Study of SCB01A in Patient With Head and Neck Cancer

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

To evaluate the safety and efficacy of SCB01A in head and neck cancer.

Study Overview

• Status: Terminated
• Conditions: Head and Neck Squamous Cell Carcinoma
• Intervention / Treatment: Drug: SCB01A

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Keelung, Taiwan
    • Keelung Chang Gung Memorial Hospital & lovers lake branch
  • Tainan, Taiwan
    • National Cheng Kung University Hospital
  • Taipei, Taiwan
    • Mackay Memorial Hospital
  • Taipei, Taiwan
    • National Taiwan University Hospital
  • Taoyuan, Taiwan
    • Linkou Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SCB01A; This study is a single arm, open-label, Phase II trial	Drug: SCB01A; This study is a single arm, open-label, Phase II trial

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: SynCore Biotechnology Co., Ltd.
• Investigators: Study Director: Hui-Hung Wang, MSc, SynCore Biotechnology Co., Ltd.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: June 29, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimated): July 2, 2015

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 4, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Head and neck squamous cell carcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Head and Neck Neoplasms; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: SCB01A-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO