing potential but not take contraceptive measures
- Male patient who want his spouse to be pregnant during the trial
- Researchers believe that should not participate in this trial
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Institute & Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100000
About this study
Official title: Pharmacokinetics Study of Nimotuzumab Single-dose and Multiple-dose in Combination With Irinotecan in Patients With Solid Tumors
Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR), inhibiting tyrosine kinase activation. It has been approved to treat squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal carcinoma in different countries. Currently, the registered clinical trials of Nimotuzumab combined with chemotherapy in advanced non-small cell lung cancer, colorectal cancer, esophageal cancer and glioma have been approved and are ongoing all over the investigators' country. The main purpose of this study is to evaluate the pharmacokinetic characteristics of Nimotuzumab combined with Irinotecan in patients with solid tumors.
Read the detailed description
This is a single-centered, non-randomized and dose escalation trial of Nimotuzumab in patients with solid tumors. This trial was divided into two period. Period 1 is a single-dose PK study; Period 2 is a multiple-dose PK study.
In period 1: Participants were administered of nimotuzumab (four dose levels: 100 mg, 200mg, 400mg or 600mg), via intravenous catheter (IV), with 3 weeks observation.
In period 2: When period 1 completed, participants were administered 100 mg, 200mg, 400mg or 600mg of nimotuzumab weekly, combined with irinotecan (180mg/m^2) biweekly, for 6 weeks. The main purpose of this trial is to evaluate the pharmacokinetic characteristics of Nimotuzumab combined with Irinotecan in patients with solid tumors.
- Conditions
- Solid Tumors
- Being tested
- Nimotuzumab, Irinotecan
- Keywords
- Pharmacokinetics, Nimotuzumab, Safety, Effcacy, Irinotecan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimotuzumabDrug
Also called Taixinsheng
In period 1: Participants were administered single dose of nimotuzumab, via intravenous catheter (IV), with 3 weeks observation.
In period 2: Participants were administered nimotuzumab (four dose levels: 100mg, 200mg, 400mg, 600mg) weekly, for 6 weeks.
IrinotecanDrug
Also called CPT-11
In period 2: Participants were administered irinotecan (180mg/m^2) biweekly, for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Nimotuzumab 100 mg | Experimental | In period 1: Participants were administered 100 mg of nimotuzumab, via intravenous catheter (IV), with 3 weeks observation.
In period 2: Participants were administered 100 mg of nimotuzumab weekly, combined with irinotecan (180mg/m^2) biweekly, for 6 weeks. Receives: Drug: Nimotuzumab; Drug: Irinotecan |
| Nimotuzumab 200 mg | Experimental | In period 1: Participants were administered 200 mg of nimotuzumab, via intravenous catheter (IV), with 3 weeks observation.
In period 2: Participants were administered 200 mg of nimotuzumab weekly, combined with irinotecan (180mg/m^2) biweekly, for 6 weeks. Receives: Drug: Nimotuzumab; Drug: Irinotecan |
| Nimotuzumab 400 mg | Experimental | In period 1: Participants were administered 400 mg of nimotuzumab, via intravenous catheter (IV), with 3 weeks observation.
In period 2: Participants were administered 400 mg of nimotuzumab weekly, combined with irinotecan (180mg/m^2) biweekly, for 6 weeks. Receives: Drug: Nimotuzumab; Drug: Irinotecan |
| Nimotuzumab 600 mg | Experimental | In period 1: Participants were administered 600 mg of nimotuzumab, via intravenous catheter (IV), with 3 weeks observation.
In period 2: Participants were administered 600 mg of nimotuzumab weekly, combined with irinotecan (180mg/m^2) biweekly, for 6 weeks. Receives: Drug: Nimotuzumab; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of Nimotuzumab after administration of escalating single dosing and weekly fixed dosing in patients with solid tumors: Single dose：Tmax，Cmax， AUC，Vc，t1/2α，t1/2β，CL. Multiple dose：Tmax，Css-min，Css-max，Css-a，t1/2β，CL，AUCss，DF.
The measure is a composite.The measure of single dose：Tmax，Cmax， AUC，Vc，t1/2α，t1/2β，CL.
The measure of multiple dose：Tmax，Css-min，Css-max，Css-a，t1/2β，CL，AUCss，DF.
Measured: up to 9 weeks
Secondary outcomes (4)
Safety - AE measured by NCI CTCAE v 3.0
Safety evaluations included adverse events and changes in laboratory data.Adverse events were descriptive statistics, lists the event occurred, the duration, severity, and drug relationship, as well as its outcome.
Measured: Any adverse medical events occur from the beginning of receiving study drug to the end of treatment after 30 days
ORR（Objective Response Rate）
Efficacy as measured by RECIST v1.1
Measured: The third weekend and Ninth weekend
DCR（Disease Control Rate）
Efficacy as measured by RECIST v1.1
Measured: The third weekend and Ninth weekend
PFS（Progression Free Survival）
Efficacy as measured by RECIST v1.1
Measured: The third weekend and Ninth weekend
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startDec 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotech Pharmaceutical Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jinwan Wang, PhD，MD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395068
- Sponsor's protocol ID
- BT-PK-001
- Status last verified
- Feb 2025
- First submitted
- 28 Feb 2015
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics Study of Nimotuzumab Single-dose and Multiple-dose in Combination With Irinotecan in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT02395068
- Acronym / sponsor ID
- BT-PK-001
- Conditions
- Solid Tumors
- Keywords
- Pharmacokinetics, Nimotuzumab, Safety, Effcacy, Irinotecan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Biotech Pharmaceutical Co., Ltd.University, hospital or other
- Study start
- Dec 2012 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 Mar 2015 (estimated)
- 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.
Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR), inhibiting tyrosine kinase activation. It has been approved to treat squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal carcinoma in different countries. Currently, the registered clinical trials of Nimotuzumab combined with chemotherapy in advanced non-small cell lung cancer, colorectal cancer, esophageal cancer and glioma have been approved and are ongoing all over the investigators' country. The main purpose of this study is to evaluate the pharmacokinetic characteristics of Nimotuzumab combined with Irinotecan in patients with solid tumors.
Detailed description
This is a single-centered, non-randomized and dose escalation trial of Nimotuzumab in patients with solid tumors. This trial was divided into two period. Period 1 is a single-dose PK study; Period 2 is a multiple-dose PK study.
In period 1: Participants were administered of nimotuzumab (four dose levels: 100 mg, 200mg, 400mg or 600mg), via intravenous catheter (IV), with 3 weeks observation.
In period 2: When period 1 completed, participants were administered 100 mg, 200mg, 400mg or 600mg of nimotuzumab weekly, combined with irinotecan (180mg/m^2) biweekly, for 6 weeks. The main purpose of this trial is to evaluate the pharmacokinetic characteristics of Nimotuzumab combined with Irinotecan in patients with solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nimotuzumab 100 mg | Experimental | Drug: Nimotuzumab, Drug: IrinotecanIn period 1: Participants were administered 100 mg of nimotuzumab, via intravenous catheter (IV), with 3 weeks observation. In period 2: Participants were administered 100 mg of nimotuzumab weekly, combined with irinotecan (180mg/m^2) biweekly, for 6 weeks. |
| Nimotuzumab 200 mg | Experimental | Drug: Nimotuzumab, Drug: IrinotecanIn period 1: Participants were administered 200 mg of nimotuzumab, via intravenous catheter (IV), with 3 weeks observation. In period 2: Participants were administered 200 mg of nimotuzumab weekly, combined with irinotecan (180mg/m^2) biweekly, for 6 weeks. |
| Nimotuzumab 400 mg | Experimental | Drug: Nimotuzumab, Drug: IrinotecanIn period 1: Participants were administered 400 mg of nimotuzumab, via intravenous catheter (IV), with 3 weeks observation. In period 2: Participants were administered 400 mg of nimotuzumab weekly, combined with irinotecan (180mg/m^2) biweekly, for 6 weeks. |
| Nimotuzumab 600 mg | Experimental | Drug: Nimotuzumab, Drug: IrinotecanIn period 1: Participants were administered 600 mg of nimotuzumab, via intravenous catheter (IV), with 3 weeks observation. In period 2: Participants were administered 600 mg of nimotuzumab weekly, combined with irinotecan (180mg/m^2) biweekly, for 6 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Confirmed by pathology and / or cytology diagnosis in patients with advanced solid tumors
- Failure of first-line or multi-line chemotherapy and be suitable for irinotecan therapy
- Age 18-70 years, both genders at enrollment
- ECOG 0 to 1
- Adequate bone marrow function
Key exclusion criteria (16 listed)
- Have previously received EGFR-targeted therapy
- Current treatment on other effective programs
- Participated in other clinical trial within 4 weeks after enrollment
- Nervous system symptoms caused by brain metastases need to apply steroidal anti-edema medications to control
- Persistent uncontrollable diarrhea CTCAE 2 level and above (4-6 times daily)
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 |
|---|---|---|
| NimotuzumabAlso: TaixinshengIn period 1: Participants were administered single dose of nimotuzumab, via intravenous catheter (IV), with 3 weeks observation. In period 2: Participants were administered nimotuzumab (four dose levels: 100mg, 200mg, 400mg, 600mg) weekly, for 6 weeks. | Drug | Nimotuzumab 100 mg, Nimotuzumab 200 mg, Nimotuzumab 400 mg, Nimotuzumab 600 mg |
| IrinotecanAlso: CPT-11In period 2: Participants were administered irinotecan (180mg/m^2) biweekly, for 6 weeks. | Drug | Nimotuzumab 100 mg, Nimotuzumab 200 mg, Nimotuzumab 400 mg, Nimotuzumab 600 mg |
Primary outcome
Pharmacokinetics of Nimotuzumab after administration of escalating single dosing and weekly fixed dosing in patients with solid tumors: Single dose：Tmax，Cmax， AUC，Vc，t1/2α，t1/2β，CL. Multiple dose：Tmax，Css-min，Css-max，Css-a，t1/2β，CL，AUCss，DF.
Time frame: up to 9 weeks
The measure is a composite.The measure of single dose：Tmax，Cmax， AUC，Vc，t1/2α，t1/2β，CL. The measure of multiple dose：Tmax，Css-min，Css-max，Css-a，t1/2β，CL，AUCss，DF.
4 secondary outcomes
Safety - AE measured by NCI CTCAE v 3.0
Time frame: Any adverse medical events occur from the beginning of receiving study drug to the end of treatment after 30 days
ORR（Objective Response Rate）
Time frame: The third weekend and Ninth weekend
DCR（Disease Control Rate）
Time frame: The third weekend and Ninth weekend
PFS（Progression Free Survival）
Time frame: The third weekend and Ninth weekend
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 15 Oct 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.
Jinwan Wang, PhD，MD principal investigator
Cancer Institute and Hospital, Chinese Academy of 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 Nimotuzumab and Irinotecan in people with Solid Tumors, run by Biotech Pharmaceutical 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 10 inclusion and 16 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 15 Oct 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?
Pharmacokinetics of Nimotuzumab after administration of escalating single dosing and weekly fixed dosing in patients with solid tumors: Single dose：Tmax，Cmax， AUC，Vc，t1/2α，t1/2β，CL. Multiple dose：Tmax，Css-min，Css-max，Css-a，t1/2β，CL，AUCss，DF. (time frame: up to 9 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 15 Oct 2026.