Trial Outcomes & Findings for Study of SCB01A in Patient With Head and Neck Cancer (NCT NCT02488629)

Last Updated: 2023-06-27

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

9 weeks from 1st administrationm drug

Results posted on

2023-06-27

Participant Flow

No subjects were enrolled in Run-in Phase I: Dose 3 (18 mg/m²), Dose 4 (24 mg/m²), and Phase II.

Participant milestones

Participant milestones
Measure	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).	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).
Overall Study STARTED	3	2
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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).	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).	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).	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).
Overall Study Lack of Efficacy	3	1	0	0
Overall Study Withdrawal by Subject	0	1	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Run-in Phase I (Dose Escalation Phase): 3.25 mg/m² (Dose 1) n=3 Participants 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.	Run-in Phase I (Dose Escalation Phase): 12 mg/m² (Dose 2) n=2 Participants 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 n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=3 Participants	2 Participants n=2 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=5 Participants
Age, Continuous	56.3 years n=3 Participants	53.5 years n=2 Participants	55.2 years n=5 Participants
Sex: Female, Male Female	0 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=3 Participants	2 Participants n=2 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=3 Participants	2 Participants n=2 Participants	5 Participants n=5 Participants
Region of Enrollment Taiwan	3 Participants n=3 Participants	2 Participants n=2 Participants	5 Participants n=5 Participants
ECOG at Screening visit 0	0 Participants n=3 Participants • Data not collected for 12 mg/m² (Dose 2) cohort as the 2 subjects from the Dose 2 did not complete 3 treatment cycles.	—	0 Participants n=3 Participants • 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 1	2 Participants n=3 Participants • Data not collected for 12 mg/m² (Dose 2) cohort as the 2 subjects from the Dose 2 did not complete 3 treatment cycles.	—	2 Participants n=3 Participants • 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 2	1 Participants n=3 Participants • Data not collected for 12 mg/m² (Dose 2) cohort as the 2 subjects from the Dose 2 did not complete 3 treatment cycles.	—	1 Participants n=3 Participants • Data not collected for 12 mg/m² (Dose 2) cohort as the 2 subjects from the Dose 2 did not complete 3 treatment cycles.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Run-in Phase I (Dose Escalation Phase): 3.25 mg/m² (Dose 1) n=3 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).
Disease Control Rate (DCR) Complete Response (CR)	0 Participants
Disease Control Rate (DCR) Partial Response (PR)	0 Participants
Disease Control Rate (DCR) Stable Disease (SD)	1 Participants
Disease Control Rate (DCR) Progressive Disease (PD)	2 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Run-in Phase I (Dose Escalation Phase): 3.25 mg/m² (Dose 1) n=3 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).
To Assess the Overall Survival Rate	25.57 weeks Interval 10.14 to 32.14

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Run-in Phase I (Dose Escalation Phase): 3.25 mg/m² (Dose 1) n=3 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).
To Assess the Progression-free Survival According to RECIST v.1.1	8.71 weeks Interval 8.43 to 12.14

Adverse Events

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

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

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

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Run-in Phase I (Dose Escalation Phase): 3.25 mg/m² (Dose 1) n=3 participants at risk 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): 12 mg/m² (Dose 2) n=2 participants at risk 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).
Vascular disorders Hypotension	33.3% 1/3 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment	0.00% 0/2 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Investigations Weight decreased	33.3% 1/3 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment	0.00% 0/2 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/3 • From the time of informed consent obtained until 28 days after the last dose of study treatment	50.0% 1/2 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment

Other adverse events

Additional Information

Dr. Lin

Syncore

Phone: 0227603688

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Run-in Phase I (Dose Escalation Phase): 3.25 mg/m² (Dose 1) n=3 participants at risk 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): 12 mg/m² (Dose 2) n=2 participants at risk 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).
General disorders Facial pain	33.3% 1/3 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment	0.00% 0/2 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Injury, poisoning and procedural complications Procedural pain	33.3% 1/3 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment	0.00% 0/2 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Metabolism and nutrition disorders Decreased appetite	66.7% 2/3 • Number of events 2 • From the time of informed consent obtained until 28 days after the last dose of study treatment	0.00% 0/2 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Respiratory, thoracic and mediastinal disorders Haemoptysis	33.3% 1/3 • Number of events 2 • From the time of informed consent obtained until 28 days after the last dose of study treatment	50.0% 1/2 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Blood and lymphatic system disorders Anaemia	66.7% 2/3 • Number of events 2 • From the time of informed consent obtained until 28 days after the last dose of study treatment	0.00% 0/2 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Metabolism and nutrition disorders Hypokalaemia	33.3% 1/3 • Number of events 2 • From the time of informed consent obtained until 28 days after the last dose of study treatment	0.00% 0/2 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment	0.00% 0/2 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Investigations Weight decreased	33.3% 1/3 • Number of events 2 • From the time of informed consent obtained until 28 days after the last dose of study treatment	50.0% 1/2 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	33.3% 1/3 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment	0.00% 0/2 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Blood and lymphatic system disorders Leukocytosis	33.3% 1/3 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment	0.00% 0/2 • From the time of informed consent obtained until 28 days after the last dose of study treatment
General disorders Pyrexia	33.3% 1/3 • Number of events 3 • From the time of informed consent obtained until 28 days after the last dose of study treatment	0.00% 0/2 • From the time of informed consent obtained until 28 days after the last dose of study treatment
General disorders Feeling cold	33.3% 1/3 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment	0.00% 0/2 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Psychiatric disorders Insomnia	33.3% 1/3 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment	0.00% 0/2 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Psychiatric disorders Anxiety	33.3% 1/3 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment	0.00% 0/2 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Infections and infestations Periodontitis	33.3% 1/3 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment	0.00% 0/2 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Psychiatric disorders Delirium	33.3% 1/3 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment	0.00% 0/2 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment	50.0% 1/2 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Vascular disorders Hypertension	33.3% 1/3 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment	0.00% 0/2 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment	50.0% 1/2 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Nervous system disorders Dizziness	33.3% 1/3 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment	0.00% 0/2 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Skin and subcutaneous tissue disorders Swelling face	33.3% 1/3 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment	0.00% 0/2 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Skin and subcutaneous tissue disorders Pruritus	33.3% 1/3 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment	0.00% 0/2 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	33.3% 1/3 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment	0.00% 0/2 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Infections and infestations Tinea manuum	0.00% 0/3 • From the time of informed consent obtained until 28 days after the last dose of study treatment	50.0% 1/2 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Infections and infestations Conjunctivitis	0.00% 0/3 • From the time of informed consent obtained until 28 days after the last dose of study treatment	50.0% 1/2 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Gastrointestinal disorders Mouth ulceration	0.00% 0/3 • From the time of informed consent obtained until 28 days after the last dose of study treatment	50.0% 1/2 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/3 • From the time of informed consent obtained until 28 days after the last dose of study treatment	50.0% 1/2 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Gastrointestinal disorders Dry mouth	0.00% 0/3 • From the time of informed consent obtained until 28 days after the last dose of study treatment	50.0% 1/2 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • From the time of informed consent obtained until 28 days after the last dose of study treatment	50.0% 1/2 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment
General disorders Fatigue	0.00% 0/3 • From the time of informed consent obtained until 28 days after the last dose of study treatment	50.0% 1/2 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Gastrointestinal disorders Salivary gland pain	0.00% 0/3 • From the time of informed consent obtained until 28 days after the last dose of study treatment	50.0% 1/2 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Infections and infestations Sialoadenitis	0.00% 0/3 • From the time of informed consent obtained until 28 days after the last dose of study treatment	50.0% 1/2 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • From the time of informed consent obtained until 28 days after the last dose of study treatment	50.0% 1/2 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/3 • From the time of informed consent obtained until 28 days after the last dose of study treatment	50.0% 1/2 • Number of events 1 • From the time of informed consent obtained until 28 days after the last dose of study treatment