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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Immunolight, LLC
Study ID
NCT04389281
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • X-PACT — COMBINATION_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 Details

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.

Key Dates

Start date
Dec 8, 2021
Status verified
Jan 2026
Primary completion
Sep 30, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Solid Tumor Cohort
    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
  • Active Comparator: Expansion Cohort - 10 Treatments, 1x Phosphors, 2 Gy Radiation
    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
  • Active Comparator: Expansion Cohort - 14 Treatments, 1x Phosphors, 2 Gy Radiation
    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
  • Active Comparator: Expansion Cohort - 10 Treatments, 2x Phosphors, 1.35 Gy Radiation
    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
  • Active Comparator: Expansion Cohort - 14 Treatments, 2x Phosphors, 1.35 Gy Radiation
    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

Primary Outcome Measure

Dose-Limiting Toxicity (DLT) [ Time Frame: First 6 weeks ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Sibley Hospital - Johns Hopkins UniversityWashington D.C.District of Columbia20016
Panagis Galiatsatos, MD
Levine Cancer InstituteCharlotteNorth Carolina28204
Heather Neagle
Shahab Babakoohi, MD
Duke UniversityDurhamNorth Carolina27710
Betsy Sachs
Willam Eward, MD (PRINCIPAL_INVESTIGATOR)
Prisma HealthGreenvilleSouth Carolina29605
William J Edenfield, MD

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Sibley Hospital - Johns Hopkins University· Washington D.C., DCLevine Cancer Institute· Charlotte, NCDuke University· Durham, NCPrisma Health· Greenville, SC

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