Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Initially, 9.0mg/kg of SCT200 will be administered once a week for a maximum of 6 cycles. After 6 cycles, 12.0mg/kg of SCT200 will be administered every two weeks until disease progression.

Initially,12.0mg/kg of SCT200 will be administered once a week for a maximum of 6 cycles. After 6 cycles, 15.0mg/kg of SCT200 will be administered every two weeks until disease progression.

Recombinant Anti-EGFR Monoclonal Antibody

SCT200

CHENG YING, MD

The purpose of this study is to evaluate the efficacy and safety of recombinant anti-EGFR monoclonal antibody（SCT200）in patients with advanced squamous non-small cell lung cancer treated after failure of Two chemotherapy regimens (including Platinum-based drugs).

This open label multicenter phase Ib study is designed to evaluate Objective Response Rate (ORR) in Squamous non-small cell Lung cancer treated with anti-EGFR monoclonal antibody SCT200.

Efficacy and Safety of SCT200 in Patients With Advanced Squamous Non-small Cell Lung Cancer

Recombinant Anti-EGFR Monoclonal Antibody（SCT200） in Patients With Advanced Squamous Non-small Cell Lung Cancer : a Phase Ib, Open-label, Multicenter Study

ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 during trial treatment.

PFS is defined as the time from first dose of SCT200 until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 criteria.

The achievement of any a stable response（SD）, partial response (PR) or complete response (CR), according to RECIST v1.1 criteria.

DOR is defined as time from the date when a patient first meets the criteria for CR or PR according to RECIST v1.1, until the date that progressive disease (PD) is objectively documented or death, whichever occurs first.

OS is defined as time from first dose of SCT200 until the date of death from any cause.

AE are assessed according to NCI CTCAE v4.03.

Serum SCT200 antibody levels were measured before and after administration.

To explore the possible correlation between EGFR and/or related gene expression and disease prognosis and therapeutic efficacy

Sinocelltech Ltd.

Symptoms and General Pathology

Recurrence

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Antineoplastic Agents

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Immune Checkpoint Inhibitors

Tubulin Modulators

Antimitotic Agents

SCT200+SCT-I10A was given to patients who had failed previous platinum-based therapy. Among them, SCT200 was administered as 6 mg/kg/QW for 12 weeks and 8 mg/kg/Q2W maintenance by intravenous infusion; SCT-I10A was 200 mg/Q3W by intravenous infusion for no more than 2 years. Every 6 weeks is a treatment cycle. After the first dose, tumor assessment was performed every 6 weeks until the occurrence of PD, initiation of new antitumor therapy, withdrawal of informed consent, death, or loss of visit

SCT200+SCT-I10A was given to patients who had failed previous platinum-based and immune checkpoint inhibitor therapy. Among them, SCT200 was administered as 6 mg/kg/QW for 12 weeks and 8 mg/kg/Q2W maintenance by intravenous infusion; SCT-I10A was 200 mg/Q3W by intravenous infusion for no more than 2 years. Every 6 weeks is a treatment cycle. After the first dose, tumor assessment was performed every 6 weeks until the occurrence of PD, initiation of new antitumor therapy, withdrawal of informed

SCT200+paclitaxel/docetaxel was given to patients who had failed previous platinum-based and immune checkpoint inhibitor therapy. Among them, SCT200 was administered as 6 mg/kg/QW for 12 weeks and 8 mg/kg/Q2W maintenance by intravenous infusion; paclitaxel was 80mg/m\^2/QW by intravenous infusion; docetaxel was 75mg/m\^2/Q3W. Every 6 weeks is a treatment cycle. After the first dose, tumor assessment was performed every 6 weeks until the occurrence of PD, initiation of new antitumor therapy, withdrawal of informed

SCT200+SCT-I10A was given to patients who have not received prior systemic chemotherapy. Among them, SCT200 was administered as 6 mg/kg/QW for 12 weeks and 8 mg/kg/Q2W maintenance by intravenous infusion; SCT-I10A was 200 mg/Q3W by intravenous infusion for no more than 2 years. Every 6 weeks is a treatment cycle. After the first dose, tumor assessment was performed every 6 weeks until the occurrence of PD, initiation of new antitumor therapy, withdrawal of informed

SCT-I10A

paclitaxel

docetaxel

Fuqiang Chen

Chaodan Tan

Ye Guo, Ph.D

The study is to explore the efficacy and safety of SCT200 with SCT-I10A or SCT200 combined with paclitaxel/docetaxel in the treatment of recurrent/metastatic head and neck squamous cell carcinoma.

This multicenter, open phase Ib study focused on evaluating the objective response response rates of SCT200 in combination with SCT-I10A or SCT200 in combination with paclitaxel/docetaxel in patients with recurrent/metastatic head and neck squamous cell carcinoma who had previously received different treatments.

SCT200 in Combination With SCT-I10A/Paclitaxel/Docetaxel in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

A Multicenter, Open Phase Ib Study to Evaluate the Efficacy and Safety of SCT-I10A in Combination With SCT200 or SCT200 in Combination With Paclitaxel/Docetaxel in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Related adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) V5.0. An adverse event (AE) is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product.

Serum anti-SCT200 antibody and anti-SCT-I10A antibody levels before and after administration

ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) confirmed by the overall best response rate (assessed according to RECIST version 1.1).

DCR is defined as the proportion of subjects who achieve best overall response of complete response (CR), partial response (PR) or stable disease (SD) according to RECIST version 1.1

DOR is defined as the time from first response to first disease progression or death

PFS is defined as the time between the date of first dose and the date of first documented disease progression (as assessed by RECIST version 1.1) or death from any cause.

OS is defined as the time from the date of first drug administration to death from any cause.

For cohort1、2-1 and 3, evaluating correlation of PD-L1 expression level with efficacy and prognosis

Digestive System Diseases

Rare Diseases

Esophageal Squamous Cell Carcinoma

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Esophageal Neoplasms

Esophageal Diseases

Esophageal Cancer

Oxaliplatin

Capecitabine

SCT-I10A: 200 mg intravenous (IV) on Day 1 of Q3W. SCT200: 6mg/kg intravenous (IV) on Day 1 of QW, then 8mg/kg intravenous (IV) on Day 1 of Q2W

SCT-I10A: 200 mg intravenous (IV) on Day 1 of Q3W. SCT200: 6mg/kg intravenous (IV) on Day 1 of QW, then 8mg/kg intravenous (IV) on Day 1 of Q2W.

Chemotherapy: Capecitabine and Oxaliplatin.

6mg/kg intravenous (IV) on Day 1 of QW, then 8mg/kg intravenous (IV) on Day 1 of Q2W

Chemotherapy

Foxiao Qiao, Ph D

Yi Ba, MD

The purpose of this study is to evaluate the safety and efficacy of SCT-I10A combined SCT200 or SCT-I10A combined SCT200 plus chemotherapy in advanced esophageal squamous cell carcinoma and colorectal cancer

This is a open label, multicenter, phase III study designed to evaluate the safety and efficacy in advanced esophageal squamous cell carcinoma and colorectal cancer treated with SCT-I10A combined SCT200 or SCT-I10A combined SCT200 plus chemotherapy.

Study of SCT-I10A Combined SCT200 or SCT-I10A Combined SCT200 Plus Chemotherapy in ESCC and CRC

To Evaluate Safety and Efficacy of SCT-I10A Combined SCT200 or SCT-I10A Combined SCT200 Plus Chemotherapy in Advanced Esophageal Squamous Cell Carcinoma and Colorectal Cancer: a Phase Ⅰb, Open-label, Multicenter Study

Including adverse events and safety of laboratory tests

ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 or Lugano 2014 criteria during trial treatment

DOR is defined as time from the date when a patient first meets the criteria for CR or PR according to RECIST v1.1 or Lugano 2014 criteria, until the date that progressive disease (PD) is objectively documented or death, whichever occurs first

The achievement of any a stable response（SD）, partial response (PR) or complete response (CR), according to RECIST v1.1 or Lugano 2014 criteria

PFS is defined as the time from first dose of SCT200 until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 or Lugano 2014 criteria

OS is defined as time from first dose of SCT200 until the date of death from any cause

Fluorouracil

Mitogens

Anti-EGFR monoclonal antibody DDP(75mg/m2),d1; 5-FU(750mg/m2),d1-5, every 21d; PF chemothrapy up to 6 cycles. 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.

Anti-EGFR monoclonal antibody DDP(75mg/m2),d1; 5-FU(750mg/m2),d1-5, every 21d; PF chemothrapy up to 6 cycles. 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

Other Names:

• SCT200

Yuankai Shi, MD

The purpose of this study is to evaluate the efficacy and safety of first-line with recombinant anti-EGFR monoclonal antibody#SCT200#and standard chemotherapy in patients with Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma.

This open label, single-arm and multicenter phase II study is designed to evaluate Objective Response Rate (ORR) of first-line with anti-EGFR monoclonal antibody#SCT200#and standard chemotherapy in Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma.

SCT200 Plus Platinum-based Chemotherapy in Head and Neck Squamous Cell Carcinoma

A Phase II Study of Evaluating Recombinant Human Anti-EGFR Monoclonal Antibody (SCT200) and Standard Chemotherapy for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma

The achievement of any stable disease#SD#, partial response (PR) or complete response (CR), according to RECIST v1.1 criteria.

Serum anti-SCT200 antibody levels before and after administration

Median scores for each item and domain will be reported at each time point. 30 items questionnaire with answers ranging from 1=not at all to 4=very much includes five functional scales (physical, role, emotional, cognitive and social), three symptom scales (fatigue, nausea \& vomiting and pain) and a global health status/QOL scale.

Furthermore, it contains six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties)

European organization for research and treatment of cancer quality of life questionnaire head and neck 35(EORTC QLQ-H \& N 35) is a specific questionnaire developed by the European Organisation for Research and Treatment of Cancer for head and neck cancer. The module includes 35 questions Assessing symptoms and side effects of treatment, social function and body image/sexuality .This scale includes seven symptoms subscales that measure pain, swallowing, senses problems, speech problems, trouble with social eating, trouble with social Contact, and less sexuality, and also has 11 subscales related with teeth, opening mouth, dry mouth, sticky saliva, coughing, ill feeling, weight loss, weight gain, use of painkillers, nutritional supplements, and feeding tubes. Standardize the original scores, with scores ranging from 0 to 100, with higher scores representing more serious problems.

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Lymphosarcoma

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

Recombinant Anti-EGFR Monoclonal Antibody （SCT200）

jianming xu, MD

The purpose of this study is to evaluate the efficacy and safety of recombinant anti-EGFR monoclonal antibody（SCT200）in patients with advanced solid tumors treated after failure of standard therapy.

This open label, multicenter phase Ib study is designed to evaluate Objective Response Rate (ORR) in advanced solid tumors (gastric/gastroesophageal junction cancer, hepatocellular carcinoma,pancreatic cancer,gallbladder cancer/bile duct cancer，renal cell carcinoma，ovarian cancer，or other advanced solid tumor) treated with anti-EGFR monoclonal antibody SCT200.

Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCT200 in Patients With Advanced Solid Tumors

Recombinant Anti-EGFR Monoclonal Antibody（SCT200）in Patients With Advanced Solid Tumors or Lymphoma : A Phase Ⅰb, Open-label, Multicenter Study.

Taxane

Immunologic Factors

6.0mg/kg QW for 6 weeks, then 8.0mg/kg Q2W

Experimental: 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.

recombinant anti-EGFR monoclonal antibody

yuxian bai, MD

kai zang, MD

wei li, MD

yi ba, MD

The purpose of this study is to evaluate the efficacy and safety of recombinant anti-EGFR monoclonal antibody（SCT200）in patients with advanced esophageal squamous cell carcinoma progressed following treatment with taxane/platinum/fluorouracil.

This is a open label, single-arm multicenter phase Ib study,and is designed to evaluate Objective Response Rate (ORR) in advanced esophageal squamous cell carcinoma progressed following treatment with taxane/platinum/fluorouracil treated with anti-EGFR monoclonal antibody SCT200.

Safety and Efficacy of SCT200 in Patients With Advanced Esophageal Squamous Cell Carcinoma

Phase Ib, Open-label, Single-arm, Multicenter Study to Evaluate Safety and Efficacy of SCT200 in Patients With Advanced Esophageal Squamous Cell Carcinoma Progressed Following Treatment With Taxane/Platinum/Fluorouracil

DOR is defined as time from the date when a patient first meets the criteria for CR or PR according to RECIST v1.1, until the date that progressive disease (PD) is objectively documented or death, whichever occurs first

Tianjin Medical University Cancer Institute and Hospital

Skin and Connective Tissue Diseases

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Initially, 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.

Recombinant Anti-EGFR Monoclonal Antibody（SCT200）

qingyuan zhang, MD

The purpose of this study is to evaluate the efficacy and safety of recombinant anti-EGFR monoclonal antibody（SCT200）in patients with triple receptor negative breast cancer treated after failure of standard therapy (including Anthracyclines and/or Taxanes).

This open label,single-arm multicenter phase II study is designed to evaluate Objective Response Rate (ORR) in advanced triple receptor negative breast cancer treated with anti-EGFR monoclonal antibody SCT200.

Safety and Efficacy of SCT200 in Patients With Relapsed or Metastatic Triple Receptor Negative Breast Cancer

Recombinant Anti-EGFR Monoclonal Antibody（SCT200） in Patients With Relapsed or Metastatic Triple Receptor Negative Breast Cancer : a Phase Ⅱ, Open-label, Single-arm, Multicenter Study

TTP is defined as the time from first dose of SCT200 until the date of first documentation of progressive disease (PD), according to RECIST v1.1 criteria.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety of SCT200 in Patients With Advanced Squamous Non-small Cell Lung Cancer	NCT03808701	Advanced Squamo...	SCT200	18 Years - 75 Years	Sinocelltech Ltd.
SCT200 in Combination With SCT-I10A/Paclitaxel/Docetaxel in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma	NCT05552807	Head and Neck S...	SCT-I10A SCT200 paclitaxel docetaxel	18 Years -	Sinocelltech Ltd.
Study of SCT-I10A Combined SCT200 or SCT-I10A Combined SCT200 Plus Chemotherapy in ESCC and CRC	NCT04229537	Esophageal Squa... Colorectal Canc...	SCT-I10A SCT200 Chemotherapy	18 Years - 75 Years	Sinocelltech Ltd.
Efficacy and Safety of SCT200 in Patients With Advanced Squamous Non-small Cell Lung Cancer	NCT03808701	Advanced Squamo...	SCT200	18 Years - 75 Years	Sinocelltech Ltd.
SCT200 Plus Platinum-based Chemotherapy in Head and Neck Squamous Cell Carcinoma	NCT03874741	Head and Neck S...	SCT200	18 Years - 75 Years	Sinocelltech Ltd.
Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCT200 in Patients With Advanced Solid Tumors	NCT03692520	Advanced Solid ...	SCT200	18 Years - 75 Years	Sinocelltech Ltd.
Safety and Efficacy of SCT200 in Patients With Advanced Esophageal Squamous Cell Carcinoma	NCT03817567	Esophageal Squa...	recombinant ant...	18 Years - 75 Years	Sinocelltech Ltd.
Safety and Efficacy of SCT200 in Patients With Relapsed or Metastatic Triple Receptor Negative Breast Cancer	NCT03692689	Triple Negative...	SCT200	18 Years - 75 Years	Sinocelltech Ltd.
Safety and Efficacy of SCT200 in Patients With Relapsed or Metastatic Triple Receptor Negative Breast Cancer	NCT03692689	Triple Negative...	SCT200	18 Years - 75 Years	Sinocelltech Ltd.
Safety and Efficacy of SCT200 in Patients With Advanced Esophageal Squamous Cell Carcinoma	NCT03817567	Esophageal Squa...	recombinant ant...	18 Years - 75 Years	Sinocelltech Ltd.
Safety and Efficacy of SCT200 in Patients With Advanced Esophageal Squamous Cell Carcinoma	NCT03817567	Esophageal Squa...	recombinant ant...	18 Years - 75 Years	Sinocelltech Ltd.
Efficacy and Safety of SCT200 in Patients With Advanced Squamous Non-small Cell Lung Cancer	NCT03808701	Advanced Squamo...	SCT200	18 Years - 75 Years	Sinocelltech Ltd.

Spots Global Cancer Trial Database for sct200

Every month we try and update this database with for sct200 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sct200

Every month we try and update this database with for sct200 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sct200 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.