X-ray Psoralen Activated Cancer Therapy in Head and Neck, Breast, Sarcoma and Melanoma
ConditionAdvanced Solid Tumor Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorImmunolight, LLC
About 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.
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 criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Age ≥ 18 years at the time of consent
ECOG Performance Status of ≤ 1
A non-visceral tumor, a metastatic lymph node, a metastasis from a visceral solid tumor provided the lesion is extravisceral, or a cutaneous tumor. Visceral tumors will not be treated.
Disqualifiers
Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study.)
Prior exposure to methoxsalen
History of idiosyncratic or hypersensitivity reactions to any of the phosphor device components
Known diagnosis of human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection (NOTE: testing not required)
Trial design
Design model
Parallel
Treatments tested in this trial
X-PACT
Combination productX-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.
Treatment groups
52 Participants
are divided into 5 treatment groupsGroup A: Solid Tumor CohortExperimental treatment 1 intervention
Group B: Expansion Cohort - 10 Treatments, 1x Phosphors, 2 Gy RadiationActive comparator 1 intervention
Group C: Expansion Cohort - 14 Treatments, 1x Phosphors, 2 Gy RadiationActive comparator 1 intervention
Group D: Expansion Cohort - 10 Treatments, 2x Phosphors, 1.35 Gy RadiationActive comparator 1 intervention
Group E: Expansion Cohort - 14 Treatments, 2x Phosphors, 1.35 Gy RadiationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Dose-Limiting Toxicity (DLT)
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.
Time frame
First 6 weeksSecondary outcomes
1
Evaluate Local Response Rate (LRR)
Evaluate local response rate by assessing treated tumor volume pre and post treatment
Time frame
After first 6 weeks of treatment2
Evaluate Durability of Response
Evaluate duration of local control
Time frame
Post first 6 treatments to 2 years post last treatment3
Evaluate Objective Response Rate (ORR)
Evaluate the proportion of patients who have a partial or complete response to therapy.
Time frame
After first 6 weeks of treatment4
Evaluate Progression Free Survival
Evaluate the length of time during and after the treatment that the subject lives with the disease but it does not get worse.
Time frame
Post first 6 treatments to 2 years post last treatmentSponsors and contacts
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Source ClinicalTrials.gov