Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCB01A | Experimental | This study is a single arm, open-label, Phase II trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCB01A | Drug | This study is a single arm, open-label, Phase II trial |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hui-Hung Wang, MSc | SynCore Biotechnology Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keelung Chang Gung Memorial Hospital & lovers lake branch | Keelung | Taiwan | ||||
| National Cheng Kung University Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
No subjects were enrolled in Run-in Phase I: Dose 3 (18 mg/m²), Dose 4 (24 mg/m²), and Phase II.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 3.25 mg/m² (Dose 1) on Days 1 and 8 of each cycle in a 3-week cycle (Dose 1). |
| FG001 | 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 12 mg/m² (Dose 2) on Days 1 and 8 of each cycle in a 3-week cycle (Dose 2). |
| FG002 | 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 18 mg/m² (Dose 3) on Days 1 and 8 of each cycle in a 3-week cycle (Dose 3). |
| FG003 | SCB01A 24 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Run-in Phase I (Dose Escalation Phase): 3.25 mg/m² (Dose 1) | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data not collected for 12 mg/m² (Dose 2) cohort as the 2 subjects from the Dose 2 did not complete 3 treatment cycles. | Posted | Count of Participants | Participants | 9 weeks from 1st administrationm drug |
|
From the time of informed consent obtained until 28 days after the last dose of study treatment
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Run-in Phase I (Dose Escalation Phase): 3.25 mg/m² (Dose 1) | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facial pain | General disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lin | Syncore | 0227603688 | JWLin@syncorebio.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 25, 2016 | Apr 12, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 27, 2017 | Apr 12, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| Tainan |
| Taiwan |
| MacKay Memorial Hospital | Taipei | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Linkou Chang Gung Memorial Hospital | Taoyuan | Taiwan |
| Withdrawal by Subject |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| ECOG at Screening visit | 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. | Count of Participants | Participants |
|
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). |
|
|
| Secondary | 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. | Data not collected for 12 mg/m² (Dose 2) cohort as the 2 subjects from the Dose 2 did not complete 3 treatment cycles. | Posted | Median | 95% Confidence Interval | weeks | an expected average of 36 weeks |
|
|
|
| Secondary | 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). | Data not collected for 12 mg/m² (Dose 2) cohort as the 2 subjects from the Dose 2 did not complete 3 treatment cycles. | Posted | Median | 95% Confidence Interval | weeks | an expected average of 12 weeks |
|
|
|
| 1 |
| 3 |
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | Run-in Phase I (Dose Escalation Phase): 12 mg/m² (Dose 2) | 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). | 1 | 2 | 1 | 2 | 2 | 2 |
| Weight decreased | Investigations | Systematic Assessment |
|
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Weight decreased | Investigations | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Feeling cold | General disorders | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| Periodontitis | Infections and infestations | Systematic Assessment |
|
| Delirium | Psychiatric disorders | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Tinea manuum | Infections and infestations | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Salivary gland pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Sialoadenitis | Infections and infestations | Non-systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
Not provided
Not provided
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| 2 |
|