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

NCT04146181 | Unknown Phase 2

• 1 other identifier: SCT-I10A-B201
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• ORR

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

  1 year

Study Arms (1)

SCT-I10A

EXPERIMENTAL

SCT-I10A, 200 mg intravenous (IV) on Day 1 of each 3-week cycle.

Drug: PD-1

Interventions

PD-1 DRUG

SCT-I10A, 200 mg intravenous (IV) on Day 1 of each 3-week cycle.

Also known as: SCT-I10A

SCT-I10A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate in this clinical trial and sign an informed consent form;
• Male or female, age ≥ 18 years old;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Has histologically- or cytologically-confirmed recurrent or metastatic (disseminated) head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx;
• Is considered incurable by local therapies;
• 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;
• Have provided tissue for PD-L1 biomarker analysis
• The estimated survival period is ≥ 3 months;
• 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.
• 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%
• 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;

You may not qualify if:

• Disease is suitable for local therapy administered with curative intent
• Prior therapy with an anti-PD-1 or anti-PD1-L1 or -L2 therapy, or anti-CD137, or anti-CTLA-4 therapy
• 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;
• NCI CTCAE v5.0 Grading of Peripheral Neuropathy≥2;
• 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;
• 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;
• 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);
• 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;
• Has received any Chinese traditional medicine for anti-cancer purpose within 1 week of the first dose of treatment;
• Has undergone important surgery within 4 weeks prior to first dose of treatment or has scheduled an important surgery during the study;
• 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
• 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)
• Has known interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, except asymptomatic drug-induced pneumonitis or radiation pneumonitis
• Has a known history of HIV

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

Guangxi Medical University Affiliated Tumour Hospital

Nanning, Guangxi, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Yuankai Shi, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Wang, MD

CONTACT

15201286305; SCT-CT@sinocelltech.com

Yuankai Shi, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 31, 2019
• Study Start: October 31, 2019
• Primary Completion: June 30, 2021
• Study Completion: September 30, 2021
• Last Updated: December 12, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)