ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03769506 |
Recruitment Status :
Recruiting
First Posted : December 7, 2018
Last Update Posted : April 1, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Head and Neck Cancer | Combination Product: ASP-1929 Photoimmunotherapy Drug: Physician's Choice SOC | Phase 3 |
The study will have an Experimental Arm and a Control Arm.
Experimental Arm:
Patients may receive repeated ASP-1929 PIT interventions for a period of up to 12 months after randomization until the patient has complete remission, progressive disease that is no longer amendable to study treatment, patient experiences intolerable side effects, or patient discontinues study treatment.
Control Arm:
Patients may be treated with physician's choice SOC until the patient has progressive disease, patient experiences intolerable side effects, or patient discontinues study treatment.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 275 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 Photoimmunotherapy Versus Physician's Choice Standard of Care for the Treatment of Locoregional, Recurrent Head and Neck Squamous Cell Carcinoma 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 |
Actual Study Start Date : | May 9, 2019 |
Estimated Primary Completion Date : | September 30, 2024 |
Estimated Study Completion Date : | December 30, 2024 |

Arm | Intervention/treatment |
---|---|
Active Comparator: ASP-1929 Photoimmunotherapy
Use of ASP1929 PIT therapy
|
Combination Product: ASP-1929 Photoimmunotherapy
Use of ASP-1929 PIT therapy |
Active Comparator: Physician's Choice SOC
docetaxel, cetuximab, methotrexate, paclitaxel
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Drug: Physician's Choice SOC
docetaxel, cetuximab, methotrexate, or paclitaxel |
- Progression-Free Survival [ Time Frame: 24 months ]Time to progression of disease
- Overall survival [ Time Frame: 24 months ]Duration of survival between the two treatment arms

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Overall Inclusion Criteria:
- Have a histologically confirmed locoregional persistent, recurrent or second primary squamous cell carcinoma of the head and neck, not amenable to curative treatment
- 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
- Have completed prior curative radiation therapy for treatment of their head and neck region
- Have locoregional head and neck tumor site(s) that are all accessible to illumination
- Have target tumors that are clearly measurable by contract enhanced CT scan
- Have a life expectancy of > 6 months, based on Investigator judgment
- Male participants must agree to use contraception during the treatment period and for at least 6 months after the last ASP-1929 infusion
- Female patients of childbearing potential must not be pregnant or breastfeeding and agrees to follow the contraceptive guidance 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
- Have an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
Overall Exclusion Criteria:
- Have a history of significant (> Grade 3) cetuximab infusion reactions
- Have been treated with prior systematic chemotherapy or targeted small molecule therapy or radiation therapy within 2 weeks of trial Day 1 or not recovered from adverse events due to a previously administered agent
- Have been treated with an anticancer monoclonal antibody therapy within 4 of trial Day 1 or have not recovered from adverse events due to previously administered agent
- Have been treated with an investigational agent or intervention within 4 weeks of trial Day 1 or have not recovered from adverse events, due to previously administered agent or intervention
- Have a present history of distant metastatic disease (M1)
- Have an active undergoing treatment or have a diagnosis of an active cancer other than nonmelanoma skin cancer or HNSCC
- Have a tumor in enhanced CT or MRI scan invading a major blood vessel, unless the vessel has been embolized, stented or surgically ligated to prevent potential bleeding from a blood vessel
- Have impaired hepatic function
- Have impaired renal function
- Have 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
- Have been previously treated or randomized to any trial using ASP-1929 or RM-1929 PIT as the study treatment

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769506
Contact: Sumera Raoof, MD, MPH | +1 858-925-5619 | clinicaltrialinfo@rakuten-med.com |

Study Director: | Sarah Arron, MD | Rakuten Medical, Inc. |
Responsible Party: | Rakuten Medical, Inc. |
ClinicalTrials.gov Identifier: | NCT03769506 |
Other Study ID Numbers: |
ASP-1929-301 |
First Posted: | December 7, 2018 Key Record Dates |
Last Update Posted: | April 1, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | Yes |
Rakuten Medical ASP-1929 PIT Photoimmunotherapy |
HNC HNSCC Head and neck |
Head and Neck Neoplasms Neoplasms by Site Neoplasms |