Study of SCB01A in Patient With Head and Neck Cancer

SynCore Biotechnology

Status and phase: Terminated; Phase 2

Conditions: Head and Neck Squamous Cell Carcinoma

Treatments: Drug: SCB01A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02488629

SCB01A-21

Details and patient eligibility

About

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

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

SCB01A

Experimental group

Description:

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

Treatment:

Drug: SCB01A