drugset / Trial / NCT05700669

Study to Assess Safety and Efficacy of AsiDNA in Combination with Olaparib in Participants with Recurrent Solid Tumors

NCT05700669

Phase 1/2 Completed 3 enrolled Valerio Therapeutics
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a phase 1b/2 open-label, multicenter, basket study to determine the safety, anti-tumor activity, tolerability, and pharmacokinetics /pharmacodynamics of AsiDNA in combination with olaparib in participants with recurrent epithelial ovarian cancer, breast cancer and metastatic castration-resistant prostate cancer who have progressed on previous Poly (ADP-ribose) polymerase (PARP) inhibitor therapy. The study will be conducted in two phases. The Phase 1b dose escalation study designed to establish the safety, tolerability, pharmacologically active doses/ maximum tolerated dose and/or recommended phase 2 dose of AsiDNA in combination with olaparib.

Timeline

Start
2023-02-20
Primary completion
2023-10-31
Completion
2023-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject AsiDNA Oligonucleotide (other) Intravenous
Subject Olaparib Small molecule Oral