Study of the combination of the drug ASP-1929 and light illumination with the device PIT690 laser system in addition with pembrolizumab versus Standard of Care in the treatment of locoregional recurrent squamous cell carcinoma of the head and neck with no distant metastases

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Rakuten Medical Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-04-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Rakuten Medical, Inc., USA

External identifiers

EU CT number

2025-523017-28-00

ClinicalTrials.gov

NCT06699212

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Efficacy, Pharmacokinetic, Therapy, Dose response, Safety

Assess effect on survival

Secondary objectives 5

1. Assess effect on tumor response including disease progression
2. Assess additional effects on tumor response including durability of response
3. Characterize safety and tolerability
4. Assess effects on quality of life
5. Characterize population pharmacokinetics (PK) of ASP-1929 and presence of anti-drug antibodies (ADA)

Conditions and MedDRA coding

Locoregional Recurrence of Squamous Cell Carcinoma of the Head and Neck (HNSCC)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Provision of written informed consent.
2. Male or female patients aged ≥18 years at the time of informed consent.
3. Histologically or cytologically confirmed squamous cell carcinoma of the primary site in the head or neck region (according to the American Joint Committee on Cancer [AJCC] classification), excluding nasopharyngeal carcinoma or cutaneous squamous cell carcinoma (cSCC). For confirmation of squamous cell carcinoma diagnosis, a pathology report must be provided for both the primary tumour and recurrence.
4. In the investigator’s opinion, patients must be eligible for standard first-line therapy with pembrolizumab ± chemotherapy for recurrent head and neck cancer.
5. No documented cases of distant metastases (M1 stage according to AJCC 8th edition)
6. Presence of at least one lesion suitable for illumination with PIT (photoimmunotherapy) and measurable according to RECIST 1.1 criteria (by investigator’s assessment). Lesions in previously illuminated areas are considered measurable if progression is documented. • Lesions suitable for PIT illumination must be located in an area accessible to superficial or interstitial illumination. • These may be superficial lesions (for superficial illumination) or deep lesions (for interstitial illumination). • Lesions not suitable for PIT illumination include tumours requiring fibre insertion through bone (except tumours in paranasal sinuses), or tumours directly adjacent to / involving arteries, major veins, the orbit/eyeball, dura mater, or brain (including perineural invasion to the skull base).
7. Patients who have not previously received anti–PD-1 or anti–PD-L1 therapy.
8. CPS greater or equal to 1, determined locally using an FDA-approved test.

Exclusion criteria 7

1. Diagnosis and/or treatment of another malignancy within 2 years prior to randomisation, except for diseases with minimal risk of metastasis or death (e.g., adequately treated cervical carcinoma in situ, basal cell carcinoma of the skin, localized prostate cancer, or ductal carcinoma in situ). Patients with a history of another malignancy that was completely surgically removed and shows no evidence of recurrence may be eligible after consultation with the sponsor’s medical monitor.
2. Patients with a history of significant (grade ≥3) infusion reactions to cetuximab.
3. Prior allogeneic transplantation of tissues/solid organs.
4. Presence of or active metastases to the central nervous system and/or carcinomatous meningitis.
5. Estimated life expectancy less than 3 months.
6. Active autoimmune disease requiring systemic treatment within the past 2 years (i.e., use of immunosuppressive therapy including corticosteroids or disease-modifying agents). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment.
7. Evidence of interstitial lung disease or active non-infectious pneumonitis.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Overall Survival (OS): OS is defined as the time from randomisation to death from any cause.

Secondary endpoints 1

1. Key Secondary: • Complete Response Rate: CRR is defined as the proportion of patients with best overall response of confirmed CR per modified RECIST 1.1 as assessed by central reviewer. • Objective Response Rate: ORR is defined as the proportion of patients with best overall response of confirmed CR or confirmed PR per modified RECIST 1.1 as assessed by central reviewer.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 6

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rakuten Medical Inc.

Sponsor organisation

Rakuten Medical Inc.

Address

6885 Flanders Drive Suite 100

City

San Diego

Postcode

92121-2933

Country

United States

Scientific contact point

Organisation

Rakuten Medical Inc.

Contact name

Rakuten Medical Study Team

Public contact point

Organisation

Rakuten Medical Inc.

Contact name

Rakuten Medical Study Team

Third parties 11

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 37 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications