Neoplasms

All Conditions

Symptoms and General Pathology

Carcinoma

Carcinoma, Squamous Cell

Recurrence

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

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

SCB01A

Hui-Hung Wang, MSc

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

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 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 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.

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.

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).

SynCore Biotechnology Co., Ltd.

The first part of the study involved dose-escalation, in which successive cohorts of 3 patients (expanded to 6 patients in the event of a dose-limiting toxicity) were enrolled and administered 3 cycles of i.v. SCB01A at a dose of 3.25 mg/m² (Dose 1) on Days 1 and 8 of each cycle in a 3-week cycle (Dose 1) until 24 mg/m² (3.25→12→18→24).

Run-in Phase I (Dose Escalation Phase): 3.25 mg/m² (Dose 1)

Run-in Phase I (Dose Escalation Phase): 12 mg/m² (Dose 2)

Run-in Phase I (Dose Escalation Phase):

The first part of the study involved dose-escalation, in which successive cohorts of 3 patients (expanded to 6 patients in the event of a dose-limiting toxicity) were enrolled and administered 3 cycles of i.v. SCB01A at a dose of 3.25 mg/m² (Dose 1) on Days 1 and 8 of each cycle in a 3-week cycle (Dose 1) until 24 mg/m² (3.25→12→18→24). Dose escalation assessment was based on tolerability observed during 3 cycles of treatment.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Asian

Race/Ethnicity, Customized

Taiwan

Region of Enrollment

Measure Description:

ECOG 0: Fully active, able to carry on all pre-disease performance without restriction.

ECOG 1: Restricted in physically strenous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

ECOG 2: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.

Data not collected for 12 mg/m² (Dose 2) cohort as the 2 subjects from the Dose 2 did not complete 3 treatment cycles.

ECOG at Screening visit

Dr. Lin

Disease Control Rate (DCR)

To Assess the Overall Survival Rate

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

Three subjects (expanded to six subjects in the event of a dose-limiting toxicity) were enrolled and administered 3 cycles of i.v. SCB01A at a dose of 3.25 mg/m² (Dose 1) on Days 1 and 8 of each cycle in a 3-week cycle (Dose 1).

SCB01A 3.25 mg/m²

Three subjects (expanded to six subjects in the event of a dose-limiting toxicity) were enrolled and administered 3 cycles of i.v. SCB01A at a dose of 12 mg/m² (Dose 2) on Days 1 and 8 of each cycle in a 3-week cycle (Dose 2).

SCB01A 12 mg/m²

Three subjects (expanded to six subjects in the event of a dose-limiting toxicity) were enrolled and administered 3 cycles of i.v. SCB01A at a dose of 18 mg/m² (Dose 3) on Days 1 and 8 of each cycle in a 3-week cycle (Dose 3).

SCB01A 18 mg/m²

Three subjects (expanded to six subjects in the event of a dose-limiting toxicity) were enrolled and administered 3 cycles of i.v. SCB01A at a dose of 24 mg/m² (Dose 4) on Days 1 and 8 of each cycle in a 3-week cycle (Dose 4).

Spots Global Cancer Trial Database for Study of SCB01A in Patient With Head and Neck Cancer

Trial Identification

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Study Description

Keywords

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