Abstract CT091: Interim results from a phase 2 trial testing the safety and efficacy of VT-1953 topical gel in patients with malodorous malignant fungating wound

Abstract Background: Malignant fungating wound (MFW) is a chronic inflammatory condition that afflicts 5-14% of patients with advanced cancers. MFW is 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: VT1953 is a dual DNA gyrase and MD2-TLR inhibitor. We tested the safety and efficacy of VT-1953 2% topical gel in an ongoing open-label, investigator-initiated phase 2 clinical trial (CTRI/2024/05/066875). Male or female pts aged ≥9 with a diagnosis of malodorous MFW corresponding to 0,1 and 2 on the 6-point TELER odor scale, ECOG performance status of ≤3 and anticipated survival of ≥3 months were eligible. VT-1953 (7.5g) was applied twice daily to wounds for 14 days. The primary endpoint was the difference in the mean score of malodor associated with MFW (by investigators) using the TELER Scale on Day 14 compared to baseline (BL). Exploratory endpoints included the differences in the mean score of pain associated with MFW (by pts) using a 10-point Visual Analog Scale (VAS) on days 7 and 14 compared to BL and the mean score of QOL associated with MFW (by pts) using 5-point VAS on days 7 and 14 compared to BL. Results: At the time of this interim analysis, 8 patients were eligible and included. The results are summarized in the Table. There were no treatment-emergent side effects and no severe local skin reactions. Conclusions: Our data indicates 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. Interim results from a phase 2 trial testing the 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 2025; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_2):Abstract nr CT091.