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NCT04389281 · ClinicalTrials.gov registry record · Phase 1
X-ray Psoralen Activated Cancer Therapy in Head and Neck, Breast, Sarcoma and Melanoma
A Phase 1 study of Advanced Solid Tumor Cancer, sponsored by Immunolight.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 4
- Study locations
NCT04389281: Recruiting Phase 1 study of Advanced Solid Tumor Cancer, sponsored by Immunolight.
NCT04389281 is a Phase 1 study of Advanced Solid Tumor Cancer that is actively recruiting participants, run by Immunolight. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04389281, a Phase 1 study of Advanced Solid Tumor Cancer, is actively recruiting participants, sponsored by Immunolight.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- COMBINATION_PRODUCT X-PACT
Study Locations (4)
North Carolina
- Levine Cancer Institute - Charlotte
- Duke University - Durham
District of Columbia
- Sibley Hospital - Johns Hopkins University - Washington D.C.
South Carolina
- Prisma Health - Greenville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2021-12-08 |
| Est. Completion | 2029-03 |
| Phase | Phase 1 |
What NCT04389281 shows while recruiting
NCT04389281 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 1 condition, with Advanced Solid Tumor Cancer appearing as the primary indexed condition, and to 1 intervention - of which X-PACT is the first listed.
NCT04389281 reports a single indexed study location in North Carolina, District of Columbia, South Carolina.
Frequently Asked Questions
What is clinical trial NCT04389281 about?
NCT04389281 is a clinical study titled "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 inj...
What is the current status of trial NCT04389281?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2021-12-08. Estimated completion is 2029-03.
What conditions does trial NCT04389281 study?
This clinical trial studies the following conditions: Advanced Solid Tumor Cancer.
What interventions are being tested in trial NCT04389281?
The interventions under investigation include: X-PACT (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04389281?
This trial is sponsored by Immunolight, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04389281 being conducted?
This trial has 4 study locations across District of Columbia, North Carolina, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04389281's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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