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: 2

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)

• 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.

  6 months and 12 months

Secondary Outcomes (9)

• Disease control rate (DCR)

  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: Stage III per TNM guidelines
• 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

You may not qualify if:

• 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:
• 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)

Sponsors & Collaborators

• VSPharmTech Co.,Ltd.: lead

Study Sites (2)

Yale Cancer Center

New Haven, Connecticut, 06510, 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: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

US (2)