Clinical Trials List
Protocol NumberPEP503-HN-1002
2015-12-01 - 2021-05-20
Phase I/II
Recruiting3
Terminated1
ICD-10C47.0
Malignant neoplasm of peripheral nerves of head, face and neck
ICD-10C49.0
Malignant neoplasm of connective and soft tissue of head, face and neck
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9171.0
Malignant neoplasm of connective and other soft tissue of head, face and neck
A Phase 1b/2 Study of PEP503 (Radioenhancer) with Radiotherapy in Combination with Concurrent Chemotherapy for Patients with Head and Neck Cancer
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Trial Applicant
PharmaEngine Inc.
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Sponsor
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Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ming-Yu Lien Division of Hematology & Oncology
- Yao-Ching Wang Division of Radiation Therapy
- Ming-Hsui Tsai Division of Otolaryngology
- 詹日全 Division of Otolaryngology
- Ti-Hao Wang Division of Radiation Therapy
- Ching Yun Hsieh Division of Hematology & Oncology
- Ying-Chun Lin Division of Radiation Therapy
- Chun-Hung Hua Division of Otolaryngology
- Shih-Neng Yang Division of Radiation Therapy
The Actual Total Number of Participants Enrolled
1 Recruiting
Co-Principal Investigator
- YA-FANG CHEN Division of Radiology
- 陳俊男 Division of Otolaryngology
- 王駿瑋 Division of Radiation Therapy
- Tsung-Lin Yang Division of Otolaryngology
- HUAI-CHENG HUANG Division of Hematology & Oncology
- 賴詩璠 Division of Radiation Therapy
- 陳贈成 Division of Otolaryngology
- 廖斌志 Division of Hematology & Oncology
- 蔡巧琳 Division of Radiation Therapy
- 王成平 Division of Otolaryngology
- 林玫君 Division of Otolaryngology
- 陳婉瑜 Division of Radiation Therapy
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Head and Neck Cancer
Objectives
Primary Objectives:Phase 1b (dose escalation portion)- To assess the safety profile and determine the Dose Limiting Toxicity (DLT) of PEP503 given as intratumor injection and activated by external beam radiation in combination with chemotherapy in patients with advanced or recurrent head and neck cancer.- To define the recommended volumes (doses) of PEP503 given as intratumor injection to the tumor and activated by external beam radiation in combination with chemotherapy in patients with advanced or recurrent head and neck cancer.Phase 2 (expansion portion)- To evaluate the anti-tumor activity in terms of the rate of locoregional control at one year of PEP503 given as intratumor injection and activated by external beam radiation in combination with concurrent chemotherapy in patients with advanced or recurrent head and neck cancer.- To evaluate the safety profile of PEP503 given as intratumor injection and activated by external bean radiation in combination with concurrent chemotherapy in patients with advanced or recurrent head and neck cancer.Secondary Objectives:Phase 1b (dose escalation portion)- To characterize the body kinetic profile of PEP503 after intratumor injection.Phase 2 (expansion portion)- To evaluate the anti-tumor activity of PEP503 given as intratumor injection and activated by external beam radiation in combination with concurrent chemotherapy in patients with advanced or recurrent head and neck cancer in terms of: objective tumor response (as per RECIST 1.1) progression free survival rate at 1 year pathological response (pR)
Test Drug
PEP503
Active Ingredient
Hafnium oxide nanoparticle
Dosage Form
Solution
Dosage
64
Endpoints
Safety evaluations:
physical examination, vital signs, ECG, body weight, Eastern Cooperative Oncology Group (ECOG) performance status, clinical laboratory evaluations (biochemistry, hematology and urine analysis), and any AE graded by using CTCAE v4.0.
Efficacy evaluations:
loco-regional control rate at 1 year, objective tumor response according to RECIST 1.1, progression free survival rate at 1 year, and pathological response (pR).
Body kinetic study:
the concentration of PEP503 will be quantified in whole blood and urine samples. The quantity of PEP503 in blood and urine samples will be measured by ICP-MS (Inductively Coupled Plasma Mass Spectrometry) analysis.
Intratumor dispersion evaluation:
CT-Scan images taken before and after radiation, and at the end of follow-up period during the study.
physical examination, vital signs, ECG, body weight, Eastern Cooperative Oncology Group (ECOG) performance status, clinical laboratory evaluations (biochemistry, hematology and urine analysis), and any AE graded by using CTCAE v4.0.
Efficacy evaluations:
loco-regional control rate at 1 year, objective tumor response according to RECIST 1.1, progression free survival rate at 1 year, and pathological response (pR).
Body kinetic study:
the concentration of PEP503 will be quantified in whole blood and urine samples. The quantity of PEP503 in blood and urine samples will be measured by ICP-MS (Inductively Coupled Plasma Mass Spectrometry) analysis.
Intratumor dispersion evaluation:
CT-Scan images taken before and after radiation, and at the end of follow-up period during the study.
Inclution Criteria
Inclusion Criteria
- Histologically or cytologically confirmed squamous cell carcinoma (SCC) of oral cavity.
- Advanced or recurrent disease: T4b, N any, who are not candidates for surgical resection; or T3-4, N any, who decline surgery or medical inoperable.
- 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:
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
- Adequate function of kidney:
Creatinine ≤ 1.5 x ULN
- Adequate function of liver:
AST ≤ 2.5 x ULN
ALT ≤ 2.5 x ULN
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.
- Histologically or cytologically confirmed squamous cell carcinoma (SCC) of oral cavity.
- Advanced or recurrent disease: T4b, N any, who are not candidates for surgical resection; or T3-4, N any, who decline surgery or medical inoperable.
- 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:
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
- Adequate function of kidney:
Creatinine ≤ 1.5 x ULN
- Adequate function of liver:
AST ≤ 2.5 x ULN
ALT ≤ 2.5 x ULN
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
Exclusion Criteria:
- Tumor ulceration combined with vascular risks.
- Prior radiotherapy to any area within the planned radiotherapy field.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active severe infection, symptomatic congestive heart failure, acute coronary syndrome, etc.
- Concurrent treatment with any other anticancer therapy, including immunotherapy, targeted therapy, gene therapy, or patients planning to receive these treatments during the study.
- 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, treatment plans, laboratory tests, and other study procedures or those with severe psychiatric illness/social situations that would limit compliance with study requirements.
- Preexisting neuropathy ≥ 2
- History of allergic reaction to platinum product.
- Without written informed consent to participate in the study.
- Tumor ulceration combined with vascular risks.
- Prior radiotherapy to any area within the planned radiotherapy field.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active severe infection, symptomatic congestive heart failure, acute coronary syndrome, etc.
- Concurrent treatment with any other anticancer therapy, including immunotherapy, targeted therapy, gene therapy, or patients planning to receive these treatments during the study.
- 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, treatment plans, laboratory tests, and other study procedures or those with severe psychiatric illness/social situations that would limit compliance with study requirements.
- Preexisting neuropathy ≥ 2
- History of allergic reaction to platinum product.
- Without written informed consent to participate in the study.
The Estimated Number of Participants
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Taiwan
60 participants
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Global
0 participants
