X-PACT for Advanced Cancers
Trial Summary
What is the purpose of this trial?
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.
Do I have to stop taking my current medications for the trial?
The trial requires a one-week period without corticosteroids before starting, and you must not have had systemic anti-cancer treatment within 28 days before the trial. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
What makes the X-PACT treatment unique for advanced cancers?
X-PACT is unique because it combines X-ray radiation with a drug called psoralen, which is activated by the radiation to target cancer cells specifically. This dual approach aims to enhance the effectiveness of the treatment by directly attacking cancer cells while minimizing damage to surrounding healthy tissue.12345
Research Team
William Eward, DVM, MD
Principal Investigator
Duke University
Eligibility Criteria
Adults over 18 with advanced head & neck cancer, breast cancer, soft tissue sarcoma or melanoma can join this trial if their tumor is superficial (less than 5 cm deep), measurable by RECIST criteria, and accessible for injection. They must have an ECOG Performance Status of ≤1, adequate organ function, no severe allergies to psoralen compounds or the phosphor device components, not be pregnant/breastfeeding and agree to use effective contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive X-PACT treatment as intra-tumoral injections over a period of 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Optional Booster Treatment
Eligible participants receive two additional booster treatments 4-6 weeks apart
Open-label Extension
Participants who respond to treatment may receive an additional 12 treatments over 12 months
Treatment Details
Interventions
- X-PACT
Find a Clinic Near You
Who Is Running the Clinical Trial?
Immunolight, LLC
Lead Sponsor