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

Trial Details

NCT ID
NCT04389281
Phase
PHASE1
Sponsor
Immunolight, LLC
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • X-PACT
Locations (sample)
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637
  • Charlotte, North Carolina, United States|35.22709,-80.84313
  • Durham, North Carolina, United States|35.99403,-78.89862
  • Greenville, South Carolina, United States|34.85262,-82.39401

Key Eligibility Criteria

  • Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the infor…
  • 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 stan…

For full eligibility, visit ClinicalTrials.gov.

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