Valerio Therapeutics
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.
Metastatic Castration-resistant Prostate Cancer
Recurrent Epithelial Ovarian Cancer
Breast Cancer
Acidic
Take it
Phase 1
Phase 2
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 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. Once the RP2D has been determined the Phase 2 study will proceed evaluating AsiDNA in combination with olaparib in participants with recurrent ovarian cancer, recurrent breast cancer and recurrent CRPC that failed or progressed on PARP inhibitors (PARPi) therapy. The objective of Phase 2 study is to evaluate the preliminary efficacy as measured by ORR of AsiDNA in combination with olaparib in each of the three cohorts. Eligible participants will be included to receive AsiDNA by IV infusion in addition to olaparib.}}
Study Type : | Interventional |
Estimated Enrollment : | 115 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | A Phase 1b/2 Basket Study To Assess The Safety And Efficacy Of AsiDNA™ In Combination With Olaparib In Participants With Recurrent Solid Tumors |
Actual Study Start Date : | February 20, 2023 |
Estimated Primary Completion Date : | December 2026 |
Estimated Study Completion Date : | April 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: Dose Escalation Three dose levels of AsiDNA delivered intravenously weekly in combination with Olaparib |
Other: Assidna Other: Olaparib |
Experimental: Dose Expansion: Recurrent Epithelial Ovarian Cancer Cohort Recommended Phase 2 dose of AsiDNA delivered intravenously weekly in combination with Olaparib |
Other: Assidna Other: Olaparib |
Experimental: Dose Expansion: Metastatic Castration-resistant Prostate Cancer Cohort Recommended Phase 2 dose of AsiDNA delivered intravenously weekly in combination with Olaparib |
Other: Assidna Other: Olaparib |
Experimental: Dose Expansion: Recurrent Breast Cancer Cohort Recommended Phase 2 dose of AsiDNA delivered intravenously weekly in combination with Olaparib |
Other: Assidna Other: Olaparib |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Next Oncology
Saint Anthony, Texas, United States, 78229