Recurrent Head and Neck Squamous Cell CarcinomaPhase 1/2NCT04305795
An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors
A Phase 1/2 study testing 200 mg Pembrolizumab, 350 mg Cemiplimab and ASP-1929 PIT in people with Recurrent Head and Neck Squamous Cell Carcinoma and Metastatic Head-and-neck Squamous-cell Carcinoma, run by Rakuten Medical, Inc. at 7 sites in United States.
Trial summary
Open-label study using ASP-1929 photoimmunotherapy in combination with anti-PD1 therapy in patients with recurrent or metastatic head and neck and squamous cell cancer or advanced or metastatic cutaneous squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Head and Neck Squamous Cell Carcinoma, Metastatic Head-and-neck Squamous-cell Carcinoma, Locally Advanced Cutaneous Squamous Cell Carcinoma
- What is being tested?
- 200 mg Pembrolizumab, 350 mg Cemiplimab and ASP-1929 PIT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 7 sitesUnited States
- Study dates
- 21 Dec 2020to Jun 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
None listed.
Who cannot join
- Prior therapy with an anti-PD1 or anti-PD-L1 (Sub-study 1 only).
- Prior systemic therapy that is not intended as part of definitive treatment (eg, induction, concurrent, adjuvant, or neoadjuvant treatment) (Sub-studies 1 and 2 only).
- Systemic anti-PD-1 therapy prior to current course of definitive therapy (Sub-study 3 only).
- Prior systemic therapy given as definitive treatment (chemotherapy, EGFR inhibition). Patients with a history of prior chemoradiation are eligible (Sub-study 3 only).
- Radiation therapy (or other non-systemic therapy) within 4 weeks prior to study Day 1 or not fully recovered from adverse events due to a previously administered treatment
- 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 Cycle 1 Day 1.
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- Diagnosed and/or treated for additional malignancy within 2 years prior to study Day 1, except for, curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cervical and/or breast cancers.
- History of significant (≥ Grade 3) cetuximab infusion reactions.
- Prior allogeneic tissue/solid organ transplant.
- Known or active central nervous system metastases and/or carcinomatous meningitis.
- Active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
- Evidence of interstitial lung disease or current active, noninfectious pneumonitis.
- Active infection requiring systemic therapy.
- Known or active bacterial, viral, and fungal infection including tuberculosis, active Hepatitis B (eg, HBsAg reactive), or Hepatitis C (eg, RNA [qualitative] is detected)
- Known history of testing positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- Received a live vaccine within 30 days of study Day 1. 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.
- Requiring future examinations or treatments within 4 weeks after an ASP-1929 PIT treatment cycle exposing the patient to significant light (eg, eye examinations, surgical procedures, endoscopy) that is unrelated to the ASP-1929 PIT treatment
- Patients expecting to breastfeed during the study and through 120 days after the last dose of study treatment.
- Major surgery or significant traumatic injury ≤ 28 days before study day 1, or anticipation of the need for major surgery during the course of study treatment.
- Currently participating or participated in a study of an investigational agent and received study therapy (including RM-1929 or ASP-1929 PIT studies), or used an investigational device within 4 weeks of study Day 1.
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
University of Kentucky
Lexington, Kentucky, 40536
University of Miami Hospital and Clinics
Miami, Florida, 33136
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37203
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Providence Medical Center
Portland, Oregon, 97213
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Open-label study using ASP-1929 photoimmunotherapy in combination with anti-PD1 therapy in patients with recurrent or metastatic head and neck and squamous cell cancer or advanced or metastatic cutaneous squamous cell carcinoma.
Read the detailed description
This basket trial study has 3 sub-studies:
Sub-study 1 (181 HNSCC) will enroll patients with recurrent or metastatic (R/M) squamous cell cancer of the head and neck (HNSCC). HNSCC patients are required to have positive expression of programmed cell death ligand 1 (PD-L1) defined by Combined Positive Score (CPS) ≥1.
Sub-study 2 (181 cuSCC) will enroll patients with locally advanced or metastatic cutaneous squamous cell carcinoma (cuSCC).
Sub-study 3 (181 2LcuSCC) will enroll patients with locally advanced or metastatic cutaneous squamous cell carcinoma who have progressed on anti-PD-1 therapy.
Eligible patients will enroll in the applicable sub-study and receive ASP-1929 photoimmunotherapy (PIT) treatment in combination with an anti-PD-1 therapy for up to 24 months. During the treatment period, patients will undergo clinical assessments and be monitored for safety and tolerability and disease progression by modified RECIST 1.1 for overall response rate (ORR), progression-free survival (PFS), and duration of response (DOR).
Each sub-study is an open-label, single-arm study. For each sub-study, the primary objectives are to characterize the safety and tolerability of ASP-1929 PIT treatment in combination with anti-PD-1 treatment and to assess the effect of ASP-1929 PIT treatment with anti-PD1 therapy on tumor response.
- Conditions
- Recurrent Head and Neck Squamous Cell Carcinoma, Metastatic Head-and-neck Squamous-cell Carcinoma, Locally Advanced Cutaneous Squamous Cell Carcinoma, Metastatic Cutaneous Squamous Cell Carcinoma
- Being tested
- 200 mg Pembrolizumab, 350 mg Cemiplimab, ASP-1929 PIT
- Keywords
- Rakuten Medical, ASP-1929, HNSCC, CUSCC, head and neck, cutaneous, squamous cell carcinoma, photoimmunotherapy, PIT, skin, EGFR, Anti-PD1, Pembrolizumab, Cemiplimab
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
200 mg PembrolizumabBiological
every 3 weeks on Days 1 and 22 of each 6-week cycle for up to 24 months.
350 mg CemiplimabBiological
every 3 weeks on Days 1 and 22 of each 6-week cycle for up to 24 months.
ASP-1929 PITCombination product
ASP-1929 IV on Day 8 of each 6-week cycle for up to 24 months.
Photoimmunotherapy Light Treatment on Day 9 of each 6-week cycle for up to 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Sub-study 1- 1L HNSCC | Other | Recurrent locally advanced and/or metastatic head and neck squamous cell carcinoma Receives: Biological: 200 mg Pembrolizumab; Combination Product: ASP-1929 PIT |
| Sub-study 2- 1L cuSCC | Other | Locally advanced or metastatic cutaneous squamous cell carcinoma Receives: Biological: 350 mg Cemiplimab; Combination Product: ASP-1929 PIT |
| Sub-study 3- 2L cuSCC | Other | Locally advanced or metastatic cutaneous squamous cell carcinoma Receives: Biological: 350 mg Cemiplimab; Combination Product: ASP-1929 PIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the safety and tolerability of ASP-1929 PIT treatment in combination with anti-PD1 therapy
Treatment Emergent Adverse Events (TEAE) and Serious TEAE
Measured: 24 months
HNSCC: Assess the effect of ASP-1929 PIT treatment with anti-PD1 therapy on tumor response
Objective Response Rate (ORR) per modified RECIST 1.1, as assessed by investigator
Measured: 24 months
cuSCC: Assess the effect of ASP-1929 PIT treatment with anti-PD1 therapy on tumor response
Objective Response Rate (ORR) per modified RECIST 1.1, by central review of tumor imaging by photography and radiographic assessments
Measured: 24 months
Secondary outcomes (4)
Overall Survival (OS)
Assess the effect of ASP-1929 PIT treatment in combination with anti-PD1 therapy on survival
Measured: 24 months
Progression-free survival (PFS)
Assess the effect of ASP-1929 PIT treatment in combination with anti-PD1 therapy on survival
Measured: 24 months
Duration of Response (DOR)
Assess the effect of ASP-1929 PIT treatment in combination with anti-PD1 therapy on survival
Measured: 24 months
cuSCC: Objective Response Rate (ORR) per modified RECIST 1.1, as assessed by investigator review of tumor imaging by photography and radiographic assessments
Assess the effect of ASP-1929 PIT treatment in combination with anti-PD1 therapy on tumor response
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 posted12 Mar 2020
- Study start21 Dec 2020
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Head and Neck Squamous Cell CarcinomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rakuten Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Toshiaki Suzuki, MD, Study director, Rakuten Medical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305795
- Sponsor's protocol ID
- ASP-1929-181
- Status last verified
- Jun 2025
- First submitted
- 10 Mar 2020
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
Cognetti DM, Curry JM, Johnson J, Kwon M, Su SY, Civantos F, Olazagasti C, Valentino J, Arnold SM, Bell RB, Gibson MK, Mannion K, Van Abel KM, Price KA, Dong H, Thorne AH, Suzuki T, Gillenwater AM. Safety and Efficacy Findings From a Phase Ib/II Study of ASP-1929 Photoimmunotherapy With Pembrolizumab in Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma. Head Neck. 2026 Jan;48(1):160-174. doi: 10.1002/hed.70014. Epub 2025 Aug 25.
PubMed 40852760
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04305795
- Acronym / sponsor ID
- ASP-1929-181
- Conditions
- Recurrent Head and Neck Squamous Cell Carcinoma, Metastatic Head-and-neck Squamous-cell Carcinoma, Locally Advanced Cutaneous Squamous Cell Carcinoma, Metastatic Cutaneous Squamous Cell Carcinoma
- Keywords
- Rakuten Medical, ASP-1929, HNSCC, CUSCC, head and neck, cutaneous, squamous cell carcinoma, photoimmunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Rakuten Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 Mar 2020 (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.
Open-label study using ASP-1929 photoimmunotherapy in combination with anti-PD1 therapy in patients with recurrent or metastatic head and neck and squamous cell cancer or advanced or metastatic cutaneous squamous cell carcinoma.
Detailed description
This basket trial study has 3 sub-studies:
Sub-study 1 (181 HNSCC) will enroll patients with recurrent or metastatic (R/M) squamous cell cancer of the head and neck (HNSCC). HNSCC patients are required to have positive expression of programmed cell death ligand 1 (PD-L1) defined by Combined Positive Score (CPS) ≥1.
Sub-study 2 (181 cuSCC) will enroll patients with locally advanced or metastatic cutaneous squamous cell carcinoma (cuSCC).
Sub-study 3 (181 2LcuSCC) will enroll patients with locally advanced or metastatic cutaneous squamous cell carcinoma who have progressed on anti-PD-1 therapy.
Eligible patients will enroll in the applicable sub-study and receive ASP-1929 photoimmunotherapy (PIT) treatment in combination with an anti-PD-1 therapy for up to 24 months. During the treatment period, patients will undergo clinical assessments and be monitored for safety and tolerability and disease progression by modified RECIST 1.1 for overall response rate (ORR), progression-free survival (PFS), and duration of response (DOR).
Each sub-study is an open-label, single-arm study. For each sub-study, the primary objectives are to characterize the safety and tolerability of ASP-1929 PIT treatment in combination with anti-PD-1 treatment and to assess the effect of ASP-1929 PIT treatment with anti-PD1 therapy on tumor response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sub-study 1- 1L HNSCC | Other | Biological: 200 mg Pembrolizumab, Combination Product: ASP-1929 PITRecurrent locally advanced and/or metastatic head and neck squamous cell carcinoma |
| Sub-study 2- 1L cuSCC | Other | Biological: 350 mg Cemiplimab, Combination Product: ASP-1929 PITLocally advanced or metastatic cutaneous squamous cell carcinoma |
| Sub-study 3- 2L cuSCC | Other | Biological: 350 mg Cemiplimab, Combination Product: ASP-1929 PITLocally advanced or metastatic cutaneous squamous cell carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (21 listed)
- Prior therapy with an anti-PD1 or anti-PD-L1 (Sub-study 1 only).
- Prior systemic therapy that is not intended as part of definitive treatment (eg, induction, concurrent, adjuvant, or neoadjuvant treatment) (Sub-studies 1 and 2 only).
- Systemic anti-PD-1 therapy prior to current course of definitive therapy (Sub-study 3 only).
- Prior systemic therapy given as definitive treatment (chemotherapy, EGFR inhibition). Patients with a history of prior chemoradiation are eligible (Sub-study 3 only).
- Radiation therapy (or other non-systemic therapy) within 4 weeks prior to study Day 1 or not fully recovered from adverse events due to a previously administered treatment
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 |
|---|---|---|
| 200 mg Pembrolizumabevery 3 weeks on Days 1 and 22 of each 6-week cycle for up to 24 months. | Biological | Sub-study 1- 1L HNSCC |
| 350 mg Cemiplimabevery 3 weeks on Days 1 and 22 of each 6-week cycle for up to 24 months. | Biological | Sub-study 2- 1L cuSCC, Sub-study 3- 2L cuSCC |
| ASP-1929 PITASP-1929 IV on Day 8 of each 6-week cycle for up to 24 months. Photoimmunotherapy Light Treatment on Day 9 of each 6-week cycle for up to 24 months. | Combination product | Sub-study 1- 1L HNSCC, Sub-study 2- 1L cuSCC, Sub-study 3- 2L cuSCC |
Primary outcome
Characterize the safety and tolerability of ASP-1929 PIT treatment in combination with anti-PD1 therapy
Time frame: 24 months
Treatment Emergent Adverse Events (TEAE) and Serious TEAE
HNSCC: Assess the effect of ASP-1929 PIT treatment with anti-PD1 therapy on tumor response
Time frame: 24 months
Objective Response Rate (ORR) per modified RECIST 1.1, as assessed by investigator
cuSCC: Assess the effect of ASP-1929 PIT treatment with anti-PD1 therapy on tumor response
Time frame: 24 months
Objective Response Rate (ORR) per modified RECIST 1.1, by central review of tumor imaging by photography and radiographic assessments
4 secondary outcomes
Overall Survival (OS)
Time frame: 24 months
Progression-free survival (PFS)
Time frame: 24 months
Duration of Response (DOR)
Time frame: 24 months
cuSCC: Objective Response Rate (ORR) per modified RECIST 1.1, as assessed by investigator review of tumor imaging by photography and radiographic assessments
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Derived from this study: PubMed 40852760Cognetti DM, Curry JM, Johnson J, Kwon M, Su SY, Civantos F, Olazagasti C, Valentino J, Arnold SM, Bell RB, Gibson MK, Mannion K, Van Abel KM, Price KA, Dong H, Thorne AH, Suzuki T, Gillenwater AM. Safety and Efficacy Findings From a Phase Ib/II Study of ASP-1929 Photoimmunotherapy With Pembrolizumab in Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma. Head Neck. 2026 Jan;48(1):160-174. doi: 10.1002/hed.70014. Epub 2025 Aug 25.
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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.
Toshiaki Suzuki, MD study director
Rakuten Medical, Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 200 mg Pembrolizumab, 350 mg Cemiplimab and ASP-1929 PIT in people with Recurrent Head and Neck Squamous Cell Carcinoma and Metastatic Head-and-neck Squamous-cell Carcinoma, run by Rakuten Medical, Inc. at 7 sites 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 0 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
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?
Characterize the safety and tolerability of ASP-1929 PIT treatment in combination with anti-PD1 therapy (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04305795, which also lists 1 linked publication.
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 19 Jun 2025.