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

NCT06959082 | Recruiting Phase 2 FDA Drug

• 1 other identifier: VS-101-C3
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Head and Neck Cancer Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (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.

  6 months and 12 months

Secondary Outcomes (9)

• Objective response rate (ORR)

  6 months and 12 months

• Best overall response (BOR)

  6 months and 12 months

• Progression-free survival (PFS)

  At 6 month and 1 year

• Locoregional control (LRC)

  At 6 month and 1 year

• Distant metastasis (DM)

  through study completion, at most 1 year

Study Arms (3)

2 mg of VS-101 + CRT

EXPERIMENTAL

2 mg of VS-101 + CRT

Drug: VS-101; Drug: Cisplatin; Radiation: Radiation

5 mg of VS-101 + CRT

EXPERIMENTAL

5 mg of VS-101 + CRT

Drug: VS-101; Drug: Cisplatin; Radiation: Radiation

Only CRT

PLACEBO COMPARATOR

Only CRT

Drug: Cisplatin; Radiation: Radiation

Interventions

VS-101 DRUG

VS-101

2 mg of VS-101 + CRT; 5 mg of VS-101 + CRT

Cisplatin DRUG

Cisplatin

2 mg of VS-101 + CRT; 5 mg of VS-101 + CRT; Only CRT

Radiation RADIATION

Radiation

2 mg of VS-101 + CRT; 5 mg of VS-101 + CRT; Only CRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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: T4 (N0-N3), M0; or N3 (T1-T4), M0.
• Have measurable disease based on RECIST 1.1
• Subjects with head and neck cancer who have limited to those receiving definitive CRT without surgical excision
• Subjects prescribed standard intensity-modulated radiation therapy (IMRT) with daily fractions of 2.0 Gy to a cumulative planned dose of 70 Gy
• Subjects with Eastern Cooperative Oncology Group (ECOG) Performance Statue (PS) of 0 \~ 2
• Subjects with the status of National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 Grade 1 or lower for acute or chronic adverse reaction at the time of screening
• Subjects with an expected survival period of at least 20 weeks
• Subjects who can comply with the requirements of the clinical trial protocol
• Ability to understand and willingness to sign a written informed consent document

You may not qualify if:

• Medical History
• Patients with a history of prior radiation to the head and neck region or with a known susceptibility to radiation (e.g., genetic condition, connective tissue disease)
• Patients with suicidal behavior, major depression, or other psychiatric disorders (bipolar disorder, attention deficit hyperactivity disorder, etc.)
• Patients with neuroleptic malignant syndrome, tardive dyskinesia, elderly with dementia, uncontrolled hyperglycemia and diabetes, and patients with venous thromboembolism
• Patients with orthostatic hypotension caused by cardiovascular disease (history of myocardial infarction or ischemic heart disease, heart failure or electrocardiogram abnormality), cerebrovascular disease, or conditions prone to hypotension (dehydration, decreased blood volume, and taking antihypertensive medication)
• Patients with a history of seizures
• Patients with possible cognitive and motor performance impairments (drowsiness and sedation) (However, if the investigator determines that cognitive and motor performance impairments are not likely to be impaired, enrollment is possible.)
• Patients with conditions that may increase core body temperature (such as strenuous exercise, exposure to excessive heat, taking anticholinergic drugs, or patients prone to dehydration)
• Patients with dysphagia \[those who are taking drugs that may be affected (However, if the investigator determines that dysphagia is unlikely to occur, enrollment is possible), those with aspiration pneumonia, those with esophageal dyskinesia\]
• Patients with a history of clinically significant allergic disease (with the exception of mild allergic rhinitis that does not require treatment) or hypersensitivity to other drugs(aspirin, antibiotics, etc.)
• Subjects who show abnormalities in the following test results at the time of screening:
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 × upper limit of normal (ULN)
• Creatine clearance ≤60 mL/min (using Cockcroft-Gault (C-G) formula)
• Absolute neutrophil count (ANC) \<1,500/µL
• Platelets \<100,000/µL

Sponsors & Collaborators

• VSPharmTech Co.,Ltd.: lead

Study Sites (3)

Yale Cancer Center

New Haven, Connecticut, 06510, United States

RECRUITING

Cancer Center of Kansas

Wichita, Kansas, 67214, United States

RECRUITING

NYU Langone Health

Manhattan, New York, 10016, United States

RECRUITING

MeSH Terms

Interventions

Cisplatin; Radiation

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 6, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

US (3)