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最高研发阶段临床2期 |
首次获批国家/地区- |
首次获批日期- |
AN OPEN LABEL, RANDOMISED, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF MTL-CEBPA ADMINISTERED IN COMBINATION WITH SORAFENIB OR SORAFENIB ALONE, IN TKI NAÏVE PARTICIPANTS WITH PREVIOUSLY TREATED ADVANCED HEPATOCELLULAR CARCINOMA (HCC) AND HEPATITIS B OR HEPATITIS C VIRUS (OUTREACH2) - Safety, tolerability, and efficacy of MTL-CEBPA plus sorafenib in HCC
AN OPEN LABEL, RANDOMISED, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF MTL-CEBPA ADMINISTERED IN COMBINATION WITH SORAFENIB OR SORAFENIB ALONE, IN TKI NAÏVE PARTICIPANTS WITH PREVIOUSLY TREATED ADVANCED HEPATOCELLULAR CARCINOMA (HCC) AND HEPATITIS B OR HEPATITIS C VIRUS (OUTREACH2) - Safety, tolerability, and efficacy of MTL-CEBPA plus sorafenib in HCC
An Open Label, Randomised Phase 2 Study to Evaluate the Safety and Efficacy of MTL-CEBPA Administered in Combination With Sorafenib or Sorafenib Alone in TKI naïve Participants With Previously Treated Advanced Hepatocellular Carcinoma (HCC) and Hepatitis B or Hepatitis C Virus (OUTREACH2)
This is a Phase II study in patients with advanced liver cancer (hepatocellular carcinoma) as a result of hepatitis B and/or C infection. Participants will be dosed with either MTL-CEBPA (an experimental treatment) and sorafenib or sorafenib alone. The MTL-CEBPA is administered once every 3 weeks via intravenous infusion. Sorafenib is taken orally from Day 8 for the combination group or Day 1 for the sorafenib alone group at a dose of 400 mg twice a day. Participants will receive 3 week cycles of treatment until disease progression, unacceptable toxicity, withdrawal of consent or death occurs. The combination of MTL-CEBA and sorafenib combination of treatment was tested in a previous Phase I study (OUTREACH) which showed anti-tumour activity along with a good safety and toxicity profile.
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100 项与 Mina Alpha Limited 相关的药物交易
100 项与 Mina Alpha Limited 相关的转化医学