Trial Outcomes & Findings for To Evaluate the Efficacy and Safety of SCB01A in Subjects With r/m Squamous Cell Head and Neck Cancer (NCT NCT03020823)
NCT ID: NCT03020823
Last Updated: 2023-06-05
Results Overview
Objective response rate (ORR) was defined as complete response (CR) + partial response (PR), according to RECIST v1.1 criteria. 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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Up to approximately 15 months (assessed continuously during treatment)
Results posted on
2023-06-05
Participant Flow
Participant milestones
| Measure |
Intra-subject Dose Escalation Regimen
All subjects enrolled in this study would be treated from the same starting dose 12 mg/m² (Dose 1) given on Days 1 and 8 in a 21-day cycle by 24 h i.v. infusion. If the subject experiences no dose-limiting toxicity (DLT) during the period, dose escalation of SCB01A to 18 mg/m² (Dose 2) occurred from cycle 2; and increased to 24 mg/m² (Dose 3) on cycle 3.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
12 mg/m² Only
|
3
|
|
Overall Study
12 & 18 mg/m²
|
4
|
|
Overall Study
12, 18 & 24 mg/m²
|
3
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Intra-subject Dose Escalation Regimen
All subjects enrolled in this study would be treated from the same starting dose 12 mg/m² (Dose 1) given on Days 1 and 8 in a 21-day cycle by 24 h i.v. infusion. If the subject experiences no dose-limiting toxicity (DLT) during the period, dose escalation of SCB01A to 18 mg/m² (Dose 2) occurred from cycle 2; and increased to 24 mg/m² (Dose 3) on cycle 3.
|
|---|---|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
Lack of Efficacy
|
4
|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
To Evaluate the Efficacy and Safety of SCB01A in Subjects With r/m Squamous Cell Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
SCB01A Alone
n=10 Participants
intra-subject dose escalation starting from 12 mg/m2, then to18 mg/m2, and finally to 24 mg/m2 if no DLT
SCB01A: intra-subject dose escalation, 12, 18, 24 mg/m2, 24h-IV infusion (in the vein) on day 1 and 8 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
10 participants
n=5 Participants
|
|
ECOG at Screening visit
0
|
4 Participants
n=5 Participants
|
|
ECOG at Screening visit
1
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 15 months (assessed continuously during treatment)Objective response rate (ORR) was defined as complete response (CR) + partial response (PR), according to RECIST v1.1 criteria. 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.
Outcome measures
| Measure |
SCB01A Alone
n=10 Participants
intra-subject dose escalation starting from 12 mg/m2, then to18 mg/m2, and finally to 24 mg/m2 if no DLT
SCB01A: intra-subject dose escalation, 12, 18, 24 mg/m2, 24h-IV infusion (in the vein) on day 1 and 8 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
|
|---|---|
|
Objective Response Rate (ORR) During Treatment Phase
|
0 Participants
|
SECONDARY outcome
Timeframe: From the start of treatment up to either first observation of progressive disease or occurrence of death, up to approximately 15 months (assessed continuously during treatment)PFS is defined as the time from the start of treatment up to the date of first progression based on RECIST v1.1 or the date of death, which ever comes first. 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).
Outcome measures
| Measure |
SCB01A Alone
n=10 Participants
intra-subject dose escalation starting from 12 mg/m2, then to18 mg/m2, and finally to 24 mg/m2 if no DLT
SCB01A: intra-subject dose escalation, 12, 18, 24 mg/m2, 24h-IV infusion (in the vein) on day 1 and 8 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
|
|---|---|
|
Progression Free Survival (PFS)
|
125 days
Interval 28.0 to 251.0
|
SECONDARY outcome
Timeframe: From the start of treatment up to death from any cause or last day known to be alive, up to approximately 15 months (assessed continuously during treatment)OS is defined as the as the time from the start of treatment up to the time that the subject is still alive.
Outcome measures
| Measure |
SCB01A Alone
n=10 Participants
intra-subject dose escalation starting from 12 mg/m2, then to18 mg/m2, and finally to 24 mg/m2 if no DLT
SCB01A: intra-subject dose escalation, 12, 18, 24 mg/m2, 24h-IV infusion (in the vein) on day 1 and 8 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
|
|---|---|
|
Overall Survival (OS)
|
292 days
Interval 29.0 to 292.0
|
SECONDARY outcome
Timeframe: Up to approximately 15 months (assessed continuously during treatment)Best overall tumor response is defined as an objective response or stable disease of treatment phase.
Outcome measures
| Measure |
SCB01A Alone
n=10 Participants
intra-subject dose escalation starting from 12 mg/m2, then to18 mg/m2, and finally to 24 mg/m2 if no DLT
SCB01A: intra-subject dose escalation, 12, 18, 24 mg/m2, 24h-IV infusion (in the vein) on day 1 and 8 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
|
|---|---|
|
Best Overall Tumor Response
|
3 Participants
|
Adverse Events
SCB01A 12 mg/m² Only
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
SCB01A 12 & 18 mg/m²
Serious events: 2 serious events
Other events: 4 other events
Deaths: 2 deaths
SCB01A 12, 18 & 24 mg/m²
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SCB01A 12 mg/m² Only
n=3 participants at risk
All subjects enrolled in this study would be treated from the same starting dose 12 mg/m² (Dose 1) given on Days 1 and 8 in a 21-day cycle by 24 h i.v. infusion. If the subject experiences no dose-limiting toxicity (DLT) during the period, dose escalation of SCB01A to 18 mg/m² (Dose 2) occurred from cycle 2; and increased to 24 mg/m² (Dose 3) on cycle 3.
|
SCB01A 12 & 18 mg/m²
n=4 participants at risk
All subjects enrolled in this study would be treated from the same starting dose 12 mg/m² (Dose 1) given on Days 1 and 8 in a 21-day cycle by 24 h i.v. infusion. If the subject experiences no dose-limiting toxicity (DLT) during the period, dose escalation of SCB01A to 18 mg/m² (Dose 2) occurred from cycle 2; and increased to 24 mg/m² (Dose 3) on cycle 3.
|
SCB01A 12, 18 & 24 mg/m²
n=3 participants at risk
All subjects enrolled in this study would be treated from the same starting dose 12 mg/m² (Dose 1) given on Days 1 and 8 in a 21-day cycle by 24 h i.v. infusion. If the subject experiences no dose-limiting toxicity (DLT) during the period, dose escalation of SCB01A to 18 mg/m² (Dose 2) occurred from cycle 2; and increased to 24 mg/m² (Dose 3) on cycle 3.
|
|---|---|---|---|
|
Nervous system disorders
somnolence
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
25.0%
1/4 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
|
Infections and infestations
pneumonia
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
25.0%
1/4 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
1/3 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/4 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
|
Hepatobiliary disorders
hepatic function abnormal
|
33.3%
1/3 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/4 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
|
Respiratory, thoracic and mediastinal disorders
airway obstruction
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
25.0%
1/4 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
|
Nervous system disorders
syncope
|
33.3%
1/3 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/4 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
|
Nervous system disorders
dizziness
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
25.0%
1/4 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
Other adverse events
| Measure |
SCB01A 12 mg/m² Only
n=3 participants at risk
All subjects enrolled in this study would be treated from the same starting dose 12 mg/m² (Dose 1) given on Days 1 and 8 in a 21-day cycle by 24 h i.v. infusion. If the subject experiences no dose-limiting toxicity (DLT) during the period, dose escalation of SCB01A to 18 mg/m² (Dose 2) occurred from cycle 2; and increased to 24 mg/m² (Dose 3) on cycle 3.
|
SCB01A 12 & 18 mg/m²
n=4 participants at risk
All subjects enrolled in this study would be treated from the same starting dose 12 mg/m² (Dose 1) given on Days 1 and 8 in a 21-day cycle by 24 h i.v. infusion. If the subject experiences no dose-limiting toxicity (DLT) during the period, dose escalation of SCB01A to 18 mg/m² (Dose 2) occurred from cycle 2; and increased to 24 mg/m² (Dose 3) on cycle 3.
|
SCB01A 12, 18 & 24 mg/m²
n=3 participants at risk
All subjects enrolled in this study would be treated from the same starting dose 12 mg/m² (Dose 1) given on Days 1 and 8 in a 21-day cycle by 24 h i.v. infusion. If the subject experiences no dose-limiting toxicity (DLT) during the period, dose escalation of SCB01A to 18 mg/m² (Dose 2) occurred from cycle 2; and increased to 24 mg/m² (Dose 3) on cycle 3.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/4 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/4 • Up to approximately 15 months (assessed continuously during treatment)
|
33.3%
1/3 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/4 • Up to approximately 15 months (assessed continuously during treatment)
|
33.3%
1/3 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
|
Gastrointestinal disorders
Chronic gastritis
|
33.3%
1/3 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/4 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
50.0%
2/4 • Number of events 2 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/4 • Up to approximately 15 months (assessed continuously during treatment)
|
33.3%
1/3 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
|
General disorders
Fatigue
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/4 • Up to approximately 15 months (assessed continuously during treatment)
|
33.3%
1/3 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
|
General disorders
Edema peripheral
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/4 • Up to approximately 15 months (assessed continuously during treatment)
|
33.3%
1/3 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
25.0%
1/4 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
25.0%
1/4 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
|
Injury, poisoning and procedural complications
Ear injury
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/4 • Up to approximately 15 months (assessed continuously during treatment)
|
33.3%
1/3 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/4 • Up to approximately 15 months (assessed continuously during treatment)
|
33.3%
1/3 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
25.0%
1/4 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/4 • Up to approximately 15 months (assessed continuously during treatment)
|
33.3%
1/3 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
33.3%
1/3 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/4 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ear neoplasm malignant
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/4 • Up to approximately 15 months (assessed continuously during treatment)
|
33.3%
1/3 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
25.0%
1/4 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
33.3%
1/3 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
25.0%
1/4 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
25.0%
1/4 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/4 • Up to approximately 15 months (assessed continuously during treatment)
|
33.3%
1/3 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
50.0%
2/4 • Number of events 2 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
25.0%
1/4 • Number of events 1 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Up to approximately 15 months (assessed continuously during treatment)
|
0.00%
0/4 • Up to approximately 15 months (assessed continuously during treatment)
|
66.7%
2/3 • Number of events 2 • Up to approximately 15 months (assessed continuously during treatment)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place