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Safety and Efficacy of SCT-I10A in Head and Neck Squamous Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT04146181
Recruitment Status : Recruiting
First Posted : October 31, 2019
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
Sinocelltech Ltd.

Brief Summary:
The objective of this study is to evaluate the efficacy and safety of SCT-I10A for Recurrent/ Metastatic Head and Neck Squamous cell Carcinoma who progressed on or after platinum-based chemotherapy

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Drug: PD-1 Phase 2

Detailed Description:
This is an open label, single-arm and multicenter phase II study designed to evaluate Objective Response Rate (ORR) of SCT-I10A for Recurrent/ Metastatic Head and Neck Squamous cell Carcinoma who progressed on or after platinum-based chemotherapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 103 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Single-arm, Open-label Study of SCT-I10A in Patients With Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma Who Progressed on or After Platinum-based Chemotherapy
Actual Study Start Date : October 31, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SCT-I10A
SCT-I10A, 200 mg intravenous (IV) on Day 1 of each 3-week cycle.
Drug: PD-1
SCT-I10A, 200 mg intravenous (IV) on Day 1 of each 3-week cycle.
Other Name: SCT-I10A




Primary Outcome Measures :
  1. ORR [ Time Frame: 1 year ]
    ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 during trial treatment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Voluntarily participate in this clinical trial and sign an informed consent form;
  2. Male or female, age ≥ 18 years old;
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  4. Has histologically- or cytologically-confirmed recurrent or metastatic (disseminated) head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx;
  5. Is considered incurable by local therapies;
  6. Have measurable disease based on RECIST1.1. tumor lesions, situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesion after 3 months of radiotherapy;
  7. Have provided tissue for PD-L1 biomarker analysis
  8. The estimated survival period is ≥ 3 months;
  9. Patients who have been treated with platinum (cisplatin/carboplatin/nidaplatin) and have clear disease progression during treatment (at least 2 cycles) or after treatment (see RECIST version 1.1) or side effects Intolerance, and the minimum dose of platinum drugs must meet:

    Minimum dose of cisplatin: ≥60mg/m2 per cycle, or ≥120mg/m2 in 8 weeks; The minimum dose of carboplatin: AUC ≥ 4 / cycle, or total AUC ≥ 8 within 8 weeks.

    If cisplatin is converted to platinum, the platinum dosage can be calculated using the following formula: carboplatin 1AUC = cisplatin 15mg/m2; The minimum dose of nedaplatin: ≥80mg/m2 per cycle, or ≥160mg/m2 in 8 weeks; Note: Platinum drugs can be used as adjuvant therapy for postoperative patients (synchronous radiotherapy), for palliative chemotherapy in patients with advanced stage or in patients with recurrent and/or metastatic disease.

  10. Laboratory inspection:

    Blood routine: neutrophils ≥1.5×l09/L, platelets≥75×109/L, hemoglobin≥80g/L; Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST), ALT and AST ≤ upper limit of normal value × 3 for liver metastasis, ALT and AST ≤ upper limit of normal value for liver metastases × 5; total bilirubin ( TBIL) ≤ upper limit of normal value × 1.5; Renal function: creatinine (Cr) ≤ normal upper limit × 1.5; Coagulation: Activated Partial Thromboplastin Time (aPTT), International Normalized Ratio (INR), Prothrombin Time (PT) ≤1.5xULN Echocardiogram: LVEF≥50%

  11. Subjects should agree to use an adequate method of contraception starting with the first dose of study medication through 6 months after the last dose of study therapy. Female subjects of childbearing potential should have a negative blood pregnancy test within 7 days prior to receiving the first dose of study medication, and should be non-breastfeeding;

Exclusion Criteria:

  1. Disease is suitable for local therapy administered with curative intent
  2. Prior therapy with an anti-PD-1 or anti-PD1-L1 or -L2 therapy, or anti-CD137, or anti-CTLA-4 therapy
  3. Diagnosed and/or treated additional malignancy within 5 years of randomization, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin, and/or curatively-resected in situ cervical cancers;
  4. NCI CTCAE v5.0 Grading of Peripheral Neuropathy≥2;
  5. 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 BM (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;
  6. At the time of enrollment, patients still had ≥2 toxic side effects (except for hair loss, hearing loss, tinnitus, dry mouth or platinum-induced grade 2 neurotoxicity) caused by previous anti-tumor treatment;
  7. Has known serious allergic reaction to study medication or any component of the product, and has known serious allergic reaction to other monoclonal antibodies (NCI CTCAE v5.0≥3);
  8. Has received anti-tumor therapy, including chemotherapy, hormonal therapy, immunotherapy, radiotherapy, and etc. within 4 weeks of the first dose of treatment, except palliative radiotherapy for bone pain;
  9. Has received any Chinese traditional medicine for anti-cancer purpose within 1 week of the first dose of treatment;
  10. Has undergone important surgery within 4 weeks prior to first dose of treatment or has scheduled an important surgery during the study;
  11. Has received immunosuppressive drugs during the study or within 2 weeks prior to first dose of treatment, except for the following situations:

    Intranasal, inhaled, topical corticosteroids (e.g. intra-articular injections); Physiological dose for systemic prednisolone (≤10mg/d or equivalent); Short-term administration (≤7days) of corticosteroids for prophylaxis or treatment against non-autoimmune allergic disease

  12. Has known active, and/ or history of autoimmune disease (systemic lupus erythematous, rheumatoid arthritis, inflammatory bowel disease, AITD, multiple sclerosis, vasculitis, glomerulonephritis), and is likely to get a recurrence, or is at high-risk (organ-transplanted patients need immunotherapy), except those with stable type 1 DM after fixed dose of insulin administration , or those with autoimmune hypothyroidism only require HRT, or those with skin disorders that does not require systemic treatment (e.g. eczema, rash <10% BSA, psoriasis without symptoms around eyes)
  13. Has known interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, except asymptomatic drug-induced pneumonitis or radiation pneumonitis
  14. Has a known history of HIV
  15. Has known active Hepatitis B (e.g. HBsAg reactive) or Hepatitis C(e.g. HCV RNA [quantitative] is detected)
  16. has uncontrolled active infections within 2 weeks before enrollment
  17. Has received a live vaccine within 4 weeks prior to first dose of study treatment, except
  18. Is with clinical symptoms, required clinical intervention or stable time less than 4 weeks of serous cavity effusion (such as pleural effusion and ascites);
  19. Has severe conditions, including NYHA III heart failure, IHD, history of MI within 3 months prior to first dose of study treatment, poorly controlled DM (FBS≥10mmol/L) or poorly controlled hypertension (SBP≥160mmHg and/ or DBP≥100mmHg)
  20. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  21. Is currently participating in other clinical trials, or has participated in a study of an investigational agent and received study therapy, or used an investigational device, any of whose end date is within 4 weeks prior to the first dose of study medication
  22. has alcohol or drug addiction;
  23. Subjects who are considered unsuitable for participating in this study for various reasons at the discretion of the investigator,such as inability to comply with study and/or follow-up procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04146181


Contacts
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Contact: Yan Wang, MD 15201286305 SCT-CT@sinocelltech.com
Contact: Yuankai Shi, MD

Locations
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China, Guangxi
Guangxi Medical University Affiliated Tumour Hospital Recruiting
Nanning, Guangxi, China
Contact: Song Qu, PhD       13607887386@163.com   
Sponsors and Collaborators
Sinocelltech Ltd.
Investigators
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Principal Investigator: Yuankai Shi, MD Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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Responsible Party: Sinocelltech Ltd.
ClinicalTrials.gov Identifier: NCT04146181    
Other Study ID Numbers: SCT-I10A-B201
First Posted: October 31, 2019    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site