RecruitingPhase 1NCT04389281

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

Phase 1 Study of X-PACT (X-ray Psoralen Activated Cancer Therapy) for Intra-tumoral Injection of Superficial Tumors in Patients With Advanced Head and Neck Cancer, Breast Cancer, Soft Tissue Sarcoma or Melanoma

Sponsor

Immunolight, LLC

Enrollment

52 participants

Start Date

Dec 8, 2021

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests X-PACT, a treatment that uses X-rays to activate a drug (psoralen) injected directly into a tumor, causing it to be destroyed from within. It is being tested in people with advanced cancers including head and neck cancer, breast cancer (triple-negative), sarcoma, and melanoma that have not responded to standard therapies. **You may be eligible if...** - You are 18 or older - You have advanced solid cancer that has progressed on standard treatment - You have at least one tumor that can be accessed for injection (not inside an organ) and is less than 5 cm deep - Your overall health is good (ECOG 0-1) and you have a life expectancy of at least 4 months - Your blood counts and organ function meet the required levels **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have a history of sensitivity to light (photosensitivity disorders such as lupus, porphyria, albinism, or xeroderma pigmentosum) - You have previously been exposed to methoxsalen (a psoralen compound) - You have HIV, hepatitis B or C - You have active autoimmune disease requiring significant treatment - You have significant heart disease or uncontrolled high blood pressure - You are on corticosteroids (steroids) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTX-PACT

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.