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.
Condition | Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, High Grade Serious or Endometrioid Carcinoma of the Ovary, Fallopian Tube, or Primary Peritoneal Cancer |
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Treatment | ATX-101 + Carboplatin + Pegylated liposomal doxorubicin (ACD) |
Clinical Study Identifier | NCT04814875 |
Sponsor | THERAPIM PTY LTD |
Last Modified on | 4 October 2022 |
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