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. Intra-tumoral injections will be given on 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.

Advanced Cancer

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.

X-PACT

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 in Patients With Advanced Head and Neck Cancer, Breast Cancer, Soft Tissue Sarcoma or Melanoma

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.

Evaluate local response rate by assessing treated tumor volume pre and post treatment

Evaluate the proportion of patients who have a partial or complete response to therapy.

Evaluate the length of time during and after the treatment that the subject lives with the disease but it does not get worse.

Evaluate the length of time subjects stay alive from the date of first treatment.

Establish C max of methoxsalen when given as an intra-tumoral injection

Establish AUC of methoxsalen when given as an intra-tumoral injection

Individual participant data that underlie the results reported after deidentification for researchers who provide a methodologically sound proposal.

Immunolight, LLC

Combination metyrosine-derivative, low-dose methoxsalen, phenytoin and sirolimus

Combination metyrosine-derivative, low-dose methoxasalen, phenytoin and sirolimus

Sarcoma, Ewing

Sarcoma

Daily oral combination therapy for cancer

Combination metyrosine-derivative, low-dose methoxsalen, phenytoin and sirolimus (MPS)

Sarcoma Oncology Research Center

SM-88 as Maintenance Therapy for Advanced Ewing's Sarcoma Patients and as Salvage Therapy for Sarcoma Patients

A Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of SM-88 Used With Methoxsalen, Phenytoin, and Sirolimus (MPS) as Response Maintenance Therapy Following Standard Treatments for Patients With Ewing's Sarcoma or as Salvage Therapy for Patients With Clinically Advanced Sarcomas

Complete response (CR) + partial response (PR) as evaluated using RECIST 1.1

Stable disease (SD) as evaluated using RECIST 1.1

From date of enrollment until the date of first documented progression, as evaluated using RECIST 1.1, or date of death, whichever occurs first

From date of CR or PR until the date of first documented progression, as evaluated using RECIST 1.1

From date enrollment until the date of death

Adverse events will be assessed at each visit and at unscheduled visits as clinically indicated

methoxsalen/sarcoma

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

SM-88 as Maintenance Therapy for Advanced Ewing's Sarcoma Patients and as Salvage Therapy for Sarcoma Patients

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