An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGF… (NCT04305795) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors
United States23 participantsStarted 2020-12-21
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Overall Inclusion Criteria:
Provide written informed consent
• Cancers as follows:
Sub-study 1: Histologically or cytologically confirmed recurrent locally and/or metastatic head and neck squamous cell carcinoma with Combined Positive Score (CPS) ≥ 1 as determined by a CLIA certified and/or FDA approved test.
Note: A multi-disciplinary group (including a surgeon and radiation oncologist) must agree that the patient is not a candidate for locoregional therapy.
Sub-study 2: Histologically or cytologically confirmed locally advanced or metastatic cutaneous squamous cell carcinoma not amenable to definitive surgery or radiation.
Sub-study 3: Histologically or cytologically confirmed locally advanced or metastatic cutaneous squamous cell carcinoma not amendable to definitive surgery or radiation.
* At least one site of disease accessible to light illumination.
* Measurable disease by modified RECIST 1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* No prior systemic therapy administered in the recurrent and/or metastatic setting (with the exception of systemic therapy completed ≥ 6 months prior if given as part of multimodal treatment for locally advanced disease). (Sub-study 1 only).
* Patients must be actively receiving single-agent, systemic anti-PD1 therapy at the time of screening (Sub-study 3 only).
* Disease progression despite at least 2 months of anti-PD1 therapy at the time of screening. Progression must be confirmed by at least two …
What they're measuring
1
Characterize the safety and tolerability of ASP-1929 PIT treatment in combination with anti-PD1 therapy
Timeframe: 24 months
2
HNSCC: Assess the effect of ASP-1929 PIT treatment with anti-PD1 therapy on tumor response
Timeframe: 24 months
3
cuSCC: Assess the effect of ASP-1929 PIT treatment with anti-PD1 therapy on tumor response