Study of SCB01A in Patient With Head and Neck Cancer

NCT02488629 | Terminated Phase 2 Results DMC

• 1 other identifier: SCB01A-21
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Head and neck squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To Assess the Overall Survival Rate

  an expected average of 36 weeks

• To Assess the Progression-free Survival According to RECIST v.1.1

  an expected average of 12 weeks

Study Arms (1)

SCB01A

EXPERIMENTAL

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

Drug: SCB01A

Interventions

SCB01A DRUG

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

SCB01A

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SynCore Biotechnology Co., Ltd.: lead

Study Sites (5)

Keelung Chang Gung Memorial Hospital & lovers lake branch

Keelung, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

MacKay Memorial Hospital

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

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

Results Point of Contact

• Title: Dr. Lin
• Organization: Syncore

JWLin@syncorebio.com

0227603688

Study Officials

• Hui-Hung Wang, MSc

  SynCore Biotechnology Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

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: June 29, 2015
• First Posted: July 2, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 27, 2023
• Results First Posted: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (5)