A Study to Evaluate the Combination of ATX-101 and Platinum-based Chemotherapy
Summary
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.
Timeline
- Start
- 2021-09-01
- Primary completion
- 2023-11-30
- Completion
- 2023-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ATX-101 | Peptide | 15 mg/m2 | Intravenous |
| Subject | ATX-101 | Peptide | 20 mg/m2 | Intravenous |
| Subject | ATX-101 | Peptide | 30 mg/m2 | Intravenous |
| Subject | ATX-101 | Peptide | 45 mg/m2 | Intravenous |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Doxorubicin | Other / unclassified | 30 mg/m2 | Intravenous |