Study to Evaluate the Efficacy and Safety of Three Different Doses of SCV 07 in Attenuating Oral Mucositis in Subjects With Head and Neck Cancer

A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Three Different Doses of SCV 07 in Attenuating Oral Mucositis in Subjects With Head and Neck Cancer Receiving Concurrent Chemotherapy and Radiotherapy

This is a phase 2b, double-blind, placebo-controlled, 4-arm, adaptive-design trial, initially stratified by cisplatin regimen, and then randomized 1:1:1:1. The study will be conducted in subjects receiving ChemoRT for the treatment of squamous cell carcinomas (SCCs) of the oral cavity, oropharynx, hypopharynx, or larynx. The study includes a treatment period of approximately 7 weeks, depending on the subject's prescribed radiation plan, and Week 1 and Week 4 post RT follow-up visits. It also includes a longer follow-up period of approximately 12 months to determine if there is an effect of SCV 07 on the tumor response to ChemoRT.

Inclusion Criteria:

• Willing and able to understand and sign an informed consent form (ICF) for the study approved by the Investigator's local or a central Institutional Review Board (IRB)

• Have recently diagnosed, pathologically confirmed, non-metastatic SCC of the oral cavity, oropharynx, hypopharynx, or larynx that will be treated with ChemoRT as first-line treatment; subjects with a history of surgical management are eligible

• Have a plan to receive a continuous course of conventional external beam irradiation delivered by intensity-modulated radiotherapy (IMRT) as single daily fractions of 2.0 to 2.2 Gy, with a cumulative radiation dose between 50 and 72 Gy. Planned radiation treatment fields must include at least 2 oral sites (buccal mucosa, floor of oral cavity, tongue, or soft palate), with each site receiving ≥ 50 Gy

• Have a plan to receive a standard cisplatin CT regimen administered tri-weekly (80 to 100 mg/m2, on Days 0, 21, and 42) or weekly (30 to 40 mg/m2)

• Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

• Have adequate hematopoietic, hepatic, and renal function at the screening visit:

  • Hematopoietic function

    • Hemoglobin ≥ 10 g/dL
    • Absolute neutrophil counts (ANC) ≥ 1,500 cells/mm3
    • Platelet count ≥ 100 × 109/L

  • Hepatic function

    • Total bilirubin < 1.5 times the upper-normal limit (ULN)
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 times the ULN

  • Renal function: Serum creatinine concentration ≤ 2 mg/dL; if result is ≥ 1.4 mg/dL and ≤ 2.0 mg/dL, a 24-hour urinary creatinine clearance test must be performed by the site's local laboratory. To be eligible for the study, a subject must demonstrate a 24-hour urinary creatinine clearance ≥ 50 mL/min

• Have a negative serum pregnancy test if a woman is of childbearing potential

• Agree to use medically acceptable methods of birth control during study participation and for 30 days following the last CTM treatment if a woman is of childbearing potential

• Males or females aged 18 years or older.

Exclusion Criteria:

• Tumor of the lips, sinuses, salivary glands, nasopharynx, or unknown primary tumor
• Metastatic disease (M1) Stage IV C
• Prior radiation to the head and neck
• Plan to be treated with cetuximab (Erbitux®)
• Have undergone induction CT
• History of other malignant tumors, excluding non-melanoma skin cancer or curatively excised in situ cervical carcinoma
• Have had a major surgical procedure, other than for HNC, or significant traumatic injury within 4 weeks prior to the initiation of RT; anticipation of need for a major surgical procedure during the study
• Active infectious disease, excluding oral candidiasis
• Have OM at the baseline visit
• Have a diagnosis of autoimmune disease requiring chronic immunosuppression
• Known seropositivity for HIV, HBV, or HCV
• Prior use of SCV 07
• Have used any investigational agent within 30 days of randomization
• Are pregnant or breastfeeding
• Known allergies or intolerance to cisplatin
• Unable to give informed consent or comply with study requirements, including completing the subject diary and QOL instruments
• Have any other condition or therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with follow-up visits.