Advanced Solid Tumor CancerPhase 1NCT04389281
X-ray Psoralen Activated Cancer Therapy in Head and Neck, Breast, Sarcoma and Melanoma
A Phase 1 study testing X-PACT in people with Advanced Solid Tumor Cancer, run by Immunolight, LLC at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor Cancer
- What is being tested?
- X-PACT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Dec 2021to Mar 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent
- ECOG Performance Status of ≤ 1
- Subjects with histologically or cytologically confirmed advanced solid tumors which have progressed after standard therapy(ies), intolerant to standard therapy, refused standard therapy or for which no standard therapy(ies) exist. Furthermore, the tumor targeted for injections should be:
- A non-visceral tumor, a metastatic lymph node, a metastasis from a visceral solid tumor provided the lesion is extravisceral, or a cutaneous tumor. Visceral tumors will not be treated.
- The tumor must be measurable as per RECIST criteria.
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- The tumor should be directly accessible for injection or accessible with the use of ultrasound/CT guidance.
- The tumor identified for injection should be selected so local control could potentially provide benefit to the patient.
- 80% of the tumor must be accessible for injection with X-PACT (assessed by the treating physician)
- The tumor must be superficial and not exceed a depth of 5 cm.
- Eye or brain tumors will not be treated.
- A patient with prior brain metastasis may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to day 1 of treatment, have been off of corticosteroids for ≥ 2 weeks, and brain metastases are asymptomatic.
- The study site Radiation Oncologist Investigator/sub-investigator has determined additiional radiation delivered via X-PACT is appropriate given patient's prior radiation exposure. The treating Radiation Oncologist will review all prior radiation received to the proposed site of X-PACT treatment and assess the potential for unacceptable toxicity to the site or local organ(s) using QUANTEC.
- All toxicities from prior therapy should be ≤Grade 1 before start of study treatment. All radiation associated toxicities must have completely resolved to be considered for inclusion into the study.
- Demonstrate adequate organ function as defined in the table below:
- Hematological:
- White blood cell (WBC) ≥ 3 x 109/L Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L Platelet Count ≥ 100 x 109/L Hemoglobin (Hgb) ≥ 8 g/dL2
- Renal:
- Serum creatinine OR Creatinine clearance ≤ 1.5 x upper limit of normal (ULN) OR, in patients with a serum creatinine 1.5 x ULN, ≥ 60 mL/min as measured by a 24-hour urine collection or estimated by the Cockcroft and Gault formula
- Hepatic:
- Total bilirubin ≤ 1.5 × ULN (in patients with known Gilbert Syndrome a total bilirubin ≤3.0× ULN with direct bilirubin ≤1.5 X ULN) Aspartate aminotransferase (AST) ≤ 2.5 × ULN (or ≤ 5 if liver metastases are present) Alanine aminotransferase (ALT) ≤ 2.5 × ULN (or ≤ 5 if liver metastases are present)
- Coagulation:
- International Normalized Ratio (INR) ≤ 1.5
- Females of childbearing potential (FCBP) must have a negative serum pregnancy test within 3 days prior to day 1 of treatment. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are postmenopausal (at least 12 consecutive months with no menses without an alternative medical cause).
- FCBP must be willing to use a highly effective contraceptive method (i.e., achieves a failure rate of <1% per year when used consistently and correctly) from the time of informed consent until 28 days after treatment discontinuation. Contraceptive methods with low user dependency are preferable but not required (see table below, adapted from:
- http://www.hma.eu/fileadmin/dateien/HumanMedicines/01-AboutHMA/WorkingGroups/CTFG/201409HMACTFGContraception.pdf)
- Highly Effective Birth Control Methods:
- combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation
- o oral
- intravaginal
- transdermal
- progestogen-only hormonal contraception associated with inhibition of ovulation
- o oral
- injectable
- implantable
- intrauterine device (IUD)
- intrauterine hormone-releasing system (IUS)
- vasectomised partner
- sexual abstinence
- 11. Male patients must be willing to use condoms from the time of informed consent until 28 days after treatment discontinuation. For a non-pregnant FCBP partner, contraception recommendations should also be considered.
- 12. As determined by the enrolling physician, ability of the patient to understand and comply with study procedures for the entire length of the study
- 13. Patient is expected to have a life expectancy of at least 4 months
- 14. If the proposed site of treatment with X-PACT had prior exposure to curative-intent radiation, the patient may be entered into the trial 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 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.
Who cannot join
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study.)
- Prior exposure to methoxsalen
- History of any of the following:
- Idiosyncratic or hypersensitivity reactions to any psoralen compounds or any of their excipients
- Light sensitive disease state
- Disease associated with photosensitivity including lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum and albinism
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- Aphakia
- History of idiosyncratic or hypersensitivity reactions to any of the phosphor device components
- Known diagnosis of human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection (NOTE: testing not required)
- Active infection requiring systemic therapy (NOTE: at discretion of investigator, patients with uncomplicated urinary tract infections may be eligible.)
- Has a known additional other primary malignancy that is active and/or progressive requiring treatment; exceptions include basal cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the patient has been disease-free for at least five years.
- Systemic anti-cancer treatment within 28 days (or 5 half-lives, whichever is shorter) prior to day 1 of treatment
- Treatment with any investigational drug within 5 half-lives or 28 days, whichever is shorter (or if half-life is unknown, within 28 days) prior to day 1 of treatment
- Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded)
- Uncontrolled hypertension (systolic BP > 170 mmHg or diastolic BP > 105 mmHg at screening) despite two concomitant antihypertensive therapies.
- Acute myocardial infarction or unstable angina ≤ 6 months prior to day 1 of treatment
- New York Heart Association Class III or IV congestive heart failure (
- Other uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements as determined by the investigator.
- The tumor identified for treatment has a volume greater than 500 cc (Soft Tissue Sarcoma only). All other tumor types may have a maximum volume of 300 cc
- Receiving or planned use of corticosteroids. Subjects will require a one-week washout period from prior corticosteroid use. Inhaled or topical steroids are permitted.
- Subjects with active autoimmune disease requiring 10 mg or greater of prednisone and/or biologic agents.
- Subjects with a history of pancreatitis or elevated baseline serum lipase without otherwise specified etiology.
- For the Expansion Cohorts, the inclusion criteria remain the same except for Inclusion Criteria #4 and #14 and which reads:
- 4. Subjects with histologically and/or cytologically confirmed, inoperable locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC Cohort) or advanced, metastatic or relapsed soft tissue sarcoma (STS Cohort). Furthermore, the tumor targeted for injections should be:
- A non-visceral tumor, a metastatic lymph node, a metastasis from a visceral solid tumor provided the lesion is extravisceral, or a cutaneous tumor. Visceral tumors will not be treated.
- The tumor must be measurable as per RECIST criteria, at least 1 cm for masses and 1.5 cm for lymph nodes.
- The tumor should be directly accessible for injection or accessible with the use of ultrasound/CT guidance.
- 80% of the tumor must be accessible for injection with X-PACT (assessed by the treating physician)
- Up to 4 target lesions may be selected for injection in up to two radiation fields, but the radiation fields may not overlap, however, the total phosphors delivered may not exceed 840 mg for each treatment day (e.g. investigators may elect to treat only one very large tumor, two medium tumors, one large and one small tumor, or 4 very small tumors to ensure the total phosphors limit per treatment). Selected lesions must represent at least 50% of the tumor load by investigator determination.
- 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.
- For the TNBC cohort the following exclusion criteria has been added:
- 17. For the TNBC Cohort, patients determined to be HER2 ultra-low.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lauren Wood, MD contact
United States4 sites, 4 recruiting
- Recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28204
Heather Neagle
Shahab Babakoohi, MD
- Recruiting
Duke University
Durham, North Carolina, 27710
Betsy Sachs
Willam Eward, MD
- Recruiting
Prisma Health
Greenville, South Carolina, 29605
William J Edenfield, MD
- Recruiting
Sibley Hospital - Johns Hopkins University
Washington D.C., District of Columbia, 20016
Panagis Galiatsatos, MD
About this study
Official title: Phase 1 Study of X-PACT (X-ray Psoralen Activated Cancer Therapy) for Intra-tumoral Injection of Superficial Tumors in Patients With Advanced Head and Neck Cancer, Breast Cancer, Soft Tissue Sarcoma or Melanoma
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.
Read the detailed description
The primary endpoint 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. Part C has been added to the study to allow patients who respond to treatment to receive an additional 12 treatments over 12 months. In part C, up to two tumors in up to two radiation fields may be treated. 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. Subjects will have staging scans at baseline, day 8, week 7 and as per standard of care during the optional treatment and follow up study periods. Patients will be followed until they are lost to follow-up, refuse further follow-up or until death.
Subjects in each of the expansion cohorts will be randomized to receive either 10 or 14 X-PACT treatments.
- Conditions
- Advanced Solid Tumor Cancer
- Being tested
- X-PACT
- Keywords
- Advanced Head & Neck Cancer, Advanced Breast Cancer, Advanced Melanoma, Advanced Soft Tissue Sarcoma, Advanced Solid Tumor
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-PACTCombination product
X-PACT is comprised of a phosphor device, the drug methoxsalen sterile solution and X-ray energy. The dose of methoxsalen sterile solution per injection will vary per patient and will remained fixed across injections within each patient as it is based on the applicable tumor volume at baseline. Immediately after each injection of the combination product, patients will be exposed to an X-ray beam delivered via a LINAC (and thus targeted at the tumor) at a fixed dose to activate the combination product.
| Study group | Role | What they receive |
|---|---|---|
| Solid Tumor Cohort | Experimental | Single Arm (Part I): Open Label Solid Tumor Study: single arm consisting of a six-week treatment period with X-PACT (phosphor device and methoxsalen sterile solution and subsequently exposing the tumor to X-ray energy) administered as an intra-tumoral injection. Up to 7 X-PACT treatments will be administered at 1x phosphors and 1.35 Gy Radiation Receives: Combination Product: X-PACT |
| Expansion Cohort - 10 Treatments, 1x Phosphors, 2 Gy Radiation | Active comparator | Randomized (Part II) - 4 patient Soft Tissue Sarcoma cohort and a 4 patient Triple Negative Breast Cancer cohort.
Arm 1 - 10 X-PACT Treatments, 1x phosphors/tumor volume, 2.0 Gy Radiation Receives: Combination Product: X-PACT |
| Expansion Cohort - 14 Treatments, 1x Phosphors, 2 Gy Radiation | Active comparator | Randomized (Part II) - 4 patient Soft Tissue Sarcoma cohort and a 4 patient Triple Negative Breast Cancer cohort.
Arm 2 - 14 X-PACT Treatments, 1x phosphors/tumor volume, 2.0 Gy Radiation Receives: Combination Product: X-PACT |
| Expansion Cohort - 10 Treatments, 2x Phosphors, 1.35 Gy Radiation | Active comparator | Randomized (Part II) - 4 patient Soft Tissue Sarcoma cohort and a 4 patient Triple Negative Breast Cancer cohort.
Arm 3 - 10 X-PACT Treatments, 2x phosphors/tumor volume, 1.35 Gy Radiation Receives: Combination Product: X-PACT |
| Expansion Cohort - 14 Treatments, 2x Phosphors, 1.35 Gy Radiation | Active comparator | Randomized (Part II) - 4 patient Soft Tissue Sarcoma cohort and a 4 patient Triple Negative Breast Cancer cohort.
Arm 4 - 14 X-PACT Treatments, 2x phosphors/tumor volume, 1.35 Gy Radiation Receives: Combination Product: X-PACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity (DLT)
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.
Measured: First 6 weeks
Secondary outcomes (7)
Evaluate Local Response Rate (LRR)
Evaluate local response rate by assessing treated tumor volume pre and post treatment
Measured: After first 6 weeks of treatment
Evaluate Durability of Response
Evaluate duration of local control
Measured: Post first 6 treatments to 2 years post last treatment
Evaluate Objective Response Rate (ORR)
Evaluate the proportion of patients who have a partial or complete response to therapy.
Measured: After first 6 weeks of treatment
Evaluate Progression Free Survival
Evaluate the length of time during and after the treatment that the subject lives with the disease but it does not get worse.
Measured: Post first 6 treatments to 2 years post last treatment
Evaluate Overall Survival
Evaluate the length of time subjects stay alive from the date of first treatment.
Measured: Post first 6 treatments to 2 years post last treatment
PK Profile (C max) of Methoxsalen
Establish C max of methoxsalen when given as an intra-tumoral injection
Measured: First 6 weeks of study
PK Profile (AUC) of Methoxsalen
Establish AUC of methoxsalen when given as an intra-tumoral injection
Measured: First 6 weeks of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start8 Dec 2021
- Primary completionSep 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumor CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part One - Single Group, Open Label - Solid Tumor Part Two - Randomized to either 10 or 14 X-PACT treatments with either 1.35 or 2.0 Gy of radiation and to active the study drug and single or double phosphor administration
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immunolight, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Eward, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389281
- Sponsor's protocol ID
- X-PACT 101
- Status last verified
- Jan 2026
- First submitted
- 4 May 2020
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported after deidentification for researchers who provide a methodologically sound proposal.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of X-PACT (X-ray Psoralen Activated Cancer Therapy) for Intra-tumoral Injection of Superficial Tumors in Patients With Advanced Head and Neck Cancer, Breast Cancer, Soft Tissue Sarcoma or Melanoma
- ClinicalTrials.gov ID
- NCT04389281
- Acronym / sponsor ID
- X-PACT 101
- Conditions
- Advanced Solid Tumor Cancer
- Keywords
- Advanced Head & Neck Cancer, Advanced Breast Cancer, Advanced Melanoma, Advanced Soft Tissue Sarcoma, Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Immunolight, LLCIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 15 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary endpoint 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. Part C has been added to the study to allow patients who respond to treatment to receive an additional 12 treatments over 12 months. In part C, up to two tumors in up to two radiation fields may be treated. 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. Subjects will have staging scans at baseline, day 8, week 7 and as per standard of care during the optional treatment and follow up study periods. Patients will be followed until they are lost to follow-up, refuse further follow-up or until death.
Subjects in each of the expansion cohorts will be randomized to receive either 10 or 14 X-PACT treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Part One - Single Group, Open Label - Solid Tumor Part Two - Randomized to either 10 or 14 X-PACT treatments with either 1.35 or 2.0 Gy of radiation and to active the study drug and single or double phosphor administration
| Arm | Type | Receives |
|---|---|---|
| Solid Tumor Cohort | Experimental | Combination Product: X-PACTSingle Arm (Part I): Open Label Solid Tumor Study: single arm consisting of a six-week treatment period with X-PACT (phosphor device and methoxsalen sterile solution and subsequently exposing the tumor to X-ray energy) administered as an intra-tumoral injection. Up to 7 X-PACT treatments will be administered at 1x phosphors and 1.35 Gy Radiation |
| Expansion Cohort - 10 Treatments, 1x Phosphors, 2 Gy Radiation | Active comparator | Combination Product: X-PACTRandomized (Part II) - 4 patient Soft Tissue Sarcoma cohort and a 4 patient Triple Negative Breast Cancer cohort. Arm 1 - 10 X-PACT Treatments, 1x phosphors/tumor volume, 2.0 Gy Radiation |
| Expansion Cohort - 14 Treatments, 1x Phosphors, 2 Gy Radiation | Active comparator | Combination Product: X-PACTRandomized (Part II) - 4 patient Soft Tissue Sarcoma cohort and a 4 patient Triple Negative Breast Cancer cohort. Arm 2 - 14 X-PACT Treatments, 1x phosphors/tumor volume, 2.0 Gy Radiation |
| Expansion Cohort - 10 Treatments, 2x Phosphors, 1.35 Gy Radiation | Active comparator | Combination Product: X-PACTRandomized (Part II) - 4 patient Soft Tissue Sarcoma cohort and a 4 patient Triple Negative Breast Cancer cohort. Arm 3 - 10 X-PACT Treatments, 2x phosphors/tumor volume, 1.35 Gy Radiation |
| Expansion Cohort - 14 Treatments, 2x Phosphors, 1.35 Gy Radiation | Active comparator | Combination Product: X-PACTRandomized (Part II) - 4 patient Soft Tissue Sarcoma cohort and a 4 patient Triple Negative Breast Cancer cohort. Arm 4 - 14 X-PACT Treatments, 2x phosphors/tumor volume, 1.35 Gy Radiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (46 listed)
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent
- ECOG Performance Status of ≤ 1
- Subjects with histologically or cytologically confirmed advanced solid tumors which have progressed after standard therapy(ies), intolerant to standard therapy, refused standard therapy or for which no standard therapy(ies) exist. Furthermore, the tumor targeted for injections should be:
- A patient with prior brain metastasis may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to day 1 of treatment, have been off of corticosteroids for ≥ 2 weeks, and brain metastases are asymptomatic.
Key exclusion criteria (38 listed)
- For the Expansion Cohorts, the inclusion criteria remain the same except for Inclusion Criteria #4 and #14 and which reads:
- 4. Subjects with histologically and/or cytologically confirmed, inoperable locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC Cohort) or advanced, metastatic or relapsed soft tissue sarcoma (STS Cohort). Furthermore, the tumor targeted for injections should be:
- A non-visceral tumor, a metastatic lymph node, a metastasis from a visceral solid tumor provided the lesion is extravisceral, or a cutaneous tumor. Visceral tumors will not be treated.
- The tumor must be measurable as per RECIST criteria, at least 1 cm for masses and 1.5 cm for lymph nodes.
- The tumor should be directly accessible for injection or accessible with the use of ultrasound/CT guidance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| X-PACTX-PACT is comprised of a phosphor device, the drug methoxsalen sterile solution and X-ray energy. The dose of methoxsalen sterile solution per injection will vary per patient and will remained fixed across injections within each patient as it is based on the applicable tumor volume at baseline. Immediately after each injection of the combination product, patients will be exposed to an X-ray beam delivered via a LINAC (and thus targeted at the tumor) at a fixed dose to activate the combination product. | Combination product | Expansion Cohort - 10 Treatments, 1x Phosphors, 2 Gy Radiation, Expansion Cohort - 10 Treatments, 2x Phosphors, 1.35 Gy Radiation, Expansion Cohort - 14 Treatments, 1x Phosphors, 2 Gy Radiation, Expansion Cohort - 14 Treatments, 2x Phosphors, 1.35 Gy Radiation, Solid Tumor Cohort |
Primary outcome
Dose-Limiting Toxicity (DLT)
Time frame: 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.
7 secondary outcomes
Evaluate Local Response Rate (LRR)
Time frame: After first 6 weeks of treatment
Evaluate Durability of Response
Time frame: Post first 6 treatments to 2 years post last treatment
Evaluate Objective Response Rate (ORR)
Time frame: After first 6 weeks of treatment
Evaluate Progression Free Survival
Time frame: Post first 6 treatments to 2 years post last treatment
Evaluate Overall Survival
Time frame: Post first 6 treatments to 2 years post last treatment
PK Profile (C max) of Methoxsalen
Time frame: First 6 weeks of study
PK Profile (AUC) of Methoxsalen
Time frame: First 6 weeks of study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported after deidentification for researchers who provide a methodologically sound proposal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lauren Wood, MD contact
William Eward, MD principal investigator
Duke University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing X-PACT in people with Advanced Solid Tumor Cancer, run by Immunolight, LLC at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 46 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan N McLaughlin, BSN (7048776363, smclaughlin@immunolight.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicity (DLT) (time frame: First 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.