Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
Head and neck squamous cell carcinoma
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.
Interventions
DRUGSCB01A
This study is a single arm, open-label, Phase II trial
Sponsors
SynCore Biotechnology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Taiwan
Participant flow
Pre-assignment details
No subjects were enrolled in Run-in Phase I: Dose 3 (18 mg/m²), Dose 4 (24 mg/m²), and Phase II.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| 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. | 2 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 3 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | 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) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 2 Participants | 5 Participants |
| Age, Continuous | 56.3 years | 53.5 years | 55.2 years |
| ECOG at Screening visit 0 | 0 Participants | — | 0 Participants |
| ECOG at Screening visit 1 | 2 Participants | — | 2 Participants |
| ECOG at Screening visit 2 | 1 Participants | — | 1 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 2 Participants | 5 Participants |
| Region of Enrollment Taiwan | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 3 | 1 / 2 |
| other Total, other adverse events | 3 / 3 | 2 / 2 |
| serious Total, serious adverse events | 1 / 3 | 1 / 2 |
Outcome results
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.
Time frame: 9 weeks from 1st administrationm drug
Population: Data not collected for 12 mg/m² (Dose 2) cohort as the 2 subjects from the Dose 2 did not complete 3 treatment cycles.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Run-in Phase I (Dose Escalation Phase): 3.25 mg/m² (Dose 1) | Disease Control Rate (DCR) | Complete Response (CR) | 0 Participants |
| Run-in Phase I (Dose Escalation Phase): 3.25 mg/m² (Dose 1) | Disease Control Rate (DCR) | Partial Response (PR) | 0 Participants |
| Run-in Phase I (Dose Escalation Phase): 3.25 mg/m² (Dose 1) | Disease Control Rate (DCR) | Stable Disease (SD) | 1 Participants |
| Run-in Phase I (Dose Escalation Phase): 3.25 mg/m² (Dose 1) | Disease Control Rate (DCR) | Progressive Disease (PD) | 2 Participants |
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.
Time frame: an expected average of 36 weeks
Population: Data not collected for 12 mg/m² (Dose 2) cohort as the 2 subjects from the Dose 2 did not complete 3 treatment cycles.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Run-in Phase I (Dose Escalation Phase): 3.25 mg/m² (Dose 1) | To Assess the Overall Survival Rate | 25.57 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).
Time frame: an expected average of 12 weeks
Population: Data not collected for 12 mg/m² (Dose 2) cohort as the 2 subjects from the Dose 2 did not complete 3 treatment cycles.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Run-in Phase I (Dose Escalation Phase): 3.25 mg/m² (Dose 1) | To Assess the Progression-free Survival According to RECIST v.1.1 | 8.71 weeks |