Astrazeneca PLC Sponsored ADR(AZN.US) launches first phase III clinical trial for its self-developed ADC drug in China.
AstraZeneca (AZN.US) has initiated the first Phase III clinical trial of its self-developed ADC drug in China.
On April 3, the official website of the Drug Clinical Trial Registration and Information Disclosure Platform showed that Astrazeneca PLC Sponsored ADR (AZN.US) registered a clinical trial of AZD5335 for the treatment of platinum-resistant advanced ovarian epithelial cancer patients with folate receptor (FR) positivity (high and low expression) after 1-3 lines of treatment (registration number: CTR20261196).
Source: Drug Clinical Trial Registration and Information Disclosure Platform official website
This is the initiation of the domestic clinical part of the TREVI-OC-01 study. TREVI-OC-01 is a randomized, open-label, Phase III study aimed at evaluating the efficacy and safety of AZD5335 compared to standard treatment (SoC) in platinum-resistant recurrent ovarian cancer subjects with high or low FR expression who have previously received 1-3 lines of systemic therapy. In the high FR expression group, the comparator for AZD5335 is bevacizumab, and in the low FR expression group, it is compared to the chemotherapy regimen chosen by the investigator.
According to Insight database, there is currently only one FR ADC approved for marketing globally, which is bevacizumab's farletuzumab, but it is only used in adult patients with platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with FR positivity. In addition, there are four other FR ADCs advancing to Phase III clinical trials, from Roche, Astrazeneca PLC Sponsored ADR, Bio-Thera Solutions, and Genmab.
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