ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head and Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy
- Conditions
- Squamous Cell Carcinoma of Head and NeckD000077195
- Registration Number
- JPRN-jRCT2071200060
- Lead Sponsor
- Arron Sarah
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 275
Patients must meet the following criteria to be eligible for study participation:
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. 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.
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.
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).
6. Life expectancy > 6 months based on Investigator judgement.
7. Male or female patients at least 18 years old.
8. Patients must have an ECOG score of 0 to 1.
Patients with any of the following will be excluded from participation in the study:
1. Patients with a history of significant (Grade 3 or greater) 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 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, 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 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 < 9.0g/dL, WBC < 2000/uL, and platlets < 100 x10^3/uL.
9. Patients with impaired hepatic function.
10. Patients with impairment of renal function.
11. Uncontrolled intercurrent illness.
12. Patient requires examinations or treatments within 4 weeks after ASP-1929 administration where they would be exposed to significant light unrelated to the study treatment.
13. Patients who have been previously treated or randomized to any trial using ASP-1929 or RM-1929 as the study treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-Free Survival: Time to progression of disease,<br>Overall Survival: Duration of survival
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR)<br>Complete Response (CR)<br>Complete Response by Biopsy (CRb)<br>Duration of Response (DoR)<br>Event-Free Survivial (EFS)<br>Response rates using CT RECIST 1.1, Choi criteria, and CT tumor volumetrics<br>Eastern Cooperative Oncology Group performance status<br>EORTC QLQ-C30 and EORTC QLQ-H&N 35<br>EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire <br>Presence of anti-drug antibodies (ADA)<br>Population PK