Does LTX-315 work?
Not properly: one early safety trial of 39 patients, with no comparison group.
The only published human data in the citations are a phase 1 dose-escalation study of intratumoral injection in 39 patients with accessible solid tumors, uncontrolled and designed for safety. Earlier animal work established the mechanism. No randomized trial exists, so the grade is C despite the drug reaching phase 2. 1
The phase 1 study treated 39 patients with advanced solid tumors (melanoma, breast cancer, sarcoma, and others). Doctors injected accessible lesions again and again. The drug was tolerable. The most common treatment-related effects were brief low blood pressure (46% of patients), injection-site reactions (38%) and flushing (28%). Biopsies of injected tumors showed necrosis. In 12 of 14 sampled tumors, more CD8 T cells had moved in after treatment. Injected tumors shrank by at least 30% in volume in 29% of patients. But no patient met the criteria for a partial response. Shrinkage of lesions that were not injected would show an immune effect across the body. The study reported that only as isolated evidence. 1
No one has published a controlled trial. The basal cell carcinoma phase 2 posted results on ClinicalTrials.gov in June 2025, but they have not been reported in a peer-reviewed form. 23
Evidence checklist
- Randomised controlled trial Phase 1 only, no control group
- Human study over 100 people 39 patients in the phase 1
- More than one research group Developed by one company
- Clinical outcomes, not surrogate markers Tumor changes, not survival
- Human safety data beyond case reports Phase 1 safety in 39 patients
More on LTX-315
Citations
- Spicer 2021, Clin Cancer Res: Phase 1 study of intratumoral LTX-315 in advanced solid tumors pubmed.ncbi.nlm.nih.gov
- Verrica Pharmaceuticals 2021: FDA acceptance of IND application for LTX-315 in basal cell carcinoma verrica.com
- ClinicalTrials.gov: NCT05188729, VP-315 phase 2 trial in basal cell carcinoma clinicaltrials.gov
Reference information only, not medical advice. Drawn from the LTX-315 article, fact-checked against the cited sources. No dosing anywhere on this site.