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NCT05188729 (LTX-315 Part 1 VP-315… in Basal Cell Carcinoma): BVCT ex-ante prediction vs. reported outcome

On 9 Apr 2024, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 14 Aug 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient (inferior to imiquimod).

Clinical Trial

NCTID
NCT05188729
Drug Name
LTX-315 Part 1 VP-315 Part 2
Drug MoA
oncolytic peptide immunotherapy derived from bovine lactoferrin
Drug Modality
oncolytic peptide therapy
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Basal Cell Carcinoma
Human Patients
80
Sponsor
Verrica Pharmaceuticals
Phase
Phase 2

Prediction of , index 1535

Prospective Prediction
Prediction Index
1535
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit inferior to imiquimod)
Technical Prediction
SUCCESS (statistically significant clinical benefit in clinical clearance)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
127 days in advance
Readout Data Interpretation
51% CR lower than 80% CR achieved by imiquimod (DOI- 10.1016/j.jaad.2003.11.066).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient (inferior to imiquimod)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 2, Multicenter, Open-label, Proof-of-concept Study With Safety Run-in to Evaluate the Safety, Pharmacokinetics, and Efficacy of VP-315 in Adult Subjects With Basal Cell Carcinoma
Phase
Phase 2
Status
Completed
Enrollment
92
Lead sponsor
Verrica Pharmaceuticals Inc.
Conditions
Basal Cell Carcinoma; Skin Cancer; Cancer of the Skin, Basal Cell; Cancer of the Skin; Carcinoma
Interventions
DRUG: Part 1: VP-315 3 Day Dosing/Week; DRUG: Part 2: VP-315 3 Day Dosing/Week - Loading Dose; DRUG: Part 2: VP-315 3 Day Dosing/Week - No Loading Dose; DRUG: Part 2: VP-315 2 Day Dosing/Week - Split Dose; DRUG: Part 2: VP-315 3 Day Dosing/Week - Split Dose
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2022-02-01
Primary completion
2024-04-15
Completion
2024-04-15
Results first posted
2025-06-18
Primary outcomes
  • Part 1: Percentage of Subjects With Discontinuations Due to Adverse Events (Up to 9 weeks)
  • Part 1: Percentage of Subjects With Dose-limiting Toxicities (DLTs) (Day 4 (Safety Assessment))
  • Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity (Up to 9 weeks)
  • Part 2: Percent of Subjects With Adverse Events (Up to 15 weeks)
  • Part 2: Percentage of Subjects With Study Discontinuations Due to Adverse Events (Up to 15 weeks)

NCT05188729 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials