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Study of SCB01A in Patient With Head and Neck Cancer

Primary Purpose

Head and Neck Squamous Cell Carcinoma

Status
Terminated
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
SCB01A
Sponsored by
SynCore Biotechnology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma focused on measuring Head and neck squamous cell carcinoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Confirmed squamous cell carcinoma of head and neck
  2. Patients with nonresectable, unfeasible radiotherapy, recurrent or metastatic carcinoma, after previous treatment with platinum agent.
  3. At least one measurable tumor lesion according to RECIST
  4. Suitable Eastern Cooperative Oncology Group (ECOG) performance status
  5. All eligible patients of childbearing potential have to use effective contraception
  6. Signed informed consent before enrolment

Exclusion Criteria:

  1. Receiving Chemotherapy, radiation therapy, major surgery or investigational agents
  2. Severe pulmonary obstructive or restrictive disease
  3. Uncontrolled inflammatory disease
  4. Clinically significant cardiac disease
  5. Results of laboratory tests
  6. Pregnancy or nursing status
  7. Known hypersensitivity to any component of SCB01A
  8. History of exposure to SCB01A or its analogues
  9. History of malignancy other than head and neck cancer
  10. History of active or significant neurological disorder or psychiatric disorder
  11. Any other reason the investigator deems the patient to be unsuitable for the study

Sites / Locations

  • Keelung Chang Gung Memorial Hospital & lovers lake branch
  • National Cheng Kung University Hospital
  • MacKay Memorial Hospital
  • National Taiwan University Hospital
  • Linkou Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SCB01A

Arm Description

This study is a single arm, open-label, Phase II trial

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).

Full Information

First Posted
June 29, 2015
Last Updated
June 4, 2023
Sponsor
SynCore Biotechnology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02488629
Brief Title
Study of SCB01A in Patient With Head and Neck Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SynCore Biotechnology Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the safety and efficacy of SCB01A in head and neck cancer.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma
Keywords
Head and neck squamous cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SCB01A
Arm Type
Experimental
Arm Description
This study is a single arm, open-label, Phase II trial
Intervention Type
Drug
Intervention Name(s)
SCB01A
Intervention Description
This study is a single arm, open-label, Phase II trial
Primary Outcome Measure Information:
Title
Disease Control Rate (DCR)
Description
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.
Time Frame
9 weeks from 1st administrationm drug
Secondary Outcome Measure Information:
Title
To Assess the Overall Survival Rate
Description
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.
Time Frame
an expected average of 36 weeks
Title
To Assess the Progression-free Survival According to RECIST v.1.1
Description
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).
Time Frame
an expected average of 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui-Hung Wang, MSc
Organizational Affiliation
SynCore Biotechnology Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Keelung Chang Gung Memorial Hospital & lovers lake branch
City
Keelung
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Facility Name
MacKay Memorial Hospital
City
Taipei
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Linkou Chang Gung Memorial Hospital
City
Taoyuan
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of SCB01A in Patient With Head and Neck Cancer

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