Study on the Safety and Effectiveness of AsiDNA and Olaparib for Recurrent Solid Tumors

Sponsor: Valerio Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05700669

Provider View

This clinical trial is testing a new combination of drugs, AsiDNA and Olaparib, to see if they are safe and effective in treating patients with recurrent ovarian, breast, or prostate cancer that has returned after previous treatments.

Patient Parameters

Program Overview

This study is exploring a new treatment using AsiDNA and Olaparib for patients with recurrent ovarian, breast, or prostate cancer that has come back after previous treatments. The study is in two parts: Phase 1b will determine the safest and most effective dose of the drug combination, while Phase 2 will evaluate how well the treatment works in shrinking tumors.

Description

The study is divided into two phases. In Phase 1b, researchers will test different doses of AsiDNA combined with Olaparib to find the safest and most effective dose for patients with recurrent ovarian, breast, or prostate cancer. This phase will help determine the best dose to use in the next phase of the study.

In Phase 2, the focus will be on how well the combination of AsiDNA and Olaparib works in treating patients with these types of cancer. Participants will receive AsiDNA through an IV infusion along with Olaparib. The goal is to see if this combination can help shrink tumors in patients whose cancer has returned after previous treatments with PARP inhibitors.

Eligible participants will include those with recurrent ovarian cancer, breast cancer, or prostate cancer that has not responded to or has progressed after previous treatments. The study aims to provide new insights into the potential benefits of combining AsiDNA with Olaparib for these patients.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older.
  • Must have signed a consent form to participate.
  • Phase 1b: Patients with advanced or metastatic ovarian, breast, or prostate cancer that has worsened after standard treatments or who cannot tolerate standard treatments.
  • Phase 2: Patients with:
    • Ovarian Cancer: Women with relapsed high-grade ovarian, fallopian tube, or primary peritoneal cancer, with at least 6 months since last platinum-based chemotherapy.
    • Breast Cancer: Recurrent breast cancer with advanced or metastatic disease, documented hormone receptor status, and progression on prior endocrine therapy. HER2 positive patients are not eligible.
    • Prostate Cancer: Advanced metastatic prostate cancer with progression despite medical or surgical castration, confirmed by specific criteria.
  • All Phase 2 participants must have shown progression on previous PARP inhibitor therapy.

Exclusion Criteria

  • Any anti-cancer drug therapy within 28 days before starting the study, except for PARP inhibitors.
  • Treatment with investigational drugs within 28 days before the study.
  • Recent radiation therapy within four weeks before the study.
  • Use of certain medications that affect the liver enzyme CYP3A within specified timeframes before starting Olaparib.
  • Other cancers within the last 5 years, except for certain skin or cervical cancers.
  • Conditions that prevent swallowing or absorbing oral medication.
  • Uncontrolled brain metastases, unless previously treated and stable.
  • Persistent side effects from previous cancer treatments, except for hair loss.

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