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).

SCB01A 24 mg/m²

Overall Study

This is an open-label, single-arm, dose-escalation, safety and tolerability study. Eligible subjects will be assigned to a SCB01A dose level at the time of study entry and scheduled to receive two treatment cycles with SCB01A for the observation of DLT. A treatment cycle is defined as a three-hour infusion of SCB01A given every 21 days. Unless any off-study criteria are met, the study period of each subject can be up to two cycles.

Muh-Hwan Su, Ph.D.

The goal of this study with SCB01A is to determine the Maximum Tolerated Dose of SCB01A in patients with advanced solid tumors that have failed previous therapy.

A Dose Escalation Study of SCB01A in Subjects With Advanced Solid Tumors Who Have Failed Standard Therapy

A Phase 1 Dose Escalation Study of SCB01A in Subjects With Advanced Solid Tumors Who Have Failed Standard Therapy

MTD is the dose at which at least two subjects experience the DLT; and DLT is defined as Grade 3 or greater Neutropenia, Thrombocytopenia, prolonged QTc, non-hematological adverse events and neurotoxicity

DLT is defined as Grade 3 or greater Neutropenia, Thrombocytopenia, prolonged QTc, non-hematological adverse events and neurotoxicity

This is a companion study to the protocol SCB01A-01 intended to provide long-term continued administration to subjects that completed Protocol SCB01A-01 on a compassionate basis. It is an open-label, single-arm study of SCB01A in subjects who have completed 2 cycles of treatment under the SCB01A-01 protocol.

The primary objective is to characterize the safety profile of long-term exposure to SCB01A when administered to cancer subjects with advanced solid tumors. Furthermore, the efficacy profile will also be explored in this study.

This is a companion study to the protocol SCB01A-01 intended to provide long-term continued administration to subjects that completed Protocol SCB01A-01 on a compassionate basis. It is an open-label, single-arm study of SCB01A in subjects who have completed at least one cycles of treatment under the SCB01A-01 protocol.

Long-Term Compassionate Use Study for Continued Administration of SCB01A-01

Long-Term Compassionate Use Study for Continued Administration of SCB01A In Subjects Who Completed Treatment With SCB01A in the Previous Protocol # SCB01A-01

Other Dietary Supplements

All Drugs and Chemicals

Indole

intra-subject dose escalation starting from 12 mg/m2, then to18 mg/m2, and finally to 24 mg/m2 if no DLT

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.

Her-Shyong Shiah, MD

The aim of this study is to evaluate the efficacy and safety of i.v. infusion for 24-hour of SCB01A in subjects with squamous cell carcinoma of head and neck who have failed previous platinum based therapies.

From pre-clinical pharmacology and phase I clinical study SCB01A has demonstrated promising anticancer action with a vascular disrupting activity that has the potential for treatment of various malignancies, particularly for patients with drug resistance. The drug has been studied in human subjects in a dose escalation phase I study and has shown to be safe for up to 2 cycles of 24 mg/m2 (each cycle consisting of one intravenous \[i.v.\] administration of SCB01A via a central line every 3 weeks). In the phase I study, partial response (PR) (shrinkage of tumor size to 50%) was observed in cycle 9 (3 mg/m2) of one subject with right buccal squamous cell carcinoma and 19/33 (58%) subjects had stable disease (SD) for more than 2 cycles.

Pre clinical study of SCB01A showed that the concentrations at which tubulin inhibition occurred were around 80 nM for 24-hour exposure or 200 nM for 6-hour exposure. However, pharmacokinetic (PK) results of phase I study showed that the average elimination half-life (t1/2) of a 3-hours i.v. infusion of SCB01A is approximately 2.5 hours and almost no SCB01A can be detected after 10 hours, indicating most subjects were treated in short API exposure time and may have been insufficient to achieve efficacy. Therefore, to extend the exposure duration above effective concentration in blood may increase the treatment efficacy.

The aim of this study is to evaluate the efficacy and safety of i.v. infusion for 24-hour of SCB01A in subjects with squamous cell carcinoma of head and neck who have failed previous platinum based therapies.

To Evaluate the Efficacy and Safety of SCB01A in Subjects With r/m Squamous Cell Head and Neck Cancer

An Open-Label, Phase II Study to Evaluate the Efficacy and Safety of SCB01A in Subjects With Recurrent or Metastatic Squamous Cell Head and Neck Cancer Who Have Failed Platinum-Based 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.

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).

OS is defined as the as the time from the start of treatment up to the time that the subject is still alive.

Best overall tumor response is defined as an objective response or stable disease of treatment phase.

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 mg/m² Only

SCB01A 12 & 18 mg/m²

SCB01A 12, 18 & 24 mg/m²

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.

SCB01A Alone

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

ECOG 1: Symptoms, but ambulatory. Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of SCB01A in Patient With Head and Neck Cancer	NCT02488629	Head and Neck S...	SCB01A	20 Years -	SynCore Biotechnology Co., Ltd.
Study of SCB01A in Patient With Head and Neck Cancer	NCT02488629	Head and Neck S...	SCB01A	20 Years -	SynCore Biotechnology Co., Ltd.
A Dose Escalation Study of SCB01A in Subjects With Advanced Solid Tumors Who Have Failed Standard Therapy	NCT01159522	Solid Tumors	SCB01A	18 Years -	SynCore Biotechnology Co., Ltd.
Long-Term Compassionate Use Study for Continued Administration of SCB01A-01	NCT01151930	Malignant Solid...	SCB01A	18 Years -	SynCore Biotechnology Co., Ltd.
A Dose Escalation Study of SCB01A in Subjects With Advanced Solid Tumors Who Have Failed Standard Therapy	NCT01159522	Solid Tumors	SCB01A	18 Years -	SynCore Biotechnology Co., Ltd.
Long-Term Compassionate Use Study for Continued Administration of SCB01A-01	NCT01151930	Malignant Solid...	SCB01A	18 Years -	SynCore Biotechnology Co., Ltd.
To Evaluate the Efficacy and Safety of SCB01A in Subjects With r/m Squamous Cell Head and Neck Cancer	NCT03020823	Head and Neck N...	SCB01A	20 Years -	SynCore Biotechnology Co., Ltd.

Spots Global Cancer Trial Database for scb01a

Every month we try and update this database with for scb01a cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for scb01a

Every month we try and update this database with for scb01a cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for scb01a cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.