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

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Valerio Therapeutics
Study ID
NCT05700669
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AsiDNA — DRUG
    All patients will receive a loading dose of AsiDNA intravenously (D1, D2, D3) followed by weekly intravenous administrations in combination with Olaparib.
  • Olaparib — DRUG
    Olaparib is given orally in combination with AsiDNA

Study Details

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.

Key Dates

Start date
Feb 20, 2023
Status verified
Sep 2024
Primary completion
Oct 31, 2023
Completion
Oct 31, 2023

Study Design

Enrollment
3 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    Three dose levels of AsiDNA delivered intravenously weekly in combination with Olaparib
  • Experimental: Dose Expansion: Recurrent Epithelial Ovarian Cancer Cohort
    Recommended Phase 2 dose of AsiDNA delivered intravenously weekly in combination with Olaparib
  • Experimental: Dose Expansion: Metastatic Castration-resistant Prostate Cancer Cohort
    Recommended Phase 2 dose of AsiDNA delivered intravenously weekly in combination with Olaparib
  • Experimental: Dose Expansion: Recurrent Breast Cancer Cohort
    Recommended Phase 2 dose of AsiDNA delivered intravenously weekly in combination with Olaparib

Primary Outcome Measure

Phase 1b: Evaluate the safety and tolerability and determine the recommended Phase 2 dose (RP2D) of AsiDNA administered in combination with olaparib in participants with advanced and/or metastatic ovarian, breast, or prostate cancer. [ Time Frame: Baseline to Week 26 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Next OncologySan AntonioTexas78229-

Find similar trials in San Antonio, TX

By condition
Breast cancerProstate cancer
By specialty
OncologyBreast oncologyWomen's healthProstate oncologyMen's healthUrology
By research site
Next Oncology· San Antonio, TX

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