Clinical Trials List
Protocol NumberASP-1929-301
NCT Number(ClinicalTrials.gov Identfier)NCT03769506
2019-01-01 - 2028-12-31
Phase III
Recruiting6
Terminated1
ICD-10C44.42
Squamous cell carcinoma of skin of scalp and neck
A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP 1929 Photoimmunotherapy Versus Physician’s Choice Standard of Care for the Treatment of Locoregional, Recurrent Head and Neck Squamous Cell Carcinoma in Patients Who Have Failed or Progressed on or After at Least Two Lines of Therapy, of Which at Least One Line Must Be Systemic Therapy
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Trial Applicant
CMIC Asia-Pacific
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Sponsor
Rakuten Medical Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 戴世光 無
- Ling-Wei Wang 未分科
- Chia-Fan Chang 無
- Sheng-Yu Chen 無
- Mu-Hsin Chang 無
- Tsung-Lun Lee 未分科
- 朱本元 無
- 陳盛裕 未分科
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Co-Principal Investigator
- 廖俊達 未分科
- Ku-How Fang 未分科
- Cheng-Lung Hsu 未分科
- 葉智華 未分科
- 黃祥富 未分科
- Hung-Ming Wang 未分科
- 辛立仁 未分科
- 方瑞仁 未分科
- Chung-Jan Kang 未分科
- Chi-Ting Liau 未分科
- 王毓謙 未分科
- Tuan Jen Fang 未分科
- 戴曉芙 未分科
- Chia-Hsun Hsieh 未分科
- 林婉妮 未分科
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Head and Neck Squamous Cell Carcinoma
Objectives
To evaluate the efficacy and safety of ASP-1929 PIT as a monotherapy for the treatment of locoregional, recurrent HNSCC in patients who have failed or progressed on or after at least two lines of therapy, of which at least one line must be systemic therapy.
Test Drug
ASP-1929; Laser system PIT690.4-2500
Active Ingredient
Cetuximab-IR700: dye conjugate of the monoclonal antibody
Dosage Form
solution for IV infusion
Dosage
250 mg
Endpoints
First Primary:
• Progression Free Survival (PFS)
Second Primary:
• Overall Survival (OS)
Key Secondary:
• Objective Response Rate (ORR)
Other Secondary:
• Complete Response (CR)
• Complete Response by Biopsy (CRb)
• Duration of Response (DoR)
• Event-Free Survival (EFS)
• Objective unique target and non-target tumor(s) assessments and response rates using CT RECIST 1.1 with modifications and Choi criteria with modifications, and CT tumor volumetrics
• Eastern Cooperative Oncology Group (ECOG) performance status
• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and the head and neck specific module (EORTC QLQ-H&N 35)
• EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
• Presence of anti-drug antibodies (ADA)
• Population PK
• Progression Free Survival (PFS)
Second Primary:
• Overall Survival (OS)
Key Secondary:
• Objective Response Rate (ORR)
Other Secondary:
• Complete Response (CR)
• Complete Response by Biopsy (CRb)
• Duration of Response (DoR)
• Event-Free Survival (EFS)
• Objective unique target and non-target tumor(s) assessments and response rates using CT RECIST 1.1 with modifications and Choi criteria with modifications, and CT tumor volumetrics
• Eastern Cooperative Oncology Group (ECOG) performance status
• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and the head and neck specific module (EORTC QLQ-H&N 35)
• EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
• Presence of anti-drug antibodies (ADA)
• Population PK
Inclution Criteria
1. Patients with histologically confirmed locoregional persistent, recurrent or second primary squamous cell carcinoma of the Head and Neck, not amenable to curative treatment, including surgery, radiation, or platinum chemotherapy per treatment guidelines.
2. Patient must have failed or progressed on or after at least 2 lines of therapy for squamous cell carcinoma of the head and neck, one of which must be prior systemic platinum-based chemotherapy for treatment of their primary or recurrent head and neck cancer, unless in the opinion of the medical oncologist, the use of platinum-based chemotherapy is contraindicated or not recommended (eg, renal impairment, allergy to platinum compounds, age, myelosuppression, neuropathy, hearing loss, etc). Patients who are unable to receive systemic platinum-based chemotherapy should receive an appropriate alternative standard of care systemic therapy for their treatment instead of platinum-based chemotherapy.
a. First-line therapy: The first treatment given for a head and neck cancer. It is often part of a standard set of treatments, such as surgery followed by chemotherapy and radiation, or surgery and radiation, or radiation, or surgery, depending on the stage and location of the head and neck cancer. When used by itself, first line therapy is the one accepted as the best treatment.
b. Second-line and subsequent lines of therapy: Treatment that is given when initial treatment (first-line and additional lines of therapy) doesn't work or stops working (eg, checkpoint inhibitors may be considered if approved and medically indicated).
3. Patients must have completed prior curative radiation therapy for treatment of their head and neck region.
4. All locoregional head and neck tumor site(s) are accessible for light illumination treatment. The accessibility of tumor sites for light illumination treatment must be confirmed by a central radiology review prior to randomization.
5. Target tumors are clearly measurable by contrast enhanced CT scan (or MRI with gadolinium if CT scan is not adequate or the patient has an allergy to CT contrast media). Measurable disease must be confirmed by central radiology review prior to randomization.
6. Life expectancy > 6 months based on Investigator judgement.
7. Male or female patients at least 18 years old. Female patients must not be pregnant or breastfeeding and must be practicing a medically acceptable form of locally approved birth control, be sterile or post-menopausal. Male patients should be using a medically acceptable form of birth control during the trial or be sterile. See Section 5.1 for additional guidance.
8. Patients must have an ECOG score of 0 to 1.
9. Patients must understand the investigational nature of the trial, be willing to comply with all study procedures and follow-up, and patient or patient’s legal guardian must sign a written informed consent, per local regulations.
2. Patient must have failed or progressed on or after at least 2 lines of therapy for squamous cell carcinoma of the head and neck, one of which must be prior systemic platinum-based chemotherapy for treatment of their primary or recurrent head and neck cancer, unless in the opinion of the medical oncologist, the use of platinum-based chemotherapy is contraindicated or not recommended (eg, renal impairment, allergy to platinum compounds, age, myelosuppression, neuropathy, hearing loss, etc). Patients who are unable to receive systemic platinum-based chemotherapy should receive an appropriate alternative standard of care systemic therapy for their treatment instead of platinum-based chemotherapy.
a. First-line therapy: The first treatment given for a head and neck cancer. It is often part of a standard set of treatments, such as surgery followed by chemotherapy and radiation, or surgery and radiation, or radiation, or surgery, depending on the stage and location of the head and neck cancer. When used by itself, first line therapy is the one accepted as the best treatment.
b. Second-line and subsequent lines of therapy: Treatment that is given when initial treatment (first-line and additional lines of therapy) doesn't work or stops working (eg, checkpoint inhibitors may be considered if approved and medically indicated).
3. Patients must have completed prior curative radiation therapy for treatment of their head and neck region.
4. All locoregional head and neck tumor site(s) are accessible for light illumination treatment. The accessibility of tumor sites for light illumination treatment must be confirmed by a central radiology review prior to randomization.
5. Target tumors are clearly measurable by contrast enhanced CT scan (or MRI with gadolinium if CT scan is not adequate or the patient has an allergy to CT contrast media). Measurable disease must be confirmed by central radiology review prior to randomization.
6. Life expectancy > 6 months based on Investigator judgement.
7. Male or female patients at least 18 years old. Female patients must not be pregnant or breastfeeding and must be practicing a medically acceptable form of locally approved birth control, be sterile or post-menopausal. Male patients should be using a medically acceptable form of birth control during the trial or be sterile. See Section 5.1 for additional guidance.
8. Patients must have an ECOG score of 0 to 1.
9. Patients must understand the investigational nature of the trial, be willing to comply with all study procedures and follow-up, and patient or patient’s legal guardian must sign a written informed consent, per local regulations.
Exclusion Criteria
1. Patients with a history of significant (≥ Grade 3) cetuximab infusion reactions.
2. Patients who have been treated with prior systemic chemotherapy or targeted small molecule therapy or radiation therapy within 2 weeks of trial Day 1 or who have not recovered (ie, ≤ Grade 1 or at baseline) from adverse events, due to previously administered agent.
3. Patients who have been treated with an anticancer monoclonal antibody therapy within 4 weeks of trial Day 1 or who have not recovered, (ie, ≤ Grade 1 or at baseline) from adverse events due to the previously administered agent.
4. Patients who have been treated with an investigational agent or intervention within 4 weeks of trial Day 1 or who have not recovered (ie, ≤ Grade 1 or at baseline) from adverse events, due to previously administered agent or intervention.
5. Present history of distant metastatic disease (M1).
6. Patients who are actively undergoing treatment of or have a diagnosis of an active cancer other than nonmelanoma skin cancer or HNSCC.
7. Tumor in enhanced CT or MRI scan invading a major blood vessel (such as the carotid artery) unless the vessel has been embolized, stented, or surgically ligated to prevent potential bleeding from a blood vessel (hemorrhage) as confirmed by central radiology review before randomization.
8. Patients with a hemoglobin < 9.0 g/dL, WBC < 2000/µL, and platelets < 100 x 103/µL.
9. Patients with impaired hepatic function defined as alkaline phosphatase (hepatic; alkaline phosphatase [ALP]) > 2 times upper limit of normal, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times the upper limit of normal, or total serum bilirubin > 2 mg/dL (patients with Gilbert’s disease will be excluded if they have a bilirubin ≥ 5 mg/dL).
10. Patients with impairment of renal function (Cockcroft-Gault GFR (mL/min/1.73 m2) < 30). Cockcroft-Gault GFR Creatinine Clearance Value = {[(140–age) x weight (kg)] / (Scr x 72)} (x 0.85 for females).
11. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with trial requirements.
12. Patient requires examinations or treatments within 4 weeks after ASP 1929 administration where they would be exposed to significant light (eg, eye examinations, elective surgical procedures) unrelated to the study treatment.
13. Unwilling or unable to follow protocol requirements.
14. Any condition which in the Investigator’s opinion deems the patient an unsuitable candidate to receive study drug.
15. Patients that have been previously treated or randomized to any trial using ASP-1929 or RM-1929 as the study drug.
2. Patients who have been treated with prior systemic chemotherapy or targeted small molecule therapy or radiation therapy within 2 weeks of trial Day 1 or who have not recovered (ie, ≤ Grade 1 or at baseline) from adverse events, due to previously administered agent.
3. Patients who have been treated with an anticancer monoclonal antibody therapy within 4 weeks of trial Day 1 or who have not recovered, (ie, ≤ Grade 1 or at baseline) from adverse events due to the previously administered agent.
4. Patients who have been treated with an investigational agent or intervention within 4 weeks of trial Day 1 or who have not recovered (ie, ≤ Grade 1 or at baseline) from adverse events, due to previously administered agent or intervention.
5. Present history of distant metastatic disease (M1).
6. Patients who are actively undergoing treatment of or have a diagnosis of an active cancer other than nonmelanoma skin cancer or HNSCC.
7. Tumor in enhanced CT or MRI scan invading a major blood vessel (such as the carotid artery) unless the vessel has been embolized, stented, or surgically ligated to prevent potential bleeding from a blood vessel (hemorrhage) as confirmed by central radiology review before randomization.
8. Patients with a hemoglobin < 9.0 g/dL, WBC < 2000/µL, and platelets < 100 x 103/µL.
9. Patients with impaired hepatic function defined as alkaline phosphatase (hepatic; alkaline phosphatase [ALP]) > 2 times upper limit of normal, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times the upper limit of normal, or total serum bilirubin > 2 mg/dL (patients with Gilbert’s disease will be excluded if they have a bilirubin ≥ 5 mg/dL).
10. Patients with impairment of renal function (Cockcroft-Gault GFR (mL/min/1.73 m2) < 30). Cockcroft-Gault GFR Creatinine Clearance Value = {[(140–age) x weight (kg)] / (Scr x 72)} (x 0.85 for females).
11. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with trial requirements.
12. Patient requires examinations or treatments within 4 weeks after ASP 1929 administration where they would be exposed to significant light (eg, eye examinations, elective surgical procedures) unrelated to the study treatment.
13. Unwilling or unable to follow protocol requirements.
14. Any condition which in the Investigator’s opinion deems the patient an unsuitable candidate to receive study drug.
15. Patients that have been previously treated or randomized to any trial using ASP-1929 or RM-1929 as the study drug.
The Estimated Number of Participants
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Taiwan
27 participants
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Global
275 participants
