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Head and Neck Cancer Squamous Cell CarcinomaPhase 2NCT06959082

Efficacy and Safety Evaluation of VS-101 in Combination With Chemoradiotherapy in Patients With Head and Neck Cancer

A Phase 2 study testing VS-101, Cisplatin and Radiation in people with Head and Neck Cancer Squamous Cell Carcinoma, run by VSPharmTech Co.,Ltd. at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This will be a multi-center, randomized, open-label, parallel-group study in adult patients with head and neck cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
VS-101, Cisplatin and Radiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
2 sitesUnited States
Study dates
11 Jun 2025to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or females aged more than 18 years at the time of ICF signing
  • Diagnosed based on position emission tomography (PET), computed tomography (CT), or magnetic resonance imaging (MRI) with pathologically confirmed (histologic or cytological) head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
  • Defined by American Joint Committee on Cancer [AJCC] Guidelines 8th Edition:
  • Oral cavity, hypopharynx, or larynx (independent of p16): Stage III, IVa, IVb per TNM guidelines; or
  • Oropharyngeal p16 negative disease: Stage III, IVa, IVb per TNM guidelines; or
  • Oropharyngeal p16 positive disease: Stage III per TNM guidelines
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  • Have measurable disease based on RECIST 1.1
  • Participants with head and neck cancer who have limited to those receiving definitive CRT without surgical excision
  • Participants prescribed standard intensity-modulated radiation therapy (IMRT) with a cumulative planned dose of approximately 70 Gy
  • Participants with Eastern Cooperative Oncology Group (ECOG) Performance Statue (PS) of 0 ~ 2
  • Participants with the status of National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0 Grade 2 if stable and not clinically significant, or lower for acute or chronic adverse reaction at the time of screening
  • Participants with an expected survival period of at least 20 weeks
  • Participants who can comply with the requirements of the clinical trial protocol
  • Ability to understand and willingness to sign a written informed consent document

Who cannot join

  • Medical History
  • Patients with a history of prior radiation to the head and neck region which overlap with the planned radiation fields (or cumulative doses exceed the constraints for organs-at-risk [OAR]) or with a known susceptibility to radiation.
  • Patients with active or uncontrolled or clinically significant medical or psychiatric disorders that, in the investigator's opinion, may interfere with informed consent, adherence, or patient safety. Stable medical or psychiatric conditions under a stable dose regimen are permitted.
  • Patients with a history of uncontrolled seizure disorder. Patients with a remote history of a single provoked seizure or well-controlled seizures on stable monotherapy may be eligible.
  • Patients who are unable to swallow the study tablet at the screening visit, unless a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube is already in place for clinically indicated reasons and the patient is clinically stable.
  • Patients who show abnormalities in the following test results at the time of screening:
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  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 × upper limit of normal (ULN)
  • Creatine clearance ≤50 mL/min (using Cockcroft-Gault (C-G) formula)
  • Absolute neutrophil count (ANC) <1,500/µL
  • Platelets <100,000/µL
  • Hemoglobin <9 g/dL
  • Serum calcium >1.5 × ULN
  • Total bilirubin > 2 × ULN
  • Prothrombin time (PT) (International Normalized Ratio [INR]) >1.5 × ULN or activated partial thromboplastin time (aPTT) (sec)
  • Positive result for serum tests (hepatitis B or C virus, human immunodeficiency virus [HIV], rapid plasma reagin [RPR] test)
  • Patients who show significant abnormalities in electrocardiogram (ECG) test results (e.g.,QTcF > 450 msec)
  • Patients who received hypofractionated chemoradiation regimens (> 2 Gy per day) Note：If it is established that the abnormal lab values are a consequence of their underlying malignant disease rather than any other co-existing condition, reflect minor variations attributable to individual differences or testing conditions, and is not considered clinically significant, the Principal Investigator (PI) may discuss the case with the Medical Monitor to determine eligibility.
  • Patients with known hypersensitivity to components or excipients of clinical investigational drugs
  • Participants with a history of drug addiction within 3 months before ICF signing, unless a Urine drug screen negative result is obtained prior to randomization
  • Contraindicated Drugs and Treatments:
  • Participants who have administered strong cytochrome P450 (CYP) 3A4 or CYP2D6 inducers or inhibitors within 14 days of baseline or 5 times the drug's half-life, whichever is longer.
  • Participants who received chemotherapy within 14 days of baseline (drugs or treatment known to have anticancer effects such as cytotoxic chemotherapy, antihormonal therapy, and targeted therapy).
  • Participants who required intravenous antibiotics, antivirals, or antifungals for active or uncontrolled infection at baseline.
  • Participants who have administered benzodiazepines (e.g., lorazepam) that causes clinically significant sedation (stable low dose is permitted).
  • Participants who participated in another clinical trial within 4 weeks of the baseline and administered the clinical trial drug
  • Participants and their spouses (or partners) with childbearing potential who are not using medically acceptable methods of contraception for the duration of the trial and for 14 months (in female participants) and 11 months (in male participants) after the last dose of cisplatin treatment
  • Participants who, in the judgment of other investigators, are not suitable to participate in the study"

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites, 2 recruiting

  • NYU Langone Health

    Manhattan, New York, 10016

    CRM, +82 1099171335, ynmoon@vspharmtech.com

    Recruiting

  • Yale Cancer Center

    New Haven, Connecticut, 06510

    Clinical Research Coordinator, 203-228-2385, anna.wu@yale.edu

    Recruiting

Other trials in United States

About this study

Official title: A Multi-center, Randomized, Open-label, Parallel-group, Phase 2 Study to Evaluate the Efficacy and Safety of VS-101 in Combination With Chemoradiotherapy (CRT) in Patients With Head and Neck Cancer

This will be a multi-center, randomized, open-label, parallel-group study in adult patients with head and neck cancer.

Being tested
VS-101, Cisplatin, Radiation

What participants receive

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

Study groups in NCT06959082
Study groupRoleWhat they receive
2 mg of VS-101 + CRTExperimental2 mg of VS-101 + CRT
Receives: Drug: VS-101; Drug: Cisplatin; Radiation: Radiation
5 mg of VS-101 + CRTExperimental5 mg of VS-101 + CRT
Receives: Drug: VS-101; Drug: Cisplatin; Radiation: Radiation
Only CRTPlacebo comparatorOnly CRT
Receives: Drug: Cisplatin; Radiation: Radiation

What is being measured

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

  1. Objective response rate (ORR)

    The proportion of participants who achieve an ORR at 6 months and 12 months will be summarized with the 95% confidence interval on the mITT and PP samples.

    Measured: 6 months and 12 months

Secondary outcomes (9)

  1. Disease control rate (DCR)

    proportion of subjects who have a complete response (CR), partial response (PR), or stable disease (SD) at 6 months and 12 months will be summarized with the 95% confidence interval on the mITT and PP samples.

    Measured: 6 months and 12 months

  2. Best overall response (BOR)

    The BOR will be based on all post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy. BOR will be summarized for the following categories: CR, PR, SD, PD and non-evaluable.

    Measured: 6 months and 12 months

  3. Progression-free survival (PFS)

    The PFS will be analyzed using Kaplan-Meier methods on the mITT and PP samples. KM estimates and associated two-sided 95% confidence intervals will be presented for each cohort. Participants who have no documented progression and are still alive at the time of analysis will be censored at the time of the latest date of assessment.

    Measured: At 6 month and 1 year

  4. Locoregional control (LRC)

    Rate of Locoregional recurrence after end of treatment (FDG-PET/CT scan).

    Measured: At 6 month and 1 year

  5. Distant metastasis (DM)

    The proportion of participants who develop DM will be summarized with the 95% confidence interval on the mITT and PP samples

    Measured: through study completion, at most 1 year

  6. Overall survival (OS)

    The OS will be analyzed using Kaplan-Meier methods on the mITT and PP samples. KM estimates and associated two-sided 95% confidence intervals will be presented for each cohort, and 1-year survival estimate will be calculated

    Measured: 1 year

  7. Changes in tumor size

    Tumor imaging (CT and MRI) will be performed.

    Measured: through study completion, at most 1 year

  8. Number and severity of treatment-emergent adverse events (TEAEs), treatment-related AEs, and serious adverse events (SAEs) for all dose groups according to the NCICTCAE version 5.0

    AE will be measured by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

    Measured: through study completion, at most of 1 year

  9. Health-related quality of life (HR-QoL)

    FACT-H\&N V4.

    • Physical Well-Being
    • Social/Familiy Well-Being
    • Emotional Well-Being
    • Functinal Well-Being

    Measured: at week1, week8, week11, week 19, week 27 and week 52

Timeline

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

  1. First posted6 May 2025
  2. Study start11 Jun 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06959082
Sponsor's protocol ID
VS-101-C3
Status last verified
Sep 2026
First submitted
16 Apr 2025
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VS-101, Cisplatin and Radiation in people with Head and Neck Cancer Squamous Cell Carcinoma, run by VSPharmTech Co.,Ltd. at 2 sites in United States.

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 14 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: 6 months and 12 months). 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 NCT06959082.

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 2 Sep 2026.

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