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Report for Clinical Trial NCT04229537

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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

NCT04229537 Esophageal Squamous Cell Carcinoma Colorectal Cancer
MeSH:Carcinoma Colorectal Neoplasms Carcinoma, Squamous Cell Esophageal Squamous Cell Carcinoma
HPO:Carcinoma Neoplasm of the large intestine Squamous cell carcinoma

3 Interventions

Name: SCT-I10A

Description: 200 mg intravenous (IV) on Day 1 of Q3W.
Type: Biological
Group Labels: 4

SCT-I10A combined SCT200 in CRC SCT-I10A combined SCT200 in ESCC SCT-I10A combined SCT200 plus Ch SCT-I10A combined SCT200 plus Chemotherapy in CRC

Name: SCT200

Description: 6mg/kg intravenous (IV) on Day 1 of QW, then 8mg/kg intravenous (IV) on Day 1 of Q2W
Type: Biological
Group Labels: 3

SCT-I10A combined SCT200 in CRC SCT-I10A combined SCT200 in ESCC SCT-I10A combined SCT200 plus Chemotherapy in CRC

Name: Chemotherapy

Description: Capecitabine and Oxaliplatin.
Type: Other
Group Labels: 1

SCT-I10A combined SCT200 plus Chemotherapy in CRC


Primary Outcomes

Description: Including adverse events and safety of laboratory tests

Measure: Rate of adverse events

Time: 24 months

Secondary Outcomes

Description: 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

Measure: Objective response rate (ORR)

Time: 24 months

Description: 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

Measure: Duration of response (DOR)

Time: 24 months

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

Measure: Disease control rate (DCR)

Time: 24 months

Description: 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

Measure: Progression free survival (PFS)

Time: 24 months

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

Measure: Overall survival (OS)

Time: 24 months

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There is one SNP

SNPs


1 I10A

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. --- I10A ---

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. --- I10A --- --- I10A ---

Study of SCT-I10A Combined SCT200 or SCT-I10A Combined SCT200 Plus Chemotherapy in ESCC and CRC 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 Rate of adverse events. --- I10A ---

Study of SCT-I10A Combined SCT200 or SCT-I10A Combined SCT200 Plus Chemotherapy in ESCC and CRC 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 Rate of adverse events. --- I10A --- --- I10A ---

Study of SCT-I10A Combined SCT200 or SCT-I10A Combined SCT200 Plus Chemotherapy in ESCC and CRC 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 Rate of adverse events. --- I10A --- --- I10A --- --- I10A ---

Study of SCT-I10A Combined SCT200 or SCT-I10A Combined SCT200 Plus Chemotherapy in ESCC and CRC 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 Rate of adverse events. --- I10A --- --- I10A --- --- I10A --- --- I10A ---

Exclusion Criteria: - Patients who were allergic to analogue of SCT-I10A/SCT200 and/or its inactive ingredients, Patients who were allergic to Capecitabine and/or Oxaliplatin were also excluded in cohort3; - Patients have been treated with anti-PD-L1/PD-L2 or anti-PD-1, EGFR antibody or EGFR-TKI; - Within 4 weeks prior to the first dose of study drug, patients have received anti-tumor drugs (such as chemotherapy, endocrine therapy, targeted therapy, immune therapy, tumor embolization). --- I10A ---

HCV RNA [quantitative] is detected); - Prior to the first dose of study drug, patients had toxicity due to previous anti-tumor treatment, which hasn't return to Grade 0-1 according to the NCI CTCAE v5.0; - Has known with alcohol or drug addiction; - Pregnant or lactating women; - Patients who were not willing to accept effective contraceptive measures during treatment and within 6 months after treatment; - Subjects who are considered not suitable for the study by investigator Esophageal Squamous Cell Carcinoma Colorectal Cancer Carcinoma Colorectal Neoplasms Carcinoma, Squamous Cell Esophageal Squamous Cell Carcinoma 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. --- I10A ---

HCV RNA [quantitative] is detected); - Prior to the first dose of study drug, patients had toxicity due to previous anti-tumor treatment, which hasn't return to Grade 0-1 according to the NCI CTCAE v5.0; - Has known with alcohol or drug addiction; - Pregnant or lactating women; - Patients who were not willing to accept effective contraceptive measures during treatment and within 6 months after treatment; - Subjects who are considered not suitable for the study by investigator Esophageal Squamous Cell Carcinoma Colorectal Cancer Carcinoma Colorectal Neoplasms Carcinoma, Squamous Cell Esophageal Squamous Cell Carcinoma 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. --- I10A --- --- I10A ---



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