Squamous Cell Head and Neck Cancer

The study is designed to evaluate the safety and efficacy of SCB01A in patients with recurrent or metastatic squamous cell carcinoma in head and neck. Primary Objective: To assess the disease control rate (DCR) at the end of the 9th week (3 cycles, each cycle consists of 21 days) after treatment with SCB01A, according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Secondary Objectives:  To assess the overall survival (OS) rate at 36 weeks after first treatment with SCB01A in patients with recurrent or metastatic squamous cell head and neck cancer who have previously been treated with platinum therapy.  To assess the progression-free survival (PFS)  To determine the recommended dose regimen of SCB01A for further investigation in different settings of head and neck squamous cell cancer.  To assess the safety and toxicity profile of study treatment.  To assess the PK profile of SCB01A of patients in the run-in phase.  To assess health outcomes using patient-reported European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) and EORTC QLQ H&N35 questionnaires.  To assess biomarkers relevant to the efficacy and mechanism of action of SCB01A.  To explore the possible association between biomarkers and clinical outcomes

SCB01A

6-Methoxy-3-(3,4,5-trimethoxybenzoyl) indole

Injection

10 mg/mL, 5 mL/vial

Primary endpoint:
 DCR, defined as; complete response (CR) + partial response (PR) +
stable disease (SD) at Week 9, according to RECIST v1.1 criteria
Secondary endpoints:
 PFS
 OS rate at 36 weeks after first treatment with SCB01A
 Safety: The safety endpoints used to achieve the secondary
objectives of this study are:
o Hematology, clinical chemistry, coagulation factors and
urinalysis laboratory data changes
o AE/SAE incidence
o Physical examination result changes
o Vital sign changes
o Electrocardiogram (ECG) (including PR, QRS, QT, QTc,
and RR intervals) results
Health outcomes assessment using patient-reported EORTC
QLQ-C30 and H&N35 questionnaires.

Inclusion Criteria:
1. Aged ≥20 years.
2. Histological or cytological confirmed squamous cell carcinoma of
head and neck.
3. Recurrent or metastatic disease after previous treatment with
platinum agent.
4. At least one measurable tumor lesion according to RECIST
version 1.1 as assessed by the investigator (local radiological image
assessment).
5. Eastern Cooperative Oncology Group (ECOG) performance status
of 0, 1 or 2.
6. Life expectancy of 12 weeks or longer.
7. Patients must have radiological measurable or clinically evaluable
disease. Physical examination and radiographic studies have to be
performed within 28 days of enrolment.
8. Concurrent local therapy is not allowed, but concurrent palliative
radiation therapy to non-measurable sites of disease such as painful
bone metastasis is permitted.
9. All eligible patients of childbearing potential have to use effective
contraception; that is, double barrier contraceptive methods.
10. Signed informed consent before enrolment.
11. Documented progressive disease within past 6 months.

Exclusion Criteria:
1. Nasopharyngeal carcinoma, brain metastasis or known progressive
cerebral metastasis confirmed by magnetic resonance imaging
(MRI) (patients with cerebral metastases in a stable state or after
successful surgical or radiological treatment are allowed to
participate in the study).
2. Chemotherapy, radiation therapy, major surgery or investigational
agents less than 4 weeks prior to study drug treatment.
3. Ultrasound or radiological evidence of liver cirrhosis.
4. Severe pulmonary obstructive or restrictive disease.
5. Uncontrolled inflammatory disease (autoimmune or infectious).
6. Clinically significant cardiac disease (NYHA class > 2).
7. Results of laboratory tests (hematology, coagulation, clinical
chemistry) or organ function outside specified limits:
a. White blood cell (WBC) ≤ 3 x 109
/L
b. Absolute neutrophil count (ANC) ≤ 1.5 x 109
/L
c. Platelets ≤ 75 x 109
/L
d. Hemoglobin (Hb) ≤ 9.0 g/dl (≤ 5.6 mmol/l)
e. Prothrombin time (PT)/international normalized ratio
(INR)> 1.5 x upper limit of normal (ULN)
f. Aspartate aminotransferase (AST) or alanine aminotransferase
(ALT) > 2.5 x ULN
g. Alkaline Phosphatase (ALP) > 2.5 x ULN
h. Albumin < 3.0 g/dl
i. Total Bilirubin > 1.5 x ULN
j. Serum creatinine > 2.5 x ULN
k. QTc > 450 msec
8. Pregnancy or nursing status.
9. Known hypersensitivity to any component of SCB01A.
10. History of exposure to SCB01A or its analogues.
11. History of malignancy other than head and neck cancer. Second
primary head and neck tumors are excluded with the exception of
early stage non-melanoma skin cancer or carcinoma in situ of cervix.
12. History of active or significant neurological disorder or psychiatric
disorder that would prohibit the understanding and giving of
informed consent, or would interfere with the clinical and
radiological evaluation of central nervous system during the trial.
13. Any other reason the investigator deems the patient to be unsuitable
for the study.