ASP-1929 Photoimmunotherapy Combined With Pembrolizumab in Patients With Recurrent Head and Neck Cancer, With or Without Metastases

NCT05265013 | Terminated Phase 2 FDA Drug

• 1 other identifier: ASP-1929-218
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 5

Brief 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

Conditions

Head and Neck Cancer

Keywords

Rakuten Medical; ASP-1929; PIT; Photoimmunotherapy; HNC; HNSCC; Head and neck; pembrolizumab

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (21)

• Duration of Response, for PIT-treated lesions

  24 months

• Assess effects on tumor response, for PIT-treated lesions

  24 months

• Assess effects on tumor response, Confirmed ORR for all lesions

  24 months

• Assess effects on tumor response, Disease control rate for all lesions

  24 months

• Assess effects on tumor response, DoR for all lesions

  24 months

Study Arms (1)

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.

Combination Product: ASP-1929 Photoimmunotherapy; Biological: pembrolizumab

Interventions

ASP-1929 Photoimmunotherapy COMBINATION_PRODUCT

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

Also known as: cetuximab sarotalocan, PIT690 Laser System

ASP-1929 Photoimmunotherapy Combined With Pembrolizumab

pembrolizumab BIOLOGICAL

200 mg every three weeks on days 1 and 22 of each 6-week cycle, 30 minute IV infusion

Also known as: Keytruda

ASP-1929 Photoimmunotherapy Combined With Pembrolizumab

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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):

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Rakuten Medical, Inc.: lead

Study Sites (5)

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: ASP-1929 Photoimmunotherapy Combined With Pembrolizumab

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: March 3, 2022
• Study Start: April 19, 2022
• Primary Completion: November 20, 2023
• Study Completion: March 29, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (5)