Study of SCB01A in Patient With Head and Neck Cancer

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of SCB01A in head and neck cancer.

Detailed Description
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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.

Official Title
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An Open-Label, Phase II Study to Evaluate SCB01A in Patients With Recurrent or Metastatic Squamous Cell Head and Neck Cancer Who Have Received Platinum-Based Treatment

Conditions
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Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: SCB01A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed squamous cell carcinoma of head and neck Patients with nonresectable, unfeasible radiotherapy, recurrent or metastatic carcinoma, after previous treatment with platinum agent. At least one measurable tumor lesion according to RECIST Suitable Eastern Cooperative Oncology Group (ECOG) performance status All eligible patients of childbearing potential have to use effective contraception Signed informed consent before enrolment Exclusion Criteria: Receiving Chemotherapy, radiation therapy, major surgery or investigational agents Severe pulmonary obstructive or restrictive disease Uncontrolled inflammatory disease Clinically significant cardiac disease Results of laboratory tests Pregnancy or nursing status Known hypersensitivity to any component of SCB01A History of exposure to SCB01A or its analogues History of malignancy other than head and neck cancer History of active or significant neurological disorder or psychiatric disorder Any other reason the investigator deems the patient to be unsuitable for the study

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCB01A<br>This study is a single arm, open-label, Phase II trial | Drug: SCB01A<br>* This study is a single arm, open-label, Phase II trial<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control Rate (DCR) | To assess the DCR (=complete response (CR) + partial response (PR) + stable disease (SD)) at the end of the 9th week (3 cycles, each cycle consisted of 21 days) after treatment with SCB01A, according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sumdiameterswhile on study. | 9 weeks from 1st administrationm drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Assess the Overall Survival Rate | 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. | an expected average of 36 weeks | 
| To Assess the Progression-free Survival According to RECIST v.1.1 | RECIST v.1.1: Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | an expected average of 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and neck squamous cell carcinoma