Head and Neck CancerPhase 2NCT05182866
ASP-1929 Photoimmunotherapy (PIT) Study in Patients With Recurrent Head/Neck Cancer
A Phase 2 study testing ASP-1929 Photoimmunotherapy in people with Head and Neck Cancer and Squamous Cell Carcinoma of Head and Neck, run by Rakuten Medical, Inc. at 1 site in United States.
Trial summary
A Phase 2, Open-label, Single-arm, Window of opportunity Study of ASP-1929 Photoimmunotherapy with Fluorescence Imaging in Patients with Operable Primary or Recurrent Head and Neck or Cutaneous Squamous Cell Carcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- ASP-1929 Photoimmunotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2022to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent.
- Male or female ≥ 18 years of age at the time of informed consent
- Documentation of histologically confirmed, resectable (by standard of care surgery), primary or recurrent locoregional HNSCC or cuSCC.
- Note: For patients with HNSCC, tumor locations must be in the oropharynx, oral cavity, sinonasal tract, hypopharynx, or larynx. Patients may not have a primary tumor site of nasopharynx (any histology).
- At least one tumor lesion accessible for ASP-1929 PIT illumination that is also amenable to imaging with the Fluorescence Imaging System camera (must be within 0.5 cm and no more than 3 cm depth to the skin or mucosal surface, with the longest diameter less than 5 cm as judged by pre-treatment imaging or examination) and radiographically measurable by RECIST 1.1, as assessed by the Investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of screening.
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- Adequate organ function laboratory values (all screening labs should be performed ≤ 14 days of Day 1)
- Female patients of childbearing potential must not be pregnant (confirmed by negative pregnancy test [urine or serum] at screening), not breastfeeding and must be willing to use a method of highly effective birth control, or practice abstinence throughout the study and for 60 days after the last dose of ASP-1929.
- Male patients must be sterile or agree to use an adequate method of contraception or practice abstinence throughout the study and for 60 days after the last dose of ASP-1929
- Provide fresh tumor biopsy at screening. Patients for whom a fresh screening biopsy cannot be obtained may submit an archival sample provided it has been collected within ≤ 3 months of enrollment and no intervening anticancer treatment has occurred within that timeframe or upon agreement from the Sponsor.
Who cannot join
- Receiving any other investigational agents or who have received local (including radiotherapy) or systemic treatment for cancer (chemotherapy, immunotherapy, any systemic investigational therapy, or EGFR-directed therapy) within 4 weeks before ASP-1929 PIT treatment.
- History of significant (≥ Grade 3) infusion reaction to anti-EGFR antibodies.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ASP-1929, or other agents used in study.
- Require use of photosensitizing medications. Note: Photosensitizing medications must be discontinued 30 days before ASP-1929 PIT treatment.
- Tumor invading major blood vessel unless the vessel has been embolized or surgically ligated to prevent hemorrhage; must not have involvement of the common or internal carotid arteries defined as invasion, encasement or direct contact (lack of a radiographically visible plane between the tumor and carotid artery).
- Tumors inappropriate for ASP-1929 PIT treatment, including those in the brain or dura, with perineural involvement at the skull base, CNS disease, or disease in the orbit (if the eye has been previously removed, consult with Medical Monitor before excluding).
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- History of distant metastatic disease (M1) based on standard of care imaging.
- Any contraindications for CT or 18FDG PET/CT imaging.
- Weight > 350 pounds (weight limit for scanner table), or unable to fit within the imaging gantry.
- Requiring future examinations or treatments within 4 weeks after an ASP-1929 PIT treatment cycle exposing the patient to high-intensity light (eg, eye examinations, surgical procedures) that are unrelated to ASP-1929 PIT treatment, the disease under study, or the study overall.
- Diagnosed and/or treated for additional malignancy within 3 years before study Day 1, except for those with a negligible risk of metastasis or death
- Known history of testing positive for human immunodeficiency virus or acquired immunodeficiency syndrome -related illness.
- Known infection or detection of active Hepatitis B (eg, HBsAg positive), Hepatitis C (eg, RNA [qualitative]), or SARS-CoV-2 (qualitative).
- Received a live, attenuated vaccine within 4 weeks before Day 1 or anticipation of receiving a live, attenuated vaccine that will be required during the study (based on known medical history).
- 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 study requirements.
- Major surgery or significant traumatic injury within 4 weeks of study Day 1, or anticipation of the need for major surgery that is unrelated to study intervention during the study.
- Currently participating or has participated in a study of any investigational agent or used any investigational device within 4 weeks of study Day 1.
- Unwilling or unable to follow protocol requirements.
- Any other condition which, in the Investigator's opinion, deems the patient an unsuitable candidate to receive ASP-1929 and/or be exposed to illumination, may affect the interpretation of the results, or render the patient at high risk from treatment complications.
- Active infection requiring systemic therapies such as antibiotic, antifungal, or antiviral intervention which in the opinion of the Investigator precludes the patient from participating in the clinical trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Cancer Research
Bethesda, Maryland, 20892
About this study
Official title: Phase 2, Open-label, Single-arm, Window of Opportunity Study of ASP-1929 Photoimmunotherapy With Fluorescence Imaging in Patients With Operable Primary or Recurrent Head and Neck or Cutaneous Squamous Cell Carcinoma
A Phase 2, Open-label, Single-arm, Window of opportunity Study of ASP-1929 Photoimmunotherapy with Fluorescence Imaging in Patients with Operable Primary or Recurrent Head and Neck or Cutaneous Squamous Cell Carcinoma
Read the detailed description
All patients will receive a combination of ASP-1929 and Photoimmunotherapy (PIT). During illumination procedure, fluorescence of the IR700 component of ASP-1929 will be imaged at a wavelength in the vicinity of 830 nm with a Shimadzu Fluorescence Imaging System camera. Patients will undergo standard of care surgery approximately 21 days after ASP-1929 PIT treatment.
- Being tested
- ASP-1929 Photoimmunotherapy
- Keywords
- Photoimmunotherapy, HNC, HNSCC, Head and neck, Rakuten Medical, ASP-1929, Fluorescence
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP-1929 PhotoimmunotherapyCombination product
ASP-1929 640 mg/m^2 IV infusion followed approximately 24 hours later by photoimmunotherapy
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | ASP-1929 640 mg/m^2 treatment by intravenous (IV) infusion followed approximately 24 hours later by illumination (also termed as photoimmunotherapy [PIT]) of tumor(s) using the PIT690 Laser System with a 690 nm light dose of 50 J/cm^2 for superficial illumination and 100 J/cm of diffuser length for interstitial illumination. During the illumination procedure, fluorescence of the IR700 component of ASP-1929 will be imaged with a Shimadzu Fluorescence Imaging System camera. Patients will undergo standard of care surgery with or without chemotherapy or radiation approximately 21 days after ASP-1929 PIT treatment. Receives: Combination Product: ASP-1929 Photoimmunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Tumor Response
Proportion of patients with pathologic tumor response-2 (pTR-2) of ASP-1929 PIT-treated lesions. A patient is a pTR-2 responder if overall pTR of ASP-1929 PIT-treated tumors (including primary tumor and lymph node) is greater than or equal to 50% (pTR-2)
Measured: Day 17 or Day 21
Secondary outcomes (9)
Local relapse rate
Local relapse rate (at ASP-1929 PIT-treated site) at one year after surgery
Measured: 12 Months
Time to local relapse at ASP-1929 PIT-treated site
Time to local relapse at ASP-1929 PIT-treated site is defined as the time from the day of surgery to local regional and/or distant relapse at ASP-1929 PIT-treated site.
Measured: 12 Months
Progression-free Survival (PFS)
PFS defined as time from initial study intervention to progress disease, precluding surgery, locoregional recurrence, distant recurrence, second primary tumor (with biopsy confirmation where possible), or death from any cause.
Measured: 12 Months
Recurrence-free survival (RFS)
RFS defined as time from the day of surgery to first recurrence (locoregional or distant)
Measured: 12 Months
Overall Survival
Overall survival is defined as the time from the first treatment to death from any cause.
Measured: 24 Months
Proportion of patients with treatment-emergent adverse events related to ASP-1929 PIT treatment
Measured: 1 Month
Proportion of patients with surgery delay due to ASP-1929 PIT treatment
Measured: Day 17 or Day 21
Proportion of successful fluorescence observation
Measured: Day 2
Time to maximal fluorescence loss (TMFL) of IR700
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start21 Jan 2022
- Primary completion11 Jul 2024
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rakuten Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shimadzu Corporation, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Vassiliki Saloura, MD, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182866
- Sponsor's protocol ID
- ASP-1929-103
- Status last verified
- Aug 2024
- First submitted
- 20 Dec 2021
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Open-label, Single-arm, Window of Opportunity Study of ASP-1929 Photoimmunotherapy With Fluorescence Imaging in Patients With Operable Primary or Recurrent Head and Neck or Cutaneous Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05182866
- Acronym / sponsor ID
- ASP-1929-103
- Keywords
- Photoimmunotherapy, HNC, HNSCC, Head and neck, Rakuten Medical, ASP-1929, Fluorescence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Rakuten Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Shimadzu Corporation, National Cancer Institute (NCI)
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 11 Jul 2024 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2, Open-label, Single-arm, Window of opportunity Study of ASP-1929 Photoimmunotherapy with Fluorescence Imaging in Patients with Operable Primary or Recurrent Head and Neck or Cutaneous Squamous Cell Carcinoma
Detailed description
All patients will receive a combination of ASP-1929 and Photoimmunotherapy (PIT). During illumination procedure, fluorescence of the IR700 component of ASP-1929 will be imaged at a wavelength in the vicinity of 830 nm with a Shimadzu Fluorescence Imaging System camera. Patients will undergo standard of care surgery approximately 21 days after ASP-1929 PIT treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Combination Product: ASP-1929 PhotoimmunotherapyASP-1929 640 mg/m^2 treatment by intravenous (IV) infusion followed approximately 24 hours later by illumination (also termed as photoimmunotherapy [PIT]) of tumor(s) using the PIT690 Laser System with a 690 nm light dose of 50 J/cm^2 for superficial illumination and 100 J/cm of diffuser length for interstitial illumination. During the illumination procedure, fluorescence of the IR700 component of ASP-1929 will be imaged with a Shimadzu Fluorescence Imaging System camera. Patients will undergo standard of care surgery with or without chemotherapy or radiation approximately 21 days after ASP-1929 PIT treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Provide written informed consent.
- Male or female ≥ 18 years of age at the time of informed consent
- Documentation of histologically confirmed, resectable (by standard of care surgery), primary or recurrent locoregional HNSCC or cuSCC.
- Note: For patients with HNSCC, tumor locations must be in the oropharynx, oral cavity, sinonasal tract, hypopharynx, or larynx. Patients may not have a primary tumor site of nasopharynx (any histology).
- At least one tumor lesion accessible for ASP-1929 PIT illumination that is also amenable to imaging with the Fluorescence Imaging System camera (must be within 0.5 cm and no more than 3 cm depth to the skin or mucosal surface, with the longest diameter less than 5 cm as judged by pre-treatment imaging or examination) and radiographically measurable by RECIST 1.1, as assessed by the Investigator.
Key exclusion criteria (20 listed)
- Receiving any other investigational agents or who have received local (including radiotherapy) or systemic treatment for cancer (chemotherapy, immunotherapy, any systemic investigational therapy, or EGFR-directed therapy) within 4 weeks before ASP-1929 PIT treatment.
- History of significant (≥ Grade 3) infusion reaction to anti-EGFR antibodies.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ASP-1929, or other agents used in study.
- Require use of photosensitizing medications. Note: Photosensitizing medications must be discontinued 30 days before ASP-1929 PIT treatment.
- Tumor invading major blood vessel unless the vessel has been embolized or surgically ligated to prevent hemorrhage; must not have involvement of the common or internal carotid arteries defined as invasion, encasement or direct contact (lack of a radiographically visible plane between the tumor and carotid artery).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP-1929 PhotoimmunotherapyASP-1929 640 mg/m^2 IV infusion followed approximately 24 hours later by photoimmunotherapy | Combination product | Single Arm |
Primary outcome
Pathologic Tumor Response
Time frame: Day 17 or Day 21
Proportion of patients with pathologic tumor response-2 (pTR-2) of ASP-1929 PIT-treated lesions. A patient is a pTR-2 responder if overall pTR of ASP-1929 PIT-treated tumors (including primary tumor and lymph node) is greater than or equal to 50% (pTR-2)
9 secondary outcomes
Local relapse rate
Time frame: 12 Months
Time to local relapse at ASP-1929 PIT-treated site
Time frame: 12 Months
Progression-free Survival (PFS)
Time frame: 12 Months
Recurrence-free survival (RFS)
Time frame: 12 Months
Overall Survival
Time frame: 24 Months
Proportion of patients with treatment-emergent adverse events related to ASP-1929 PIT treatment
Time frame: 1 Month
Proportion of patients with surgery delay due to ASP-1929 PIT treatment
Time frame: Day 17 or Day 21
Proportion of successful fluorescence observation
Time frame: Day 2
Time to maximal fluorescence loss (TMFL) of IR700
Time frame: Day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vassiliki Saloura, MD principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASP-1929 Photoimmunotherapy in people with Head and Neck Cancer and Squamous Cell Carcinoma of Head and Neck, run by Rakuten Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Tumor Response (time frame: Day 17 or Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.