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Esophageal Squamous Cell CarcinomaPhase 1NCT04229537

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

A Phase 1 study testing SCT-I10A, SCT200 and Chemotherapy in people with Esophageal Squamous Cell Carcinoma and Colorectal Cancer, run by Sinocelltech Ltd..

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 The sponsor has not verified this record for over two years, so it may be out of date.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 safety and efficacy of SCT-I10A combined SCT200 or SCT-I10A combined SCT200 plus chemotherapy in advanced esophageal squamous cell carcinoma and colorectal cancer Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
SCT-I10A, SCT200 and Chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
1 Mar 2020to 1 Dec 2022
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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;
  • Within 5 year prior to the first dose of study drug, patients have other primary malignancies;
  • Have a history of HIV;
  • Patients with a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
  • Has known active Hepatitis B (e.g. HBsAg reactive) or Hepatitis C(e.g. 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

Trial locations and contacts

No sites are listed yet.

Foxiao Qiao, Ph D contact

18911165421

Foxiao_qiao@sinocelltech.com

About this study

Official title: 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

Read the detailed description

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.

Being tested
SCT-I10A, SCT200, Chemotherapy
Keywords
SCT-I10A, SCT200
Medical subject headings
Esophageal Squamous Cell Carcinoma, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SCT-I10ABiological

    200 mg intravenous (IV) on Day 1 of Q3W.

  • SCT200Biological

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

  • ChemotherapyOther

    Capecitabine and Oxaliplatin.

Study groups in NCT04229537
Study groupRoleWhat they receive
SCT-I10A combined SCT200 in ESCCExperimentalSCT-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
Receives: Biological: SCT-I10A; Biological: SCT200
SCT-I10A combined SCT200 in CRCExperimentalSCT-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
Receives: Biological: SCT-I10A; Biological: SCT200
SCT-I10A combined SCT200 plus Chemotherapy in CRCExperimentalSCT-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.
Receives: Biological: SCT-I10A; Biological: SCT200; Other: Chemotherapy

What is being measured

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

  1. Rate of adverse events

    Including adverse events and safety of laboratory tests

    Measured: 24 months

Secondary outcomes (5)

  1. Objective response rate (ORR)

    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

    Measured: 24 months

  2. Duration of response (DOR)

    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

    Measured: 24 months

  3. Disease control rate (DCR)

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

    Measured: 24 months

  4. Progression free survival (PFS)

    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

    Measured: 24 months

  5. Overall survival (OS)

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

    Measured: 24 months

Timeline

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

  1. First posted18 Jan 2020
  2. Study start1 Mar 2020 (estimated)
  3. Primary completion1 Aug 2022 (estimated)
  4. Study completion1 Dec 2022 (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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04229537
Sponsor's protocol ID
SCT-I10A-X102
Status last verified
Jan 2020
First submitted
9 Jan 2020
Last updated
18 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40819238

  • Bai 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.

    PubMed 38148327

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SCT-I10A, SCT200 and Chemotherapy in people with Esophageal Squamous Cell Carcinoma and 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 9 inclusion and 24 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 18 Jan 2020. 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?

Contact Foxiao Qiao, Ph D (18911165421, Foxiao_qiao@sinocelltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of adverse events (time frame: 24 months). 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 NCT04229537, which also lists 2 linked publications.

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 18 Jan 2020.

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Clinical Trial NCT04229537 | AzTrials