OncoMatch/Clinical Trials/NCT04389281
X-ray Psoralen Activated Cancer Therapy in Head and Neck, Breast, Sarcoma and Melanoma
Is NCT04389281 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies X-PACT for advanced solid tumor cancer.
Treatment: X-PACT — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Excluded: HER2 (ERBB2) ultra-low
For the TNBC Cohort, patients determined to be HER2 ultra-low will not be enrolled.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: best medical treatment — locally advanced, relapsed, refractory or metastatic disease
Subjects with histologically or cytologically confirmed advanced solid tumors which have progressed after standard therapy(ies), intolerant to standard therapy, refused standard therapy or for which no standard therapy(ies) exist.
Must have received: best medical treatment — TNBC Cohort: unresectable, locally advanced, relapsed, refractory or metastatic disease
For the TNBC Cohort, participants must have either unresectable, locally advanced, relapsed, refractory or metastatic disease with HER2 negative/low ER/PR status (<10%) or HER2 negative/ER/PR negative. Patients determined to be HER2 ultra-low will not be enrolled. Furthermore, participants must have received at least one prior treatment (best medical treatment for cancer stage, PDL-1 status, BRCA 1 or 2 status and general health status)... Participants who are intolerant or refuse best medical care would also be eligible.
Must have received: best medical treatment (surgery, radiation, chemotherapy (including doxorubicin, Trabectedin), gene therapy, targeted therapy (pazopanib), antibody-drug conjugates) — STS Cohort: unresectable, locally advanced, relapsed, refractory or metastatic disease
For the STS Cohort, participants must have received at least one prior treatment (best medical treatment recommended for the participants sub-type) for unresectable, locally advanced, relapsed, refractory or metastatic disease. Participants who are intolerant to or have refused best medical treatment for their subtype will also be eligible. Best medical treatment includes: surgery, radiation, chemotherapy (including doxorubicin, Trabectedin), gene therapy, targeted therapy (pazopanib) or antibody-drug conjugates.
Cannot have received: methoxsalen (methoxsalen)
Prior exposure to methoxsalen
Cannot have received: systemic anti-cancer treatment
Systemic anti-cancer treatment within 28 days (or 5 half-lives, whichever is shorter) prior to day 1 of treatment
Cannot have received: investigational drug
Treatment with any investigational drug within 5 half-lives or 28 days, whichever is shorter (or if half-life is unknown, within 28 days) prior to day 1 of treatment
Cannot have received: corticosteroids
Exception: inhaled or topical steroids are permitted
Receiving or planned use of corticosteroids. Subjects will require a one-week washout period from prior corticosteroid use. Inhaled or topical steroids are permitted.
Lab requirements
Blood counts
WBC ≥ 3 x 10^9/L; ANC ≥ 1.5 x 10^9/L; Platelet Count ≥ 100 x 10^9/L; Hemoglobin (Hgb) ≥ 8 g/dL
Kidney function
Serum creatinine OR Creatinine clearance ≤ 1.5 x ULN OR, in patients with a serum creatinine 1.5 x ULN, ≥ 60 mL/min as measured by a 24-hour urine collection or estimated by the Cockcroft and Gault formula
Liver function
Total bilirubin ≤ 1.5 × ULN (in patients with known Gilbert Syndrome a total bilirubin ≤3.0× ULN with direct bilirubin ≤1.5 X ULN); AST ≤ 2.5 × ULN (or ≤ 5 if liver metastases are present); ALT ≤ 2.5 × ULN (or ≤ 5 if liver metastases are present)
Demonstrate adequate organ function as defined in the table below
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Sibley Hospital - Johns Hopkins University · Washington D.C., District of Columbia
- Levine Cancer Institute · Charlotte, North Carolina
- Duke University · Durham, North Carolina
- Prisma Health · Greenville, South Carolina
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