Single Patient Compassionate Use of X-PACT in Salvage Treatment of Prostate Cancer

NCT06836648 | Unknown

• 2 other identifiers: SIBCOM2502spIRB00482834
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Due to the subject's lack of conventional treatment options, a treatment plan using X-PACT administered intra-tumorally is proposed. X-PACT (X-ray Psoralen Activated Cancer Therapy) is comprised of a phosphor device (an energy modulation agent), methoxsalen sterile solution (a psoralen), X-ray energy and represents a potential new approach for the treatment of solid tumors. Methoxsalen is a psoralen found in the seeds of the Ammi majus (Umbelliferae) plant. Importantly, methoxsalen (whether formulated as the sterile solution \[Uvadex®\] or as a hard gelatin capsule \[8-MOP®\]) can promote a strong long-term clinical response, as observed in the treatment of cutaneous T cell lymphoma (CTCL) utilizing extracorporeal photopheresis (ECP) and is approved by the United States Food and Drug Administration \[US FDA\] for this indication. In ECP, malignant CTCL cells are irradiated with UVA light in the presence of methoxsalen and then re-administered to the patient. X-PACT may offer the potential for local control of primary or metastatic disease via administration of the combination product of methoxsalen and powerful energy converters (Phosphors) when activated by x-ray beam. In addition, there is numerous data in support of an immunogenic role for activated methoxsalen. The cytotoxic and immunogenic effects of psoralens are often attributed to psoralen mediated photo-adduct DNA damage \[1\]. A principle mechanism underlying the long term immunogenic clinical response likely derives from psoralen induced tumor cell cytotoxicity and uptake of the apoptotic cells by immature dendritic cells, in the presence of inflammatory cytokines \[2, 3 4, 5\]. However, photochemical modification of proteins and other cellular components can also impact the antigenicity and potential immunogenicity of treated cells \[6\]. The diversity and potency of psoralen application is further illustrated by recent success using psoralen in the development of virus vaccines \[7\]. The immunogenic activity of methoxsalen supports a potential abscopal effect for X-PACT particularly as it incorporates both radiation and an immunotherapeutic.

Conditions

Prostate Cancer

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is willing and able to provide informed consent. Only the patient for whom this clinical study/experimental treatment was designed will be given the investigational drug under the treatment of the PI. No other patient is authorized to participate in or to receive treatment under this treatment protocol.

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Immunolight, LLC: collaborator

Study Sites (1)

Kimmel Cancer Center at Johns Hopkins at Sibley Memorial Hospital

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

AVAILABLE

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Panagis Galiatsatos, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Panagis Galiatsatos, MD

CONTACT

4103672014; pgaliat1@jhmi.edu

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 20, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

US (1)