Abstract CT169: Bioplatin (NTPX-07) as an oral nano platinum in patients of advanced stage malignancy: Outcomes of a phase I clinical trial

Abstract

Abstract Purpose: Platinum derivatives are widely used for treating a variety of solid tumours. Besides its direct cytotoxic action, Platinum derivatives play an important role in antitumor immune response, mainly by its inherent capacity to induce immunogenic cell death. Induction of apoptosis using novel therapeutics can be considered a key therapeutic strategy for preventing recurrence and metastasis in cancer patients. Bioplatin is an oral, nano platinum-based compound manufactured using patented innovative processing, based on green technology with an aim of retaining its anti-cancer properties while at the same time reducing its dose limiting toxicities. This compound has demonstrated the property of inducing apoptosis in cancer cells by preventing DNA replication. Since Bioplatin is developed with an aim of arresting disease progression and improving progression-free survival/disease-free survival its administration is expected to be for a longer duration hence its oral dosing and good tolerability are of utmost importance. Methods: The present study, Phase-I multicentric clinical trial (CTRI/2017/06/008778) was conducted. with an aim of determining the maximum tolerated dose, safety, tolerability and effect on Quality-of-life (QoL) Bioplatin was administered orally for 21 consecutive days to advanced-stage cancer patients of solid tumours who were not responding to any conventional anticancer therapy. Dose escalation was carried out to determine the Maximum Tolerated Dose (MTD). Results: A total of 14 patients received Bioplatin at 4 dose levels, 10 mg, 20 mg, 40 mg, and 60 mg Cohort. The mean progression-free survival (PFS) was 40.25 ± 13.47 days. The highest mean PFS of 50.67 ± 6.66 days was observed in the 40 mg Cohort. The mean PFS was 37.67 ± 16.74 days in 60 mg cohort. Analysis of QoLusing FACT-G showed improvement in QoL (FACT-G) in the 60 mg cohort as compared to Day 1 (p<0.05). No dose-limiting toxicity was reported. Conclusion: Considering that Bioplatin can be administered orally, its tolerability, and its property to delay tumor growth, we propose that it can be used for the treatment of patients with platinum-sensitive tumours. Bioplatin has the potential as an orally consumable immunotherapy agent for longer duration. It is expected to increase disease-free survival (DFS) post-surgery/chemotherapy or as maintenance therapy with other agents in advanced stages patients of platinum-sensitive tumours for improving Quality of life and increasing survival. The findings of the study warrant further clinical evaluation. Citation Format: Yogesh Bendale, Vikram Gota, Rajnish Nagarkar, Eeshani Bendale, Nandinee Khot, Surendra Nagre, Avinash Kadam. Bioplatin (NTPX-07) as an oral nano platinum in patients of advanced stage malignancy: Outcomes of a phase I clinical trial [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 2 (Clinical Trials and Late-Breaking Research); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(8_Suppl):Abstract nr CT169.