Head and Neck Squamous Cell CarcinomaPhase 2NCT02488629

Study of SCB01A in Patient With Head and Neck Cancer

A Phase 2 study testing SCB01A in people with Head and Neck Squamous Cell Carcinoma, run by SynCore Biotechnology Co., Ltd. at 5 sites in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

To evaluate the safety and efficacy of SCB01A in head and neck cancer. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Head and Neck Squamous Cell Carcinoma
What is being tested?: SCB01A
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 5 sitesTaiwan
Study dates: Sep 2015to Dec 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Confirmed squamous cell carcinoma of head and neck
Patients with nonresectable, unfeasible radiotherapy, recurrent or metastatic carcinoma, after previous treatment with platinum agent.
At least one measurable tumor lesion according to RECIST
Suitable Eastern Cooperative Oncology Group (ECOG) performance status
All eligible patients of childbearing potential have to use effective contraception
Signed informed consent before enrolment

Who cannot join

Receiving Chemotherapy, radiation therapy, major surgery or investigational agents
Severe pulmonary obstructive or restrictive disease
Uncontrolled inflammatory disease
Clinically significant cardiac disease
Results of laboratory tests
Pregnancy or nursing status

Show all 11Show fewer

Known hypersensitivity to any component of SCB01A
History of exposure to SCB01A or its analogues
History of malignancy other than head and neck cancer
History of active or significant neurological disorder or psychiatric disorder
Any other reason the investigator deems the patient to be unsuitable for the study

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Taiwan5 sites

Keelung Chang Gung Memorial Hospital & lovers lake branch
Keelung
National Cheng Kung University Hospital
Tainan
MacKay Memorial Hospital
Taipei
National Taiwan University Hospital
Taipei
Linkou Chang Gung Memorial Hospital
Taoyuan

Other trials in Taiwan

About this study

Official title: 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 evaluate the safety and efficacy of SCB01A in head and neck cancer.

Read the 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.

Conditions: Head and Neck Squamous Cell Carcinoma
Being tested: SCB01A
Keywords: Head and neck squamous cell carcinoma
Medical subject headings: Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SCB01ADrug
This study is a single arm, open-label, Phase II trial

Study groups in NCT02488629
Study group	Role	What they receive
SCB01A	Experimental	This study is a single arm, open-label, Phase II trial Receives: Drug: SCB01A

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 9 weeks from 1st administrationm drug

Secondary outcomes (2)

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.
Measured: an expected average of 36 weeks
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).
Measured: an expected average of 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2015Dec 2017

First posted2 Jul 2015 (estimated)
Study startSep 2015
Primary completionDec 2017
Study completionDec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02488629
Sponsor's protocol ID: SCB01A-21
Status last verified: Jun 2023
First submitted: 29 Jun 2015
Last updated: 27 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Tumoral Versus Luminal Microbiome in Head and Neck Squamous Cell Carcinoma
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All Head and Neck Squamous Cell Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02488629
Acronym / sponsor ID: SCB01A-21
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: Head and neck squamous cell carcinoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 5 participants (actual)
Lead sponsor: SynCore Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
Study start: Sep 2015
Primary completion: Dec 2017 (actual)
Study completion: Dec 2017 (actual)
First posted: 2 Jul 2015 (estimated)
Results: Posted 27 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
SCB01A	Experimental	Drug: SCB01AThis study is a single arm, open-label, Phase II trial

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Confirmed squamous cell carcinoma of head and neck
Patients with nonresectable, unfeasible radiotherapy, recurrent or metastatic carcinoma, after previous treatment with platinum agent.
At least one measurable tumor lesion according to RECIST
Suitable Eastern Cooperative Oncology Group (ECOG) performance status
All eligible patients of childbearing potential have to use effective contraception

Key exclusion criteria (11 listed)

Receiving Chemotherapy, radiation therapy, major surgery or investigational agents
Severe pulmonary obstructive or restrictive disease
Uncontrolled inflammatory disease
Clinically significant cardiac disease
Results of laboratory tests

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SCB01AThis study is a single arm, open-label, Phase II trial	Drug	SCB01A

Primary outcome

Disease Control Rate (DCR)
Time frame: 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.

2 secondary outcomes

To Assess the Overall Survival Rate
Time frame: an expected average of 36 weeks
To Assess the Progression-free Survival According to RECIST v.1.1
Time frame: an expected average of 12 weeks

Results and safety

Results posted to the registry on 27 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SCB01A 3.25 mg/m²	3	0
SCB01A 12 mg/m²	2	0
SCB01A 18 mg/m²	0	0
SCB01A 24 mg/m²	0	0

Primary outcome: Disease Control Rate (DCR)

Time frame: 9 weeks from 1st administrationm drug. Count of participants. Unit: Participants

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

Population analysed: 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 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the time of informed consent obtained until 28 days after the last dose of study treatment. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Run-in Phase I (Dose Escalation Phase): 3.25 mg/m² (Dose 1)	1 of 3 (33.3%)	3 of 3 (100%)	1 of 3
Run-in Phase I (Dose Escalation Phase): 12 mg/m² (Dose 2)	1 of 2 (50%)	2 of 2 (100%)	1 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Head and Neck Squamous Cell Carcinoma

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
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RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hui-Hung Wang, MSc study director

SynCore Biotechnology Co., Ltd.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SCB01A in people with Head and Neck Squamous Cell Carcinoma, run by SynCore Biotechnology Co., Ltd. at 5 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Control Rate (DCR) (time frame: 9 weeks from 1st administrationm drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02488629.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.