Metastatic Colorectal CancerPhase 1NCT02211443
Safety, Tolerability and Pharmacokinetics of Recombinant Anti-epidermal Growth Factor Receptor(EGFR) Monoclonal Antibody in Patients With Metastatic Colorectal Cancer
A Phase 1 study testing Recombinant full human Anti-EGFR Monoclonal Antibody in people with Metastatic Colorectal Cancer, run by Sinocelltech Ltd..
Trial summary
The purpose of this study is to determine whether SCT200 is safe and tolerant in the treatment of 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?
- Recombinant full human Anti-EGFR Monoclonal Antibody
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2015
- 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
- aged from 18 to 70 years;
- having histologically confirmed metastatic colorectal cancer;
- having experienced previous treatment failures including fluoropyrimidine, irinotecan and oxaliplatine chemotherapy regiment;
- having determined wild-type KRAS tumor;
- having to have measurable or nonmeasurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; and expected survival of at least ≥3 months;
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- adequate hematological, renal and liver functions:
- Hematological function: white blood cell count of >4.0×109/L; absolute neutrophil count of >1.5×109/ L; platelet count of >100×109/L; hemoglobin level of >90.0 g/L;
- Renal function: serum creatinine level of<1.5×upper limit of normal (ULN);
- Liver function: total bilirubin level of<1.5×ULN; aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of <1.5×ULN; or <5 × ULN for patients with liver metastases;
- no other malignancies only if they had following malignancies , which were not required to treat or who had curative resection: cervical carcinoma in situ, the skin basal carcinoma or squamous cell carcinoma, bladder epithelial tumors, or only they had some malignancies requirement only surgical therapy and disease free survival≥5 years;
- no serious nonmalignant diseases including hypertension, diabetes mellitus, coronary artery disease, and mental disorder.
- not pregnant; or not lactating; or accepted birth control methods during the study;
- signed an informed consent form which was approved by the institutional review board of the respective medical center .
Who cannot join
- had received EGFR target treatment including EGFR tyrosine kinase inhibitors(TKI), or anti- EGFR monoclonal antibody;
- having to be at least 4 weeks beyond prior anticancer therapy (including corticosteroid , or nitrosourea or mitomycin within 6 weeks of study entry) or participating in other clinical trial, or have not recovered from significant toxicities of prior therapy;
- chronic use of medication that could interfere with the assessment of drug-related toxicities or immunologic activity (high dose prednisone or high dose non-steroid anti-inflammatory medication);
- had recent major surgery (within 28 days);
- with symptomatically brain metastases (with the exception of clinically brain metastases stable and of no requirement further treatment);
- with active infection requirement systemic antibiotics treatment; or serious cardiovascular disease;or with evidence of active hepatitis B or C infection; or with human immunodeficiency virus infection;
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- had acute pulmonary disorder; or interstitial pneumonia; or symptomatically chronic obstructive pulmonary disease (COPD) or with risk factors to COPD;
- with eye inflammation or infection, or any risk factors who could lead to eye disease;
- with a history of allergic reaction or protein product allergy including antibodies product;
- pregnant, or lactating, or not accepted birth control methods including male patients.
- had a history of alcohol or drugs addiction, or with any risk which may affect the patient's health evaluation or mantle state
About this study
Official title: A Phase I Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of SCT200, a Recombinant Full Human Anti-epidermal Growth Factor Receptor(EGFR) Monoclonal Antibody，in Patients With Metastatic Colorectal Cancer Following Fluoropyrimidine, Irinotecan and Oxaliplatine Chemotherapy Regiment
The purpose of this study is to determine whether SCT200 is safe and tolerant in the treatment of metastatic colorectal cancer
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Recombinant full human Anti-EGFR Monoclonal Antibody
- Keywords
- Full human anti-EGFR monoclonal antibody (SCT200) ;, metastatic colorectal cancer （mCRC）;, Escalating doses ;, single dose and multiple doses;, safety, tolerability and pharmacokinetics.
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant full human Anti-EGFR Monoclonal AntibodyBiological
Also called SCT200
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Two phase study of Recombinant full human Anti-epidermal growth factor receptor(EGFR) Monoclonal Antibody:
First phase: seven escalating single-dose groups : 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0 mg/kg
Second phase: multiple-dose groups 0.5, 1.0, 2.0, 3.0 mg/kg: weekly once for 4 doses; 5.0, 6.0 mg/kg: every two weeks for 2 doses; 4.0 mg/kg: weekly or every two weeks depends on the results of previous dose groups. Receives: Biological: Recombinant full human Anti-EGFR Monoclonal Antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with SCT200-related adverse events
Measured: up to 105 days
Secondary outcomes (1)
Area Under the plasma concentration versus time curve (AUC) of SCT200
Measured: prior to the initial dose and 0,0.5,1,2,4,8,24,48 hours,4,7,14,21days post- first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sinocelltech 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211443
- Sponsor's protocol ID
- SCT200mCRCI
- Status last verified
- Apr 2015
- First submitted
- 5 Aug 2014
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhang W, Han X, Yang L, Song Y, Xie L, Gai W, Wang Y, Shi Y. Safety, pharmacokinetics and efficacy of SCT200, an anti-EGFR monoclonal antibody in patients with wild-type KRAS/NRAS/BRAF metastatic colorectal cancer: a phase I dose-escalation and dose-expansion study. BMC Cancer. 2022 Oct 28;22(1):1104. doi: 10.1186/s12885-022-10147-9.
PubMed 36307775
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of SCT200, a Recombinant Full Human Anti-epidermal Growth Factor Receptor(EGFR) Monoclonal Antibody，in Patients With Metastatic Colorectal Cancer Following Fluoropyrimidine, Irinotecan and Oxaliplatine Chemotherapy Regiment
- ClinicalTrials.gov ID
- NCT02211443
- Acronym / sponsor ID
- SCT200mCRCI
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Full human anti-EGFR monoclonal antibody (SCT200) ;, metastatic colorectal cancer （mCRC）;, Escalating doses ;, single dose and multiple doses;, safety, tolerability and pharmacokinetics.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 7 Aug 2014 (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.
The purpose of this study is to determine whether SCT200 is safe and tolerant in the treatment of metastatic colorectal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Biological: Recombinant full human Anti-EGFR Monoclonal AntibodyTwo phase study of Recombinant full human Anti-epidermal growth factor receptor(EGFR) Monoclonal Antibody: First phase: seven escalating single-dose groups : 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0 mg/kg Second phase: multiple-dose groups 0.5, 1.0, 2.0, 3.0 mg/kg: weekly once for 4 doses; 5.0, 6.0 mg/kg: every two weeks for 2 doses; 4.0 mg/kg: weekly or every two weeks depends on the results of previous dose groups. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- aged from 18 to 70 years;
- having histologically confirmed metastatic colorectal cancer;
- having experienced previous treatment failures including fluoropyrimidine, irinotecan and oxaliplatine chemotherapy regiment;
- having determined wild-type KRAS tumor;
- having to have measurable or nonmeasurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1;
Key exclusion criteria (11 listed)
- had received EGFR target treatment including EGFR tyrosine kinase inhibitors(TKI), or anti- EGFR monoclonal antibody;
- having to be at least 4 weeks beyond prior anticancer therapy (including corticosteroid , or nitrosourea or mitomycin within 6 weeks of study entry) or participating in other clinical trial, or have not recovered from significant toxicities of prior therapy;
- chronic use of medication that could interfere with the assessment of drug-related toxicities or immunologic activity (high dose prednisone or high dose non-steroid anti-inflammatory medication);
- had recent major surgery (within 28 days);
- with symptomatically brain metastases (with the exception of clinically brain metastases stable and of no requirement further treatment);
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 |
|---|---|---|
| Recombinant full human Anti-EGFR Monoclonal AntibodyAlso: SCT200 | Biological | Single arm |
Primary outcome
Number of participants with SCT200-related adverse events
Time frame: up to 105 days
1 secondary outcome
Area Under the plasma concentration versus time curve (AUC) of SCT200
Time frame: prior to the initial dose and 0,0.5,1,2,4,8,24,48 hours,4,7,14,21days post- first dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
- Derived from this study: PubMed 36307775Zhang W, Han X, Yang L, Song Y, Xie L, Gai W, Wang Y, Shi Y. Safety, pharmacokinetics and efficacy of SCT200, an anti-EGFR monoclonal antibody in patients with wild-type KRAS/NRAS/BRAF metastatic colorectal cancer: a phase I dose-escalation and dose-expansion study. BMC Cancer. 2022 Oct 28;22(1):1104. doi: 10.1186/s12885-022-10147-9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant full human Anti-EGFR Monoclonal Antibody in people with Metastatic Colorectal Cancer, run by Sinocelltech Ltd..
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 14 inclusion and 11 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 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Number of participants with SCT200-related adverse events (time frame: up to 105 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02211443, which also lists 1 linked publication.
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 9 Apr 2015.