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DNA Repair Inhibitor

AsiDNA + Olaparib for Recurrent Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Onxeo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

iv. Surgically (bilateral orchiectomy) or medically castrated, with serum testosterone 50 ng/dL (≤1.73 nmol/L) at screening

iii. Progressive disease in the setting of medical or surgical castration (ie, CRPC) by PCWG3 criteria for study entry

Must not have

Concomitant use of known strong or moderate CYP3A inducers. The required washout period prior to starting olaparib is five weeks for enzalutamide or phenobarbital and three weeks for other agents

Participant with persistent toxicities (≥ CTCAE grade 2) caused by previous cancer therapy, excluding alopecia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 52

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug combo to treat ovarian, breast and prostate cancer that has worsened despite PARP inhibitor therapy. Researchers will look at how safe and effective it is.

Who is the study for?

Adults with recurrent ovarian, breast, or prostate cancer that's worsened after treatment or who can't tolerate standard treatments. They must have tried PARP inhibitors before and for prostate cancer, be medically castrated. Breast cancer patients need known ER/PR/HER2 status; HER2 positive and those without prior sacituzumab aren't eligible.

What is being tested?

The trial is testing AsiDNA combined with Olaparib in people with certain types of recurring cancers to see if it's safe and works against tumors. It has two parts: Phase 1b finds the right dose and Phase 2 tests its effectiveness at that dose.

What are the potential side effects?

Potential side effects include issues from taking oral medication, reactions related to drug metabolism by the liver (CYP3A interactions), worsening of previous persistent cancer therapy side effects except hair loss, and complications from brain metastases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have undergone treatment to lower my testosterone levels below 50 ng/dL.

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My prostate cancer has worsened despite treatment to lower testosterone.

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My cancer has spread to other parts of my body, as shown by scans.

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My prostate cancer is confirmed to be advanced and resistant to hormonal therapy.

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My prostate cancer has spread and is visible on scans.

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My ER+ tumor has worsened despite previous treatments with CDK4/6 inhibitors.

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My cancer's ER, PR, and HER2 status are documented according to ASCOCAP criteria.

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My breast cancer has come back and was confirmed by a lab test.

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I am a woman with a specific type of ovarian, fallopian tube, or peritoneal cancer that has come back.

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I am willing to continue hormone therapy for prostate cancer during the study.

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My advanced cancer (ovarian, breast, prostate) has worsened after all known beneficial treatments.

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My cancer is not HER2 positive.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have stopped taking certain strong medications for the required time before starting olaparib.

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I have lasting side effects from cancer treatment, but not hair loss.

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I haven't had major radiation therapy in the last 4 weeks or bone-targeted radiation in the last 2 weeks.

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I cannot swallow or absorb pills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Phase 2: Evaluate the anti-tumor activity of AsiDNA in combination with olaparib.

Secondary study objectives

Phase 1b: Assess the pharmacokinetics (PK) of AsiDNA when administered in combination with olaparib in participants with advanced and/or metastatic ovarian, breast, or prostate cancer.

Phase 2: Evaluate additional parameters of efficacy of AsiDNA in combination with olaparib.