Head and Neck CancerPhase 2NCT05265013
ASP-1929 Photoimmunotherapy Combined With Pembrolizumab in Patients With Recurrent Head and Neck Cancer, With or Without Metastases
A Phase 2 study testing ASP-1929 Photoimmunotherapy and pembrolizumab in people with Head and Neck Cancer, run by Rakuten Medical, Inc. at 5 sites in Taiwan.
Trial summary
A Phase 2 Single-arm Study of ASP-1929 Photoimmunotherapy Combined With Pembrolizumab in Patients With Locoregional Recurrent Squamous Cell Carcinoma of the Head and Neck, With or Without Metastases, Not Amenable to Curative Local Treatment Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- ASP-1929 Photoimmunotherapy and pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 5 sitesTaiwan
- Study dates
- 19 Apr 2022to 29 Mar 2024
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent.
- Male or female ≥ 20 years of age at the time of signing informed consent.
- Have histologically or cytologically confirmed and diagnosed locoregional recurrent or second primary squamous cell carcinoma of the head and neck, not amenable to curative local treatment (ie, surgery and radiation therapy) per treatment guidelines. Patients with distant metastases are eligible.
- Have provided tissue for biomarker analysis from a fresh core or excisional biopsy. A newly obtained screening biopsy (prior to start of study treatment with no intervening anticancer treatment from time of biopsy collection to C1D1) is strongly preferred but an archival sample is acceptable provided it has been collected within ≤ 6 months of enrollment and no intervening anticancer treatment has occurred within that timeframe or upon agreement from the Sponsor.
- Disease progression after treatment with a platinum-containing regimen for recurrent (disease not amenable to curative treatment)/metastatic disease. Note: disease progression may occur at any time during or after a platinum-containing regimen (eg, carboplatin or cisplatin) which was administered in the recurrent/metastatic setting.
- Note: Patients who were ineligible or unable to receive platinum therapy may be eligible after failing or progressing after suitable alternative systemic therapy (eg, 5-FU, cetuximab).
Show all 22Show fewer
- Anti-PD-1 treatment naive.
- Completed prior curative radiation therapy for treatment of the head and neck region, unless, in the opinion of the investigator, the use of radiation therapy was contraindicated or not recommended.
- At least one recurrent head and neck tumor that is both accessible for illumination (as assessed by investigator) and radiographically measurable by RECIST v1.1 as assessed by an independent central reviewer (ICR) and the investigator. Lesions located in a previously irradiated area are considered measurable if progression has been demonstrated.
- Accessible tumors may be superficial lesions that are amenable to superficial illumination, regional metastatic lesions such as accessible lymph nodes, or deeper tumors that may be illuminated interstitially using cylindrical diffusers.
- Tumors that require needle catheters to go through bone (except tumors inside paranasal sinuses), arteries, major veins, eye globes, dura, or brain (including perineural invasion extending to the skull base) are not suitable for PIT illumination.
- Combined positive score (CPS) ≥ 1 (as determined by a Taiwan Food and Drug Administration/TFDA approved test).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of screening.
- Life expectancy ≥ 3 months based on investigator judgement.
- Adequate organ function laboratory values as described below (all screening labs should be performed ≤ 7 days of C1D1):
- Hematology: Adequate bone marrow function as shown by absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin (Hb) ≥ 9 g/dL. Transfusions and growth factors must not be used within 2 weeks prior to C1D1 to meet these requirements.
- Hepatic: Alkaline phosphatase (ALP) ≤ 2 times upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (≤ 5 times ULN for patients with liver metastases), and total serum bilirubin ≤ 2 mg/dL (unless the patient has Gilbert's disease).
- Renal: estimated glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m² to be calculated per the CKD-EPI equation below:
- GFR = 141 min (Scr/κ,1)ᵅ max(Scr/κ, 1)-¹.²⁰⁹ 0.993ᵃᵍᵉ 1.018 [if female] 1.159 [if Black] Note: Scr is serum creatinine (mg/dL), κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/κ or 1, and max indicates the maximum of Scr/κ or 1.
- Coagulation: International Normalized Ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN, unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants.
- Female patients of childbearing potential must not be pregnant (confirmed by negative pregnancy test [urine or serum] at screening) or breastfeeding and must be willing to use 2 methods of highly effective birth control or practice abstinence throughout the study and for 120 days after the last dose of study medication. Females of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
- Male patients must be sterile or agree to use an adequate method of contraception or practice abstinence starting with the first dose of study medication through 120 days after the last dose of study treatment.
Who cannot join
- Patients will be excluded if any of the following criteria apply:
- Medical History
- Diagnosed and/or treated for an additional malignancy within 5 years prior to study C1D1, except for those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ). Patients with a history of other prior cancer with no evidence of disease may be eligible based on discussion with the medical monitor.
- Tumor invading a 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). Decision to exclude may be determined either by a central reviewer or by the investigator.
- Tumors inappropriate for ASP-1929 PIT treatment, including those in the brain or dura, with perineural involvement at the skull base, CNS (Central nervous system) disease, or disease in the orbit (if the eye has been previously removed, consult with the medical monitor before excluding). Decision to exclude may be determined by a central reviewer or the investigator.
- Known or active central nervous system metastases and/or carcinomatous meningitis.
Show all 30Show fewer
- Active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
- Note: Patients with type I diabetes mellitus or hypothyroidism requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are not excluded.
- Evidence of interstitial lung disease or current active, non-infectious pneumonitis.
- 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.
- Prior allogeneic tissue/solid organ transplant.
- History of significant (≥ grade 3) infusion reactions to anti-EGFR (EGFR, epidermal growth factor receptor) antibodies.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ASP-1929 or pembrolizumab.
- Known history of testing positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- Known infection or detection of active Hepatitis B (eg, HBsAg positive), active Hepatitis C (eg, RNA [qualitative]), or SARS-CoV-2 (qualitative).
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Any other condition which, in the investigator's opinion, deems the patient an unsuitable candidate to receive pembrolizumab, ASP-1929, and/or be exposed to illumination, may affect the interpretation of the results, or may render the patient at high risk from treatment complications.
- Prior and Concomitant Procedures
- Major surgery or significant traumatic injury within 4 weeks prior to C1D1, or anticipation of the need for major surgery during the study.
- Note: If patient has had major surgery, they must have recovered adequately (as determined by the investigator) from the toxicity and/or complications before C1D1.
- 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 the ASP-1929 PIT treatment, the disease under study, or the study overall).
- Prior and Concomitant Medications
- Prior receipt of anticancer treatment as follows:
- Prior systemic chemotherapy or targeted small molecule therapy or radiation therapy within 2 weeks of C1D1 or has not recovered (ie, ≤ Grade 1 or at baseline) from adverse events due to previously administered agent.
- Prior anticancer monoclonal antibody therapy or investigational agent or intervention within 4 weeks of C1D1 or has not recovered (ie, ≤ Grade 1 or at baseline) from adverse events due to previously administered agent.
- Prior receipt of ASP-1929 at any time.
- Receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior to C1D1.
- Received a live, attenuated vaccine within 4 weeks before C1D1 or anticipation of receiving a live, attenuated vaccine during the study (based on known medical history).
- Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (eg, Flu-Mist®) are live attenuated vaccines and are not allowed.
- Unwilling or unable to follow protocol requirements.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Taiwan5 sites
China Medical University Hospital
Taichung, 40447
Taichung Veterans General Hospital
Taichung, 40705
National Taiwan University Hospital
Taipei, 10048
Taipei Veterans General Hospital
Taipei, 11217
Chang Gung Memorial Hospital
Taoyuan, 33305
About this study
Official title: A Phase 2 Single-arm Study of ASP-1929 Photoimmunotherapy Combined With Pembrolizumab in Patients With Locoregional Recurrent Squamous Cell Carcinoma of the Head and Neck, With or Without Metastases, Not Amenable to Curative Local Treatment
A Phase 2 Single-arm Study of ASP-1929 Photoimmunotherapy Combined With Pembrolizumab in Patients With Locoregional Recurrent Squamous Cell Carcinoma of the Head and Neck, With or Without Metastases, Not Amenable to Curative Local Treatment
Read the detailed description
A Single-arm Study of ASP-1929 Photoimmunotherapy Combined With Pembrolizumab.
Patients will receive the approved label dose of pembrolizumab, which is administered every 3 weeks on days 1 and 22 of each treatment cycle.
On Day 8 of each cycle, patients will receive ASP-1929 followed by illumination at accessible tumor sites using the investigational PIT690 Laser System on Day 9.
Each treatment cycle, which is driven by ASP-1929 PIT frequency of administration, will last 42 days. Patients will be treated with ASP-1929 PIT and pembrolizumab for up to 12 months with a maximum of 8 treatment cycles.
- Conditions
- Head and Neck Cancer
- Being tested
- ASP-1929 Photoimmunotherapy, pembrolizumab
- Keywords
- Rakuten Medical, ASP-1929, PIT, Photoimmunotherapy, HNC, HNSCC, Head and neck, pembrolizumab
- 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
Also called cetuximab sarotalocan, PIT690 Laser System
ASP-1929 640 mg/m^2 IV infusion followed by illumination with light dose of 50 J/cm^2 for superficial lesions and 100 J/cm for interstitial lesions within 24 +/- 4 hours after the end of ASP-1929 infusion
pembrolizumabBiological
Also called Keytruda
200 mg every three weeks on days 1 and 22 of each 6-week cycle, 30 minute IV infusion
| Study group | Role | What they receive |
|---|---|---|
| ASP-1929 Photoimmunotherapy Combined With Pembrolizumab | Experimental | Patients will receive the approved label dose of pembrolizumab, which is administered every 3 weeks on days 1 and 22 of each treatment cycle.
On Day 8 of each cycle, patients will receive ASP-1929 followed by illumination at accessible tumor sites using the investigational PIT690 Laser System on Day 9.
Each treatment cycle, which is driven by ASP-1929 PIT frequency of administration, will last 42 days. Patients will be treated with ASP-1929 PIT and pembrolizumab for up to 12 months with a maximum of 8 treatment cycles. Receives: Combination Product: ASP-1929 Photoimmunotherapy; Biological: pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR-PIT)
the proportion of patients with confirmed PIT-treated tumor response of complete response (CR) or partial response (PR) per RECIST 1.1, as assessed by central reviewer.
Measured: 24 months
Secondary outcomes (21)
Duration of Response, for PIT-treated lesions
Duration of Response (DoR; Duration of Response is defined as the time from first response (CR or PR) to the time of disease progression (PD) of PIT-treated lesions per RECIST 1.1, as assessed by central reviewer.
Measured: 24 months
Assess effects on tumor response, for PIT-treated lesions
Disease Control Rate (complete response, CR + partial response, PR + stable disease, SD) for PIT-treated lesions per RECIST 1.1, as assessed by central reviewer.
Measured: 24 months
Assess effects on tumor response, Confirmed ORR for all lesions
For all lesions per RECIST 1.1, as assessed by central reviewer:
- Confirmed ORR (CR or PR)
Measured: 24 months
Assess effects on tumor response, Disease control rate for all lesions
For all lesions per RECIST 1.1, as assessed by central reviewer:
- Disease control rate (DCR)
Measured: 24 months
Assess effects on tumor response, DoR for all lesions
For all lesions per RECIST 1.1, as assessed by central reviewer:
- DoR
Measured: 24 months
Assess effects on survival, PFS
Progression-free Survival (PFS)
Measured: 24 months
Assess effects on survival, OS
Overall Survival (OS)
Measured: 24 months
Characterize safety and tolerability
Proportion of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs) by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: 24 months
Assess effects on quality of life, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). It has four-point scales for the first 28 items. The minimum value is 1 and maximum value is 4. Higher scores mean a worse outcome. Overall health was evaluated as a 7-point response scale as the other two questions in that scale. The minimum value is 1 and maximum value is 7. Higher scores mean a better outcome.
Measured: 12 months
Assess effects on quality of life, EORTC head and neck specific module (EORTC QLQ H&N 35)
Change from baseline in EORTC head and neck specific module (EORTC QLQ H\&N 35). It has 4-point scales for the first 30 items. The minimum value is 1 and maximum value is 4. It has 2-point scales for the last 5 items. The minimum value is 1 and maximum value is 2. For all items and scales, high scores indicate more problems.
Measured: 12 months
Assess effects on quality of life, Functional Assessment of Cancer Therapy Head & Neck Cancer Symptom Index - 10 Item (FHNSI-10)
Proportion of patients who achieve a clinically meaningful benefit in symptoms, as measured by a 5-point improvement in Functional Assessment of Cancer Therapy Head \& Neck Cancer Symptom Index - 10 Item (FHNSI-10) from baseline to measured best assessment. The minimum value is 0 and maximum value is 4. Higher scores mean a worse outcome.
Measured: 12 months
Characterize population pharmacokinetics of ASP-1929, AUC₀-ₜ (AUC, area under the concentration-time curve)
Area under the concentration-time curve from time 0 through the last measurable time point.
Measured: 12 months
Characterize population pharmacokinetics of ASP-1929, AUC₀-₂₆
Area under the concentration-time curve from time 0 until 26 hours after infusion initiation (just prior to light treatment).
Measured: 12 months
Characterize population pharmacokinetics of ASP-1929, AUC₀-∞
Area under the concentration-time curve from time 0 through the last measurable time point and extrapolated to infinity.
Measured: 12 months
Characterize population pharmacokinetics of ASP-1929, AUCₐₗₗ
Area under the concentration-time curve using all available data from 0 through 2 weeks post dose.
Measured: 12 months
Characterize population pharmacokinetics of ASP-1929, Cₘₐₓ (maximum observed drug concentration)
Maximum observed concentration.
Measured: 12 months
Characterize population pharmacokinetics of ASP-1929, tₘₐₓ (time to maximal concentration)
Time of maximum observed concentration.
Measured: 12 months
Characterize population pharmacokinetics of ASP-1929, t₁/₂ (mean terminal elimination half-life)
The observed terminal elimination half-life.
Measured: 12 months
Characterize population pharmacokinetics of ASP-1929, CL (volume of serum cleared of drug per unit time)
The volume of serum cleared of drug per unit time following IV dosing (ASP-1929 only).
Measured: 12 months
Characterize population pharmacokinetics of ASP-1929, Vₛₛ (volume of distribution at steady state following intravenous administration)
Volume of distribution following IV dosing (ASP-1929 only).
Measured: 12 months
Characterize presence of anti-drug antibodies (ADA)
Proportion of patients with anti-ASP-1929 antibodies.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start19 Apr 2022
- Primary completion20 Nov 2023
- Study completion29 Mar 2024
Why it stopped: Business decision
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
- Model description
- ASP-1929 Photoimmunotherapy Combined With Pembrolizumab
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rakuten Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265013
- Sponsor's protocol ID
- ASP-1929-218
- Status last verified
- Oct 2024
- First submitted
- 25 Jan 2022
- Last updated
- 4 Nov 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Single-arm Study of ASP-1929 Photoimmunotherapy Combined With Pembrolizumab in Patients With Locoregional Recurrent Squamous Cell Carcinoma of the Head and Neck, With or Without Metastases, Not Amenable to Curative Local Treatment
- ClinicalTrials.gov ID
- NCT05265013
- Acronym / sponsor ID
- ASP-1929-218
- Conditions
- Head and Neck Cancer
- Keywords
- Rakuten Medical, ASP-1929, PIT, Photoimmunotherapy, HNC, HNSCC, Head and neck, pembrolizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Rakuten Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 3 Mar 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 Single-arm Study of ASP-1929 Photoimmunotherapy Combined With Pembrolizumab in Patients With Locoregional Recurrent Squamous Cell Carcinoma of the Head and Neck, With or Without Metastases, Not Amenable to Curative Local Treatment
Detailed description
A Single-arm Study of ASP-1929 Photoimmunotherapy Combined With Pembrolizumab.
Patients will receive the approved label dose of pembrolizumab, which is administered every 3 weeks on days 1 and 22 of each treatment cycle.
On Day 8 of each cycle, patients will receive ASP-1929 followed by illumination at accessible tumor sites using the investigational PIT690 Laser System on Day 9.
Each treatment cycle, which is driven by ASP-1929 PIT frequency of administration, will last 42 days. Patients will be treated with ASP-1929 PIT and pembrolizumab for up to 12 months with a maximum of 8 treatment cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- ASP-1929 Photoimmunotherapy Combined With Pembrolizumab
| Arm | Type | Receives |
|---|---|---|
| ASP-1929 Photoimmunotherapy Combined With Pembrolizumab | Experimental | Combination Product: ASP-1929 Photoimmunotherapy, Biological: pembrolizumabPatients will receive the approved label dose of pembrolizumab, which is administered every 3 weeks on days 1 and 22 of each treatment cycle. On Day 8 of each cycle, patients will receive ASP-1929 followed by illumination at accessible tumor sites using the investigational PIT690 Laser System on Day 9. Each treatment cycle, which is driven by ASP-1929 PIT frequency of administration, will last 42 days. Patients will be treated with ASP-1929 PIT and pembrolizumab for up to 12 months with a maximum of 8 treatment cycles. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Provide written informed consent.
- Male or female ≥ 20 years of age at the time of signing informed consent.
- Have histologically or cytologically confirmed and diagnosed locoregional recurrent or second primary squamous cell carcinoma of the head and neck, not amenable to curative local treatment (ie, surgery and radiation therapy) per treatment guidelines. Patients with distant metastases are eligible.
- Have provided tissue for biomarker analysis from a fresh core or excisional biopsy. A newly obtained screening biopsy (prior to start of study treatment with no intervening anticancer treatment from time of biopsy collection to C1D1) is strongly preferred but an archival sample is acceptable provided it has been collected within ≤ 6 months of enrollment and no intervening anticancer treatment has occurred within that timeframe or upon agreement from the Sponsor.
- Disease progression after treatment with a platinum-containing regimen for recurrent (disease not amenable to curative treatment)/metastatic disease. Note: disease progression may occur at any time during or after a platinum-containing regimen (eg, carboplatin or cisplatin) which was administered in the recurrent/metastatic setting.
Key exclusion criteria (30 listed)
- Medical History
- Diagnosed and/or treated for an additional malignancy within 5 years prior to study C1D1, except for those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ). Patients with a history of other prior cancer with no evidence of disease may be eligible based on discussion with the medical monitor.
- Tumor invading a 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). Decision to exclude may be determined either by a central reviewer or by the investigator.
- Tumors inappropriate for ASP-1929 PIT treatment, including those in the brain or dura, with perineural involvement at the skull base, CNS (Central nervous system) disease, or disease in the orbit (if the eye has been previously removed, consult with the medical monitor before excluding). Decision to exclude may be determined by a central reviewer or the investigator.
- Known or active central nervous system metastases and/or carcinomatous meningitis.
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 PhotoimmunotherapyAlso: cetuximab sarotalocan, PIT690 Laser SystemASP-1929 640 mg/m^2 IV infusion followed by illumination with light dose of 50 J/cm^2 for superficial lesions and 100 J/cm for interstitial lesions within 24 +/- 4 hours after the end of ASP-1929 infusion | Combination product | ASP-1929 Photoimmunotherapy Combined With Pembrolizumab |
| pembrolizumabAlso: Keytruda200 mg every three weeks on days 1 and 22 of each 6-week cycle, 30 minute IV infusion | Biological | ASP-1929 Photoimmunotherapy Combined With Pembrolizumab |
Primary outcome
Objective Response Rate (ORR-PIT)
Time frame: 24 months
the proportion of patients with confirmed PIT-treated tumor response of complete response (CR) or partial response (PR) per RECIST 1.1, as assessed by central reviewer.
21 secondary outcomes
Duration of Response, for PIT-treated lesions
Time frame: 24 months
Assess effects on tumor response, for PIT-treated lesions
Time frame: 24 months
Assess effects on tumor response, Confirmed ORR for all lesions
Time frame: 24 months
Assess effects on tumor response, Disease control rate for all lesions
Time frame: 24 months
Assess effects on tumor response, DoR for all lesions
Time frame: 24 months
Assess effects on survival, PFS
Time frame: 24 months
Assess effects on survival, OS
Time frame: 24 months
Characterize safety and tolerability
Time frame: 24 months
Assess effects on quality of life, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Time frame: 12 months
Assess effects on quality of life, EORTC head and neck specific module (EORTC QLQ H&N 35)
Time frame: 12 months
Assess effects on quality of life, Functional Assessment of Cancer Therapy Head & Neck Cancer Symptom Index - 10 Item (FHNSI-10)
Time frame: 12 months
Characterize population pharmacokinetics of ASP-1929, AUC₀-ₜ (AUC, area under the concentration-time curve)
Time frame: 12 months
Characterize population pharmacokinetics of ASP-1929, AUC₀-₂₆
Time frame: 12 months
Characterize population pharmacokinetics of ASP-1929, AUC₀-∞
Time frame: 12 months
Characterize population pharmacokinetics of ASP-1929, AUCₐₗₗ
Time frame: 12 months
Characterize population pharmacokinetics of ASP-1929, Cₘₐₓ (maximum observed drug concentration)
Time frame: 12 months
Characterize population pharmacokinetics of ASP-1929, tₘₐₓ (time to maximal concentration)
Time frame: 12 months
Characterize population pharmacokinetics of ASP-1929, t₁/₂ (mean terminal elimination half-life)
Time frame: 12 months
Characterize population pharmacokinetics of ASP-1929, CL (volume of serum cleared of drug per unit time)
Time frame: 12 months
Characterize population pharmacokinetics of ASP-1929, Vₛₛ (volume of distribution at steady state following intravenous administration)
Time frame: 12 months
Characterize presence of anti-drug antibodies (ADA)
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites 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 and pembrolizumab in people with Head and Neck Cancer, run by Rakuten Medical, Inc. at 5 sites in Taiwan.
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 22 inclusion and 30 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: stopped early, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan. 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?
The study was stopped early (reason given: Business decision). 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?
Objective Response Rate (ORR-PIT) (time frame: 24 months). 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 4 Nov 2024.