AsiDNA (a DNA Repair Inhibitor) Administered IntraVenously in Advanced Solid Tumors

Phase 1 Completed 33 enrolled Valerio Therapeutics

NaSingle-groupOpen-labelTreatment

Summary

The aim of the study is to assess: * Part A: the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of AsiDNA in patients with advanced solid tumors. * Part B: the safety and preliminary efficacy of AsiDNA in combination with Carboplatin with or without Paclitaxel in patients with Advanced solid tumors.

Timeline

Start: 2018-04-05
Primary completion: 2021-02-24
Completion: 2022-02-20

Publications

Le Tourneau C, Delord JP, Kotecki N, Borcoman E, Gomez-Roca C, Hescot S, Jungels C, Vincent-Salomon A, Cockenpot V, Eberst L, Mole A, Jdey W, Bono F, Trochon-Joseph V, Toussaint H, Zandanel C, Adamiec O, de Beaumont O, Cassier PA. A Phase 1 dose-escalation study to evaluate safety, pharmacokinetics and pharmacodynamics of AsiDNA, a first-in-class DNA repair inhibitor, administered intravenously in patients with advanced solid tumours. Br J Cancer. 2020 Nov;123(10):1481-1489. doi: 10.1038/s41416-020-01028-8. Epub 2020 Aug 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AsiDNA	Oligonucleotide (other)	200 mg	Intravenous
Subject	AsiDNA	Oligonucleotide (other)	400 mg	Intravenous
Subject	AsiDNA	Oligonucleotide (other)	600 mg	Intravenous
Subject	AsiDNA	Oligonucleotide (other)	900 mg	Intravenous
Subject	AsiDNA	Oligonucleotide (other)	1300 mg	Intravenous

Indications

No indication recorded.