A Study of PEP503 With Radiotherapy in Combination With Concurrent Chemotherapy for Patients With Head and Neck Cancer

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

It's a prospective, open-label, single arm, nonrandomized study of PEP503 in head and neck squamous cell carcinoma (HNSCC) patients.

• Escalation portion (Phase 1b):A 3 + 3 dose escalation study design will be adopted in this phase to identify the recommended intratumor injection volumes of PEP503.

• Expansion portion (Phase 2): Following confirmation of the recommended volumes, 18 additional patients will be enrolled at the recommended volume level to evaluate for safety and efficacy.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PharmaEngine
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed squamous cell carcinoma (SCC) of oral cavity, oropharynx, hypopharynx, or larynx

• Locally advanced or recurrent disease of: Oral Cavity:T4b, N any, who are not candidates for surgical resection; or T3-4, N any, who decline surgery or medical inoperable; OR Oropharynx, hypopharynx, or larynx: T3-4, N any

• No evidence of distant metastatic disease, as determined by a negative PET scan or CT scan

• ECOG Performance Status 0 or 1

• Adequate function of bone marrow, kidney and liver:

• White Blood Cell (WBC) ≥ 3.0 x 109/l

• Absolute neutrophil count (ANC) ≥ 1.5 x 109/l

• Platelet count ≥ 100 x 109/l

• Hemoglobin ≥ 9.0 g/dL

• Creatinine within normal range, for dose level with tri-weekly cisplatin, estimated GFR ≥ 60 mL/min/1.73m2 or CrCl ≥ mL/min is also required

• AST ≤ 2.5 x ULN, ALT ≤ 2.5 x ULN and Alkaline phosphatase (ALP) ≤ 2.5 x ULN

• Bilirubin ≤ 1.5 x ULN

• 20 years of age or older

• All female patients of childbearing potential must have negative urine pregnancy test within 7 days prior to study treatment with PEP503. Fertile patients must agree to use effective contraception during the study

Exclusion Criteria:

• Tumor ulceration combined with vascular risks

• Prior radiotherapy to any area within the planned radiotherapy field

• Uncontrolled intercurrent illness

• Concurrent treatment with any other anticancer therapy

• Participation in any investigational drug study within 4 weeks

• Prior or concurrent non-head and neck malignancies, excluding adequately treated basal or squamous cell cancer of the skin, and in situ cervical cancer, and any other cancer from which the subject has been cancer free for 5 years

• Patients unable to comply with scheduled visits and other study procedures.

• Preexisting neuropathy ≥ Grade 2 (CTCAE)

• Pre-existing hearing impairment > Grade 2 (CTCAE) for patients receiving cisplatin 100 mg/m2

• History of allergic reaction to platinum product