Holy Stone Announces the Phase 1 Clinical Study Results for CA102N, A New Anti-Cancer Drug

08, Feb 2022
This Phase 1 study was designed as a multicenter, non randomized, open-label, multiple dose, and first in human study of CA102N monotherapy and CA102N combined with trifluridine/tipiracil (LONSURF) in subjects with advanced solid tumors. Three medical centers including MD Anderson, Banner MD Anderson and University Colorado in the US were joined the study. The study consisted of two parts: dose escalation part and dose expansion part, which were performed subsequently to investigate the safety and tolerability of CA102N, pharmacokinetics (PK) properties of CA102N, and preliminary efficacy of CA102N monotherapy and CA102N in combination with LONSURF in subjects.

A total of 37 subjects were enrolled in the study, including 25 in the dose escalation part and 12 in the dose expansion part. The study results showed that CA102N, dose at 0.72 mg/kg (Nimesulide equivalents) as monotherapy or in combination with LONSURF, was safe and well-tolerated in subjects with locally advanced or metastatic solid tumors and/or colorectal cancer. Regarding the PK properties of CA102N, no obvious drug accumulation was observed on Day 15 after the first infusion on Day1 of the 28-day treatment cycle, and the mean T1/2 was from 8 to 15 hours.

Meanwhile, the efficacy of CA102N monotherapy and CA102N in combination with LONSURF in subjects was also evaluated in this study. The preliminary efficacy results showed that CA102N in combination with LONSURF had a better disease control rate (DCR) compared to the CA102N monotherapy in the subject with locally advanced or metastatic solid tumors and/or colorectal cancer. In a retrospective study of LONSURF in patients with chemotherapy refractory metastatic colorectal cancer, the DCR was 24%. The DCR of the dose at 0.72 mg/kg of CA102N (Nimesulide equivalents) and LONSURF combination therapy in this study (dose expansion group) was 54.5%, which is obviously higher than that of LONSURF monotherapy.

CA102N is a hyaluronic acid conjugated drug developed with the company’s Hyaluronan Drug Delivery (HDD) platform. CA102N is a targeted anti-cancer drug for the treatment of colorectal cancer with multiple MOAs in inhibiting tumor growth, therefore, less resistance of CA102N comparing to traditional chemotherapy is expected. CA102N, either administered alone or as a combination therapy with a current drug, has the potential to become the first-line treatment of colorectal cancer.
Colorectal cancer is one of the most common types of cancer in the world. According to “Colorectal Cancer Drugs Global Market Report 2021: Covid 19 Impact And Recovery To 2030”, issued by The Business Research Company in June 2021 indicated that due to the COVID-19 pandemic, the global market of (colorectal cancer CRC) treatments in 2020 and 2021 dropped to USD 6.23 billion and USD 6.09 billion, respectively. However, following the ease of the pandemic, the market is expected to grow gradually and reach USD 6.85 billion in 2025.

Based on the positive trial results reported in the CA102N phase 1 clinical study report, Holy Stone will submit a phase 2 clinical study to US FDA in 2022.
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