Actively Recruiting
X-ray Psoralen Activated Cancer Therapy in Head and Neck, Breast, Sarcoma and Melanoma
Led by Immunolight, LLC · Updated on 2026-01-30
52
Participants Needed
4
Research Sites
377 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this Phase I trial for subjects with advanced head \& neck cancer, breast cancer, soft tissue sarcoma or melanoma all subjects will receive open label X-PACT treatment as a intra-tumoral injection. The primary objective will be to establish the safety of X-PACT when dosed with 5 intra-tumoral injections of the combination product (the phosphor device and methoxsalen sterile solution and subsequently exposing the tumor to X-ray energy) over a period of 6 weeks (on day D1, D3 and D5 of Week 1, on D1 of Week 2, and a booster on D1 of Week 6). After the week 8 tumor assessment subjects demonstrating stable disease, partial response or unconfirmed progression assessed by iRecist, will be eligible to receive two additional booster treatments 4-6 weeks apart. Treatment will be considered safe provided ≤ 2 out of 12 patients experience a dose-limiting toxicity (DLT) during the 6 weeks after the first intra-tumoral injection. Two expansion cohorts have been added to the study. One for TNBC and one for soft tissue sarcoma. 16 additional subjects will be added in each of the expansion cohorts.
CONDITIONS
Official Title
X-ray Psoralen Activated Cancer Therapy in Head and Neck, Breast, Sarcoma and Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent and HIPAA authorization
- Age 18 years or older
- ECOG Performance Status of 0 or 1
- Histologically or cytologically confirmed advanced solid tumors progressed after or intolerant to standard therapies
- Tumor is non-visceral, measurable by RECIST, accessible for injection, and superficial not exceeding 5 cm depth
- Tumor selected for injection offers potential local benefit and at least 80% is accessible for injection
- Patients with prior brain metastasis may be included if treatment completed at least 4 weeks prior, off corticosteroids for 2 weeks, and brain metastases are asymptomatic
- Radiation oncologist approves additional radiation via X-PACT considering prior radiation and toxicity risk
- All prior therapy toxicities resolved to Grade 1 or less
- Adequate organ function as defined for hematological, renal, hepatic, and coagulation parameters
- Females of childbearing potential have negative pregnancy test and agree to use highly effective contraception
- Male patients agree to use condoms during study and 28 days after
- Ability to understand and comply with study procedures
- Life expectancy of at least 4 months
- If prior curative radiation at treatment site, at least 6 month washout, resolved toxicity, and review of radiation history confirming safety
You will not qualify if you...
- Pregnant or breastfeeding
- Prior exposure to methoxsalen
- History of hypersensitivity to psoralen compounds or phosphor device components
- Light sensitive diseases or conditions including lupus, porphyria, xeroderma pigmentosum, albinism, aphakia
- Known HIV, hepatitis B or C infection
- Active infection requiring systemic therapy (except uncomplicated urinary tract infection per investigator discretion)
- Presence of other active primary malignancy requiring treatment except certain skin or in situ cancers or disease-free for 5 years
- Systemic anti-cancer treatment or investigational drug use within 28 days before treatment
- Impaired cardiac function or significant cardiac diseases including uncontrolled arrhythmias or hypertension, recent myocardial infarction, or severe heart failure
- Uncontrolled intercurrent illness or psychiatric/social conditions limiting compliance
- Tumor volume greater than 500 cc for soft tissue sarcoma or greater than 300 cc for other tumor types
- Current or planned corticosteroid use without required washout
- Active autoimmune disease requiring high-dose prednisone or biologic agents
- History of pancreatitis or unexplained elevated serum lipase
- For TNBC cohort, patients with HER2 ultra-low status are excluded
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Sibley Hospital - Johns Hopkins University
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
2
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
3
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
4
Prisma Health
Greenville, South Carolina, United States, 29605
Actively Recruiting
Research Team
S
Susan N McLaughlin, BSN
CONTACT
L
Lauren Wood, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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