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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- |
A long term follow up study, to evaluate the long term safety and efficacy, of single agent ATX-101 given by intravenous infusion once every week in patients with advanced solid tumours
A phase 1 dose escalating study to determine incidence of dose limiting toxicities of single agent ATX-101 given by intravenous infusion every week in patients with advanced solid tumours
Phase 1b/2a Study Investigating ATX-101 in Combination With Platinum-based Chemotherapy in Platinum-sensitive, Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancer
This is a Phase 1b/2a multicenter study, which consists of two parts:
Part 1: the Phase 1b part of the study will investigate the safety of the combination of ATX-101 with carboplatin/pegylated liposomal doxorubicin (ACD). ATX-101 will be administered intravenously in three escalation cohorts: 20, 30, and 45 mg/m² according to a 3+3 design. In the case where 20 mg/m² is not tolerated, the dose can be de-escalated to 15 mg/m².
Part 2: the Phase 2a part of the study will investigate the efficacy and safety of ACD.
ATX-101 will be administered at the dose defined in Part 1 of the study.
Treatment will continue up to six cycles or until disease progression or unacceptable toxicity, participant withdrawal of consent, non-compliance, lost to follow-up, or withdrawal at the Investigators discretion, whichever occurs first.
100 项与 Therapim Pty Ltd 相关的临床结果
0 项与 Therapim Pty Ltd 相关的专利(医药)
100 项与 Therapim Pty Ltd 相关的药物交易
100 项与 Therapim Pty Ltd 相关的转化医学