What question did this study set out to answer?

This trial aimed to assess the safety and efficacy of VT-1953 topical gel in managing symptoms of malignant fungating wounds.

April 19, 2026

Abstract CT208: Final results from a phase 2 trial testing safety and efficacy of VT-1953 topical gel in patients with malodorous malignant fungating wound

Key Points

This trial aimed to assess the safety and efficacy of VT-1953 topical gel in managing symptoms of malignant fungating wounds.
Conducted an open-label phase 2 clinical trial
Included patients aged ≥9 years with malignant fungating wounds
Applied VT-1953 gel twice daily for 14 days; compared to a vehicle arm
Primary endpoint was change in malodor score using the TELER scale
Secondary endpoints included pain and quality of life assessments via VAS.
15 patients evaluated, with 10 in the VT-1953 arm and 5 in the vehicle arm
No treatment-emergent side effects reported
Significant decrease in malodor and pain levels observed
Improvement in quality of life metrics reported

Abstract

Abstract Background: Malignant fungating wound (MFW) is a chronic inflammatory condition that afflicts 5-14% of patients with advanced cancers. MFWs are extremely distressing to patients (pts) given their high burden of symptoms, including extreme malodor and pain. The malodor associated with MFWs has a significant negative effect on quality of life (QOL). Currently, there are no approved treatments for the symptoms of malodorous MFW. There is a need for an effective treatment of symptoms of MFW. Methods: VT-1953 is a dual DNA gyrase and MD2-TLR inhibitor. We tested the safety and efficacy of VT-1953 2% topical gel in an open-label, investigator-initiated phase 2 clinical trial (CTRI/2024/05/066875). Male or female pts aged ≥9 years with a diagnosis of malodorous MFW corresponding to 0, 1 or 2 on the 6-point TELER odor scale, ECOG performance status ≤3, and anticipated survival ≥3 months were eligible. VT-1953 (7. 5 g) was applied twice daily to wounds for 14 days; a vehicle arm was included for comparison. The primary endpoint was the change in malodor score associated with MFW from baseline (BL) to Day 14, rated by investigators using the TELER scale. Secondary endpoints were the change in investigator-rated malodor (TELER) at Day 7 from BL. Exploratory endpoints included change in pt-rated malodor (10-point VAS) at Days 7 and 14, change in pain associated with MFW (by pts) using a 10-point VAS and the change in QOL (by pts) using a 10-point VAS on Days 7 and 14 compared to BL. Results: At the time of the final analysis, 15 pts were eligible and included; 10 pts were in the VT-1953 arm and 5 in the vehicle arm. The results are summarized in the Table. There were no treatment-emergent side effects and no severe local skin reactions. Conclusions: Our data indicate that VT-1953 has a favorable safety profile, significantly decreased malodor and pain, and improved the QOL of pts with MFW. These results support VT-1953 as a promising option for the symptomatic management of MFW. Citation Format: Arshit Narang, Prashant Prakash Lad, Shiladitya Sengupta. Final results from a phase 2 trial testing safety and efficacy of VT-1953 topical gel in patients with malodorous malignant fungating wound abstract. In: Proceedings of the American Association for Cancer Research Annual Meeting 2026; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts) ; 2026 Apr 17-22; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2026;86 (8Suppl): Abstract nr CT208.

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