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Metastatic Castration-resistant Prostate CancerPhase 1/2NCT05700669

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

A Phase 1/2 study testing AsiDNA and Olaparib in people with Metastatic Castration-resistant Prostate Cancer and Recurrent Epithelial Ovarian Cancer, run by Valerio Therapeutics at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AsiDNA and Olaparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
20 Feb 2023to 31 Oct 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female participants aged ≥18 years (no upper limit of age) at the time of consent signature.
  • Voluntarily signed written informed consent form (ICF) before performance of any study related screening procedures.
  • Phase 1b: Participants with advanced or metastatic ovarian, breast, or prostate cancer that have had disease progression after treatment with available therapies that are known to confer clinical benefit or are intolerant to or ineligible for standard treatment.
  • Phase 2: Participants with:
  • Ovarian Cancer:
  • Female participants with histologically diagnosed relapsed high-grade serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer. ii. Participants must have ≥6 months elapsed since last platinum-based chemotherapy regimen.
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  • Breast Cancer:
  • Histologically or cytologically confirmed recurrent breast cancer. ii. Advanced stage, metastatic disease as documented by imaging. iii. Participants must have documented status of ER, PR, and Human epidermal growth factor receptor 2 (HER2) according to ASCOCAP criteria prior to study entry. Participants must have had a biopsy to confirm hormone receptor status in the metastatic setting prior to study entry. Note: Participants with hormone receptor-positive (estrogen and/or progesterone receptor-positive) disease must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy. Endocrine therapy must have been completed at least 7 days before study treatment. iv. Participants with HER2 positive disease are not eligible for enrollment. v. Participants with ER+ tumors should have progressed on prior CDK4/6 inhibitors (in addition to hormonal therapy) to be eligible. vi. Participants with TNBC should have received sacituzumab prior to study enrollment.
  • Prostate Cancer:
  • Histologically or cytologically confirmed adenocarcinoma of the prostate, CRPC.
  • Advanced-stage, metastatic prostate cancer disease documented by soft tissue disease (per RECIST 1.1) by computerized tomography (CT)/ magnetic resonance imaging (MRI) imaging. iii. Progressive disease in the setting of medical or surgical castration (ie, CRPC) by
  • PCWG3 criteria for study entry:
  • Evidence of disease progression by rising Prostate-specific antigen (PSA), or
  • Soft tissue progression per RECIST 1.1, or
  • Evidence of disease progression by observation of ≥2 new bone lesions since the initiation of last systemic therapy. iv. Surgically (bilateral orchiectomy) or medically castrated, with serum testosterone
  • 50 ng/dL (≤1.73 nmol/L) at screening. v. Medically castrated participants must be willing to continue gonadotropin- releasing hormone (GnRH) analog or antagonist for the duration of study treatment.
  • All participants in Phase 2 must have documented progression (clinical or radiographic) on PARPi.

Who cannot join

  • Any systemic anti-tumor-directed drug therapy within 28 days or 5 times the elimination half life (whichever is shorter) before study treatment, except for PARPi.
  • Treatment with investigational drugs within 28 days before first study drug administration.
  • Radical radiation therapy within four weeks prior to the first dose of study treatment or received local palliative radiation therapy for bone metastases within two weeks of the first dose of study treatment.
  • Concomitant use of known strong cytochrome P450 (CYP) 3A inhibitors (eg, itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg, ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is two weeks.
  • Concomitant use of known strong (eg, phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (eg, bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is five weeks for enzalutamide or phenobarbital and three weeks for other agents.
  • Other malignancy within the last 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix, and in situ breast cancer.
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  • Participant has a condition which precludes the swallowing or absorption of an oral medication.
  • Participants with symptomatic uncontrolled brain metastases. Participants with previously treated brain metastases may participate provided they are stable and are on stable or tapering doses of steroids for at least 7 days prior to first dose of study treatment.
  • Participant with persistent toxicities (≥ CTCAE grade 2) caused by previous cancer therapy, excluding alopecia.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Next Oncology

    San Antonio, Texas, 78229

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Being tested
AsiDNA, Olaparib
Medical subject headings
Carcinoma, Ovarian Epithelial, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AsiDNADrug

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

  • OlaparibDrug

    Olaparib is given orally in combination with AsiDNA

Study groups in NCT05700669
Study groupRoleWhat they receive
Dose EscalationExperimentalThree dose levels of AsiDNA delivered intravenously weekly in combination with Olaparib
Receives: Drug: AsiDNA; Drug: Olaparib
Dose Expansion: Recurrent Epithelial Ovarian Cancer CohortExperimentalRecommended Phase 2 dose of AsiDNA delivered intravenously weekly in combination with Olaparib
Receives: Drug: AsiDNA; Drug: Olaparib
Dose Expansion: Metastatic Castration-resistant Prostate Cancer CohortExperimentalRecommended Phase 2 dose of AsiDNA delivered intravenously weekly in combination with Olaparib
Receives: Drug: AsiDNA; Drug: Olaparib
Dose Expansion: Recurrent Breast Cancer CohortExperimentalRecommended Phase 2 dose of AsiDNA delivered intravenously weekly in combination with Olaparib
Receives: Drug: AsiDNA; Drug: Olaparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    • Dose-limiting toxicities (DLTs) as determined by adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE 5.0)

    Measured: Baseline to Week 26

  2. 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.

    • Dose-limiting toxicities (DLTs) as determined by physical examination

    Measured: Baseline to Week 26

  3. 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.

    • Dose-limiting toxicities (DLTs) as determined vital signs

    Measured: Baseline to Week 26

  4. 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.

    • Dose-limiting toxicities (DLTs) as determined by ECG

    Measured: Baseline to Week 26

  5. 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.

    • Dose-limiting toxicities (DLTs) as determined by clinical laboratory tests

    Measured: Baseline to Week 26

  6. 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.

    • Dose-limiting toxicities (DLTs) as determined by Eastern Cooperative Oncology Group (ECOG) performance status

    Measured: Baseline to Week 26

  7. 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.

    Pharmacologically active dose (PAD) and/or Maximum Tolerated Dose (MTD).

    Measured: Baseline to Week 26

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

    Objective Response Rate (ORR) defined as the percentage of participants achieving a confirmed complete response (CR) or partial response (PR) based on Investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria guidelines.

    Measured: Baseline to Week 52

Secondary outcomes (6)

  1. 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.

    • Safety PK parameters: total exposure including Area under the plasma concentration-time curve (AUC)0-24.

    Measured: Baseline to Week 26

  2. 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.

    • Safety PK parameters: total exposure including AUC0-last.

    Measured: Baseline to Week 26

  3. 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.

    • Safety PK parameters: total exposure including Cmax.

    Measured: Baseline to Week 26

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

    • Duration of Response: time from earliest date of disease response (CR or PR) until earliest date of disease progression, or death, whichever occurs first.

    Measured: Baseline to Week 52

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

    • Disease Control Rate: the proportion of participants in whom a CR or PR or stable disease is observed as best overall response.

    Measured: Baseline to Week 52

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

    • Progression Free Survival: time from start of treatment until the first documented radiographic progressive disease or death, whichever occurs first.

    Measured: Baseline to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2023
  2. Study start20 Feb 2023
  3. Primary completion31 Oct 2023
  4. Study completion31 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Dose Escalation followed by dose expansion
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05700669
Sponsor's protocol ID
OX2022-203-01
Status last verified
Sep 2024
First submitted
22 Dec 2022
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AsiDNA and Olaparib in people with Metastatic Castration-resistant Prostate Cancer and Recurrent Epithelial Ovarian Cancer, run by Valerio Therapeutics at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05700669.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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Clinical Trial NCT05700669 | AzTrials