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
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2020
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2020
CompletedFirst Posted
Study publicly available on registry
January 18, 2020
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJanuary 18, 2020
January 1, 2020
2.4 years
January 9, 2020
January 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of adverse events
Including adverse events and safety of laboratory tests
24 months
Secondary Outcomes (5)
Objective response rate (ORR)
24 months
Duration of response (DOR)
24 months
Disease control rate (DCR)
24 months
Progression free survival (PFS)
24 months
Overall survival (OS)
24 months
Study Arms (3)
SCT-I10A combined SCT200 in ESCC
EXPERIMENTALSCT-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 combined SCT200 in CRC
EXPERIMENTALSCT-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 combined SCT200 plus Chemotherapy in CRC
EXPERIMENTALSCT-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.
Interventions
200 mg intravenous (IV) on Day 1 of Q3W.
6mg/kg intravenous (IV) on Day 1 of QW, then 8mg/kg intravenous (IV) on Day 1 of Q2W
Eligibility Criteria
You may qualify if:
- Able to provide written informed consent before screening；
- Males or females. Aged 18 to 75 years old;
- Life expectancy≥12 weeks before starting treatment (clinical assessment);
- With an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
- Histologically or cytologically confirmed advanced esophageal squamous cell carcinoma or colorectal cancer;
- Patients with advanced esophageal squamous cell carcinoma undergoing first-line systemic chemotherapy progression or intolerance were included in Arm 1; Patients with RAS and BRAF wild-type advanced colorectal cancer undergoing at least second line systemic chemotherapy progression or intolerance were included in Arm 2; Patients with RAS and BRAF wild-type advanced colorectal cancer untreated with cetuximab were included in Arm 3;
- According to RECIST 1.1, patients must have at least one measurable lesion that can be accurately assessed;
- Adequate organ and bone marrow function as defined below:
- Absolute neutrophil count (ANC) greater than/equal to 1.5×l09/L; Platelets greater than/equal to 100×109/L; Hemoglobin greater than/equal to 90g/L; Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than/equal to 3 times ULN, or less than/equal to 5 times ULN if known liver metastases; Total bilirubin less than/equal to 1.5 times ULN; Serum creatinine less than/equal to 1.5 times ULN or Ccr\>60ml/min; Thyroid stimulating hormone (TSH) hormone levels less than/equal to ULN; Serum magnesium greater than/equal to ULN; APTT, INR, PT less than/equal to 1.5 times ULN.
You may not qualify if:
- 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). Within 6 weeks prior to the first dose of study drug, patients have been treated with biological products, nitrosourea or mitomycin C. Within 4 weeks prior to the first dose of study drug, patients have been treated with tumor embolization or radiotherapy;
- Within 2 weeks prior to the first dose of study drug, patients have received corticosteroids or other immunosuppressive agents;
- Within 1 month prior to the first dose of study drug, patients have received live attenuated vaccine (LAV);
- Patients are currently enrolled in other research devices or in research drugs, or less than 4 weeks from other research drugs or devices;
- Patients with significant malnutrition. Patients will be excluded if they are receiving intravenous hyperalimentation, or require continuous infusion therapy with hospitalization. Patients whose nutrition has been well controlled for ≥ 28 days prior to randomization may be enrolled.
- Within 4 weeks prior to the first dose of study drug, patients have received major surgery, or had wounds, ulcers or fractures that haven't healed; Within 6 weeks prior to the first dose of study drug, patients were suffering with gastrointestinal perforation or fistula;
- Has active infection or fever of unknown origin(\> 38.5℃)；
- Has invaded large vessels and weasand
- Active central nervous system (CNS) metastases and/or carcinomatous meningitis; subjects with previous treated brain metastases may participate provided they are stable for at least 2 weeks prior to the first dose of study medication, have no evidence of new or enlarging brain metastases, and are not using steroids for at least 14 days prior to trial treatment. Subjects with asymptomatic brain metastases (without neurological symptoms, not using steroids, tumor lesions≤1.5cm) may participate in condition that the tumor lesion should be regularly evaluated using identical imaging modality for each assessment, either MRI or CT scans;
- Patients with clinical symptoms, required clinical intervention or stable time less than 4 weeks of serous cavity effusion (such as pleural effusion and ascites);
- Poorly controlled hypetension. Within 6 months prior to study, patients had uncontrolled concurrent diseases, including but not limited to acute myocardial infarction, unstable angina pectoris, stroke, or transient ischemic attack, congestive heart failure (NYHA, greater than II), left ventricular ejection fraction (LVEF) \<50%, and with related heart disease.
- Patients who have interstitial lung disease or imaging features of interstitial pneumonia, or who have history of non-infectious pneumonia treated with corticosteroids.
- Patients with an active, known or suspected autoimmune disease or a history of autoimmune disease;
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Bai M, Lu Y, Shen L, Yin X, Gao S, Xia B, Fu Z, Zhang Z, Xie L, Ba Y. Anti-PD-1 antibody (SCT-I10A) plus anti-EGFR antibody (SCT200) in patients with advanced esophageal squamous cell carcinoma: A multicenter, open-label, phase 1b clinical trial. Cancer. 2025 Aug 15;131(16):e70046. doi: 10.1002/cncr.70046.
PMID: 40819238DERIVEDBai M, Lu Y, Shi C, Yang J, Li W, Yin X, Huang C, Shen L, Xie L, Ba Y. Phase Ib study of anti-EGFR antibody (SCT200) in combination with anti-PD-1 antibody (SCT-I10A) for patients with RAS/BRAF wild-type metastatic colorectal cancer. Cancer Biol Med. 2023 Dec 23;21(7):636-50. doi: 10.20892/j.issn.2095-3941.2023.0301.
PMID: 38148327DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yi Ba, MD
Tianjin Medical University Cancer Institute and Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2020
First Posted
January 18, 2020
Study Start
March 1, 2020
Primary Completion
August 1, 2022
Study Completion
December 1, 2022
Last Updated
January 18, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share