Locoregional, recurrent head and neck squamous cell carcinoma MedDRA version: 20.0 Level: PT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Cetuximab-IR700
Product Code: ASP-1929
Pharmaceutical Form: Infusion
INN or Proposed INN: cetuximab sarotalocan
CAS Number: 2166339-33-7
Current Sponsor code: ASP-1929
Other descriptive
Sponsors
Rakuten Aspyrian, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 (e.g., 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 therapy and additional lines of therapy) doesn't work or stops working. (e.g. 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 cancer. 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. a. Male patients: A male patient must agree to use contraception as detailed in Section 10.4 (Appendix 4 of Protocol) of this protocol during the treatment period and for at least 6 months after the last ASP-1929 infusion and refrain from donating sperm during this period. b. Female patient: A female patient is eligible to participate if she is not pregnant(see Section 10.4, Appendix 4 of Protocol), not breastfeeding, and at least one of the following conditions applies: i. Not a woman of childbearing potential (WOCBP) as defined in Section 10.4, Appendix 4 of Protocol OR ii. A WOCBP who agrees to follow the contraceptive guidance in Section 10.4, Appendix 4 of Protocol, during the treatment period and for at least 6 months after the last dose of trial intervention and must refrain from breastfeeding for at least 2 months after the last ASP-1929 infusion. 8.
Exclusion criteria
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 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 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 prior to randomization. 8. Patients with a hemoglobin 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 (unless the patient has Gilbert’s disease). 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 who have been previously treated or randomized to any trial using ASP-1929 or RM-1929 as the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of ASP-1929 PIT as a monotherapy for the treatment of locoregional, recurrent head and neck squamous cell carcinoma (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.;Secondary Objective: Not applicable;Primary end point(s): •Progression-Free Survival (PFS) •Overall Survival (OS);Timepoint(s) of evaluation of this end point: See Figure 1 in protocol: Patients who continue in the treatment (up to 12 months): every 4 weeks for the first 25 weeks then every 8 weeks for the next 27 weeks. Patients with progressive disease will be moved to long-term follow up and be contacted every 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Objective Response Rate (ORR) •Complete Response (CR) • Complete Response by Biopsy (CRb) • Duration of Response (DoR) • Event-Free Survivial (EFS) • Objective unique target and non-target tumor(s) assessment and response rates using CT RECIST 1.1, Choi criteria, and CT tumor volumetrics • Presence of anti-drug antibodies (ADA) • Population PK ;Timepoint(s) of evaluation of this end point: See Figure 1 in protocol: Patients who continue in the treatment (up to 12 months): every 4 weeks for the first 25 weeks then every 8 weeks for the next 27 weeks. Patients with progressive disease will be moved to long-term follow up and be contacted every 12 weeks | — |
Countries
Belgium, France, Germany, Greece, Hungary, Italy, Japan, Korea, Republic of, Netherlands, Poland, Spain, Taiwan, United States
Contacts
Public ContactManager of Operations
Rakuten Aspyrian, Europe GmbH
Outcome results
None listed