A Phase 1/2 interventional study of AsiDNA and Olaparib in Metastatic Castration-resistant Prostate Cancer, Recurrent Epithelial Ovarian Cancer and Breast Cancer, sponsored by Valerio Therapeutics. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Valerio Therapeutics · Phase 1/2, Interventional, and Treatment
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.
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.
1,617 studies on the registry are indexed under Carcinoma, Ovarian Epithelial; 246 are open to participants now.
This study's enrollment of 3 is below the median of 47 across 1,194 interventional studies indexed under Carcinoma, Ovarian Epithelial.
Browse Carcinoma, Ovarian Epithelial studies →Valerio Therapeutics is the lead sponsor of 25 studies on the registry; none are open to participants now.
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Phase 2: Participants with:
A. Ovarian Cancer:
i. 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.
B. Breast Cancer:
i. 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.
C. Prostate Cancer:
i. Histologically or cytologically confirmed adenocarcinoma of the prostate, CRPC.
ii. 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 observation of ≥2 new bone lesions since the initiation of last systemic therapy. iv. Surgically (bilateral orchiectomy) or medically castrated, with serum testosterone
Exclusion Criteria:
Three dose levels of AsiDNA delivered intravenously weekly in combination with Olaparib
Drug: AsiDNA · Drug: Olaparib
Recommended Phase 2 dose of AsiDNA delivered intravenously weekly in combination with Olaparib
Drug: AsiDNA · Drug: Olaparib
Recommended Phase 2 dose of AsiDNA delivered intravenously weekly in combination with Olaparib
Drug: AsiDNA · Drug: Olaparib
Recommended Phase 2 dose of AsiDNA delivered intravenously weekly in combination with Olaparib
Drug: AsiDNA · Drug: Olaparib
All patients will receive a loading dose of AsiDNA intravenously (D1, D2, D3) followed by weekly intravenous administrations in combination with Olaparib.
Olaparib is given orally in combination with AsiDNA
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)
Time frame: Baseline to Week 26
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
Time frame: Baseline to Week 26
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
Time frame: Baseline to Week 26
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
Time frame: Baseline to Week 26
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
Time frame: Baseline to Week 26
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
Time frame: Baseline to Week 26
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).
Time frame: Baseline to Week 26
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.
Time frame: Baseline to Week 52
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.
Time frame: Baseline to Week 26
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.
Time frame: Baseline to Week 26
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.
Time frame: Baseline to Week 26
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.
Time frame: Baseline to Week 52
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.
Time frame: Baseline to Week 52
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.
Time frame: Baseline to Week 52
Plan to share: No
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Carcinoma, Ovarian Epithelial→
Valerio Therapeutics