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Metastatic Colorectal CancerPhase 2NCT03405272

Safety and Efficacy of Recombinant Anti-EGFR Monoclonal Antibody in Patients With Wild-type RAS and BRAF mCRC

A Phase 2 study testing Recombinant Anti-EGFR Monoclonal Antibody（SCT200） in people with Metastatic Colorectal Cancer, run by Sinocelltech Ltd. at 21 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of recombinant anti-EGFR Monoclonal antibody（SCT200）in patients with wild-type RAS and BRAF mCRC treated with fluorouracil, oxaliplatin and irinotecan after failure of standard therapy Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Recombinant Anti-EGFR Monoclonal Antibody（SCT200）
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
21 sitesChina
Study dates
12 Feb 2018to 1 Dec 2019
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to provide written informed consent and can understand and comply with the requirements of the study;
  • Men and women ≥ 18 years of age;
  • Life expectancy of longer than 3 months ( clinical assessment);
  • With an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1;
  • Have been diagnosed as mCRC verified histologically;
  • Patients treated with fluorouracil, oxaliplatin and irinotecan after failure of standard therapy. Disease progressed or developed non-tolerable toxicity after systemic chemotherapy：a. at least one treatment cycle should be completed, and maintenance therapy using one of the doublets is considered as the same line of therapy ; b. May have received adjuvant therapy for primary colorectal cancer provided that at least 6 months have elapsed from the time the adjuvant therapy was concluded and recurrent disease was documented;
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  • RAS and BRAF wildtype status of primary colorectal cancer or related metastasis;
  • Adequate organ and marrow function as defined below:
  • Absolute neutrophil count (ANC) greater than/equal to 1.5×l09/L; Platelets greater than/equal to 75×109/L; Hemoglobin greater than/equal to 80g/L; Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than/equal to 2.5 times IULN, or less than/equal to 5 times IULN if known liver metastases; Total bilirubin less than/equal to 1.5 within institutional upper limit of normal (IULN); Serum creatinine less than/equal to 1.5 times IULN; Electrolyte: magnesium greater than/equal to normal.
  • According to RECIST 1.1 , patients must have at least one measurable lesion that can be accurately assessed at baseline and is suitable for repeated assessment by CT, MRI. Longest diameter greater than/equal to10mm（CT scan slice thickness no greater than 5 mm）, a lymph node must be ≥15mm in short axis when assessed by CT scan.

Who cannot join

  • Patient with active brain metastasis or indicated for symptomatic treatment for brain metastasis, untreated with proper radiation therapy, showing clinical symptoms or symptom stable time less than 28 days;
  • Patients with other primary malignancies within the past 5 years except non-melanoma skin cancer, carcinoma in situ of cervix or prostatic intraepithelial neoplasia;
  • Patients who are allergic to analogue of SCT200 and/or its inactive ingredients;
  • Patients administrated EGFR target treatment including EGFR TKI agent or anti- EGFR monoclonal antibody;
  • Within 4 weeks, patients received anti-tumor drugs (such as chemotherapy, hormone therapy, immune therapy, the antibody therapy, radiotherapy) or research drugs, or patients with grade 2 or more adverse reaction caused by previous anti-tumor therapy(except alopecia or neurotoxicity grade 2 or less);
  • Patients are currently enrolled in other research devices or in research drugs, or less than 4 weeks from other research drugs or devices.
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  • Patients received major surgery(such as need general anesthesia ) within 4 weeks , should recover from the injury associated with the surgery.
  • Patients treated with EPO, G-CSF or GM-CSF.
  • Patients who have clinically significant cardiovascular disease (defined as unstable angina pectoris, symptomatic congestive heart failure (NYHA, greater than II), uncontrollable severe arrhythmia);
  • Patients occurred myocardial infarction within 6 months.
  • Patients who have interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or CT or MRI reminder ILD .
  • Patients with clinical symptoms, required clinical intervention or stable time less than 4 weeks of serous cavity effusion (such as pleural effusion and ascites);
  • Patients with serious psychological or psychiatric disorders which may affect subject compliance in this clinical study;
  • Pregnant or lactating women, or women who planned to be pregnant within 6 months of treatment;
  • Patients who were not willing to accept effective contraceptive measures (including male or female subjects) during treatment and within 6 months after treatment;
  • Patients with active hepatitis B or active hepatitis C, etc. (for patients with a history of hepatitis B, whether treated or not, HBV DNA ≥104 or ≥ 2000IU/ml, HCV RNA≥15IU/ml); HIV antibody positive (if there is no clinical evidence suggesting that there may be HIV infection, there is no need to detect);
  • Patients with uncontrolled active infections before enrollment 2 weeks (except simple urinary tract infection or upper respiratory tract infection);
  • Patients have alcohol or drug addiction;
  • Inability to comply with study and/or follow-up procedures

Trial locations and contacts

21 sites in 1 country.

xiaoling yang contact

0086-10-58628288 ext. 9492

xiaoling_yang@sinocelltech.com

21 sites in 1 country

China21 sites

  • Cancer hospital Chinese academy of medical sciences

    Beijing, Beijing Municipality

    yuankai shi, MD

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality

    guanghai dai, MD

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

    jianfeng zhou, MD

  • Jilin Cancer Hospital

    Changchun, Jilin

    ying cheng, MD

  • The First Hospital of Jilin University

    Changchun, Jilin

    wei li, MD

  • Hunan Cancer Hospital

    Changsha, Hunan

    xianli yin, MD

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan

    peiguo cao, MD

  • West China Hospital, Sichuan University

    Chengdu, Sichuan

    yali shen, MD

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning

    yajie gao, MD

  • Fujian Cancer Hospital

    Fuzhou, Fujian

    yigui chen, MD

  • The Sixth Affiliated Hospital Of Sun Yat-sen University

    Guangzhou, Guangdong

    yanhong deng, MD

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

    jie'er ying, MD

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

    yuxian bai, MD

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

    kangsheng gu, MD

  • Lin Yi Cancer Hospital

    Linyi, Shandong

    jianhua shi, MD

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

    lingjun zhu, MD

  • Zhongshan hospital

    Shanghai, Shanghai Municipality

    tianshu liu, MD

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality

    yi ba, MD

  • The First Affiliated Hospital Of Xinjiang Medical University

    Ürümqi, Xinjiang

    mayinuer aili, MD

  • Xiking Hospital

    Xi'an, Shaanxi

    yongzhan nie, MD

  • Henan Cancer Hospital.

    Zhengzhou, Henan

    suxia luo, MD

Other trials in China

About this study

Official title: Recombinant Anti-EGFR Monoclonal Antibody（SCT200） in Patients With Chemotherapy- Refractory Wild Type RAS and BRAF Metastatic Colorectal Cancer

The purpose of this study is to evaluate the efficacy and safety of recombinant anti-EGFR Monoclonal antibody（SCT200）in patients with wild-type RAS and BRAF mCRC treated with fluorouracil, oxaliplatin and irinotecan after failure of standard therapy

Being tested
Recombinant Anti-EGFR Monoclonal Antibody（SCT200）
Keywords
Full human anti-EGFR monoclonal antibody (SCT200), metastatic colorectal cancer （mCRC）
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 Anti-EGFR Monoclonal Antibody（SCT200）Biological

    Experimental: recombinant anti-EGFR monoclonal antibody（SCT200） Recombinant Anti-EGFR Monoclonal Antibody（SCT200）. Initially, SCT200 6.0mg/kg will be administered at day 1 every week for a maximum of 6 cycles. After 6 cycles SCT200 8.0mg/kg will be administered at day 2 every weeks until disease progression.

Study groups in NCT03405272
Study groupRoleWhat they receive
recombinant anti-EGFR monoclonal antibody（SCT200）ExperimentalInitially, 6.0mg/kg of SCT200 will be administered once a week for a maximum of 6 cycles. After 6 cycles, 8.0mg/kg of SCT200 will be administered every two weeks until disease progression.
Receives: Biological: Recombinant Anti-EGFR Monoclonal Antibody（SCT200）

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate

    The achievement of either a partial response (PR) or complete response (CR), according to RECIST 1.1 criteria

    Measured: 1 year

Secondary outcomes (7)

  1. Objective response rate - left side

    The achievement of either a partial response (PR) or complete response (CR), left side mCRC patients treated by SCT200. according to RECIST 1.1 criteria

    Measured: 1 year

  2. Best of response

    Number of patients in each response category（CR, PR, SD, PD）, according to RECIST 1.1 criteria

    Measured: 1 year

  3. Duration of response

    Defined as the time from the date that the response criteria are first met to the date that progressive disease (PD) is objectively documented or death, whichever occurs first.

    Measured: 1 year

  4. Disease control rate

    The achievement of any a stableresponse（SD）, partial response (PR) or complete response (CR), according to RECIST 1.1 criteria

    Measured: 1 year

  5. Time to response

    Defined as the time from first dose of SCT200 to documentation of a response.according to RECIST 1.1 criteria

    Measured: 1 year

  6. Progression free survival

    Defined as time from first dose of SCT200 until first documentation of Progression or death, whichever comes first， according to RECIST 1.1 criteria

    Measured: 1 year

  7. Overall survival

    Defined as the time from first dose of SCT200 until death.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2018
  2. Study start12 Feb 2018 (estimated)
  3. Primary completion1 Dec 2018 (estimated)
  4. Study completion1 Dec 2019 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Model description
Treated with recombinant anti-EGFR Monoclonal antibody（SCT200）until disease progression
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03405272
Sponsor's protocol ID
SCT200mCRCⅡ
Status last verified
Jan 2018
First submitted
11 Jan 2018
Last updated
23 Jan 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Recombinant Anti-EGFR Monoclonal Antibody（SCT200） in people with Metastatic Colorectal Cancer, run by Sinocelltech Ltd. at 21 sites 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 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 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites 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 xiaoling yang (0086-10-58628288 ext. 9492, xiaoling_yang@sinocelltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: 1 year). 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 NCT03405272.

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 Jan 2018.

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