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X-PACT for Advanced Head & Neck, Breast, Sarcoma, and Melanoma Cancers

This study is testing a new treatment called X-PACT for people with advanced head and neck cancer, breast cancer, soft tissue sarcoma, or melanoma. X-PACT involves injecting a solution called methoxsalen directly into the tumor, followed by exposure to X-ray energy. The main goal of this Phase I study is to find out if X-PACT is safe when given as five injections over six weeks. The study plans to enroll 52 participants. If you have stable disease, partial response, or unconfirmed progression after eight weeks, you might be eligible for additional booster treatments. The study will consider the treatment safe if only a small number of patients experience serious side effects during the first six weeks.

Study design
This is a Phase I, open-label study, meaning both you and the study team will know which treatment you are receiving. It plans to enroll 52 participants.
What's involved
You would receive five injections of X-PACT over six weeks, with potential for additional booster treatments. You will have scans at baseline, day 8, and week 7, plus other standard care visits.
Compensation
Not stated in the trial record.
Follow-up
You will be followed until you are lost to follow-up, refuse further follow-up, or until death.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04389281

X-ray Psoralen Activated Cancer Therapy in Head and Neck, Breast, Sarcoma and Melanoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
Immunolight, LLC
~52 participants
Updated 2026-01-30 on ClinicalTrials.gov
What's tested:X-PACT

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-Limiting Toxicity (DLT)
Measured over First 6 weeks

Conditions

Advanced Solid Tumor Cancer

Explore related trials

Breast CarcinomaMalignant Head and Neck NeoplasmMelanomaSoft Tissue SarcomaSolid Neoplasm

Where it's being run

4 sites across 3 states
North Carolina2
District of Columbia1
South Carolina1

Study leadership

  • William Eward, MD · PRINCIPAL_INVESTIGATOR · Duke University

Who to contact

Susan N McLaughlin, BSN
[email protected]
7048776363
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation
intravaginal
transdermal
progestogen-only hormonal contraception associated with inhibition of ovulation
injectable
implantable
intrauterine device (IUD)
intrauterine hormone-releasing system (IUS)
vasectomised partner
sexual abstinence
There is at least a 6 month wash out period from the last date radiation was received to assess for radiation toxicity.
If there was previous radiation toxicity at the proposed site of X-PACT, the toxicity resolved at least three months ago and the site did not involve a major organ.
The site investigator in addition to the radiation oncologist (as a part of criterion #6) has fully reviewed the subject's radiation history, has examined the area for radiation toxicity and assessed the cumulative dose for either 5 or 7 X-PACT treatments and determined they will not pose additional risk for radiation toxicity or re-activate any other previous toxicity.
For the TNBC Cohort, participants must have either unresectable, locally advanced, relapsed, refractory or metastatic disease with HER2 negative/low ER/PR status (\<10%) or HER2 negative/ER/PR negative. Patients determined to be HER2 ultra-low will not be enrolled. Furthermore, participants must have received at least one prior treatment (best medical treatment for cancer stage, PDL-1 status, BRCA 1 or 2 status and general health status) as per Figure 26-1 (see Protocol for schematic . Participants who are intolerant or refuse best medical care would also be eligible.
For the STS Cohort, participants must have received at least one prior treatment (best medical treatment recommended for the participants sub-type) for unresectable, locally advanced, relapsed, refractory or metastatic disease. Participants who are intolerant to or have refused best medical treatment for their subtype will also be eligible. Best medical treatment includes: surgery, radiation, chemotherapy (including doxorubicin, Trabectedin), gene therapy, targeted therapy (pazopanib) or antibody-drug conjugates.
14 It is preferable to select tumors that have not been previously radiated, but if other options are not available and the tumor selected is in a field which received curative-intent radiation, then the participant may only be enrolled with the following provisions satisfied.
There is at least a 6 month wash out period from the last date radiation was received to assess for radiation toxicity.
If there was previous radiation toxicity at the proposed site of X-PACT, the toxicity resolved at least three months ago and the site did not involve a major organ.
The site investigator in addition to the radiation oncologist (as a part of criterion #6) has fully reviewed the subject's radiation history, has examined the area for radiation toxicity, has assessed the cumulative dose for total X-PACT treatments and determined they will not pose additional risk for radiation toxicity or re-activate any other previous toxicity.

What this trial measures

  • Dose-Limiting Toxicity (DLT)First 6 weeks

    The primary objective will be to establish the safety of X-PACT when dosed at the schedule described above, with X-PACT considered safe provided ≤ 2 out of 12 patients experience a dose-limiting toxicity (DLT) during the 6 weeks after the first intra-tumoral injection.