Study of SCB01A in Patient With Head and Neck Cancer

Phase 2

Terminated

• Conditions: Head and Neck Squamous Cell Carcinoma
• Interventions: Drug: SCB01A

• Registration Number: NCT02488629
• Lead Sponsor: SynCore Biotechnology Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2015-06-29
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-02
• Study Start: 2015-09
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Results First Submitted: 2023-04-12
• Status Verified: 2023-06
• Results First Submitted QC: 2023-06-04
• Last Update Submitted: 2023-06-04
• Results First Posted: 2023-06-27
• Last Update Posted: 2023-06-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SCB01A	SCB01A	This study is a single arm, open-label, Phase II trial

Primary Outcome Measures

Name	Time	Method
Disease Control Rate (DCR)	9 weeks from 1st administrationm drug	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

Name	Time	Method
To Assess the Overall Survival Rate	an expected average of 36 weeks	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	an expected average of 12 weeks	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).

Trial Locations

Locations (5)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Linkou Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

Keelung Chang Gung Memorial Hospital & lovers lake branch; 🇨🇳 Keelung, Taiwan

MacKay Memorial Hospital; 🇨🇳 Taipei, Taiwan