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

NCT04389281 | Recruiting Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: X-PACT 101
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 4

Brief 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. 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

Advanced Solid Tumor Cancer

Keywords

Advanced Head & Neck Cancer; Advanced Breast Cancer; Advanced Melanoma; Advanced Soft Tissue Sarcoma; Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• 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.

  First 6 weeks

Secondary Outcomes (7)

• Evaluate Local Response Rate (LRR)

  After first 6 weeks of treatment

• Evaluate Durability of Response

  Post first 6 treatments to 2 years post last treatment

• Evaluate Objective Response Rate (ORR)

  After first 6 weeks of treatment

• Evaluate Progression Free Survival

  Post first 6 treatments to 2 years post last treatment

• Evaluate Overall Survival

  Post first 6 treatments to 2 years post last treatment

Study Arms (5)

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

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

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

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

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

Combination Product: X-PACT

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• % 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.
• Demonstrate adequate organ function as defined in the table below:
• Hematological:

You may not qualify if:

• 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:
• a. Idiosyncratic or hypersensitivity reactions to any psoralen compounds or any of their excipients
• b. Light sensitive disease state
• c. Disease associated with photosensitivity including lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum and albinism
• d. 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:
• a. Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded)

Sponsors & Collaborators

• Immunolight, LLC: lead

Study Sites (4)

Sibley Hospital - Johns Hopkins University

Washington D.C., District of Columbia, 20016, United States

RECRUITING

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

Prisma Health

Greenville, South Carolina, 29605, United States

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• William Eward, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan N McLaughlin, BSN

CONTACT

7048776363; smclaughlin@immunolight.com

Lauren Wood, MD

CONTACT

6788995225

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 15, 2020
• Study Start: December 8, 2021
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 6 months after the article publication to 36 months following article publication
• Access Criteria: Proposals should be directed to smclaughlin@immunolight.com or lwood@immunolight.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 36 months on a third party website.

Locations

US (4)