Cirtuvivint/Olaparib in Breast Cancer Susceptibility Gene/Homologous Recombination Deficiency Platinum Resistant Ovarian Cancer

Last updated: January 7, 2026
Sponsor: University of Colorado, Denver
Overall Status: Active - Recruiting

Phase

1

Condition

Fallopian Tube Cancer

Pelvic Cancer

Ovarian Cysts

Treatment

Cirtuvivint

Olaparib

Clinical Study ID

NCT06856499
24-1749.cc
NCI-2024-09126
R01CA288651-01
  • Ages > 18
  • Female

Study Summary

The purpose of this study is to learn about the safety and tolerability of Cirtuvivint in combination with Olaparib in platinum resistant ovarian cancer. The study also aims to determine the recommended dose of the combination therapy.

If a participant is a good fit for the study, and they enroll in the study, they will:

  • Visit the clinic often at the beginning of the study for physical exams, blood draws, vital signs, and other study and routine care procedures. After the first two months participants will visit the clinic every 28 days.

  • Take the study medications, Cirtuvivint and Olaparib. Participants will take Olaparib every day. Participants will either take Cirtuvivint 5 days per week or 2 days per week.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Provision to sign and date the consent form.

  2. Stated willingness to comply with all study procedures and be available for theduration of the study.

  3. Woman aged ≥18 years of age

  4. Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOGPS) of 0 1 or 2

  5. Patients must have a confirmed diagnosis of high-grade serous or endometrioidepithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer

  6. Patients must have platinum-resistant disease defined as radiographic progressionless than 6 months from last dose of most recent platinum therapy

  7. Patients must have measurable disease by defined RECIST 1.1 criteria

  8. Prior anticancer therapy:

  • Patients must have received at least one prior platinum-based chemotherapyregimen

  • Patients may not have received more than 3 prior lines of systemic therapy

  • Neoadjuvant +/- adjuvant therapies are considered 1 line of therapy

  • Maintenance therapy (eg, Bevacizumab, PARP inhibitors) will be considered partof preceding line of therapy (ie, not counted independently)

  • Therapy changed due to toxicity in the absence of progression will beconsidered part of the same line (ie, not counted independently)

  • Hormonal therapy will be counted as a separate line of therapy unless it wasgiven as maintenance

  • Prior radiation is allowed and is not considered a line of treatment

  1. Patients must have had testing for BRCA mutation (tumor or germline) and tumor HRDtesting, and have been positive for one and/or the other.

  2. Patients must have received a prior PARP inhibitor as either treatment ormaintenance therapy

  3. Patients must have adequate hematologic, liver, and kidney function as defined as:

  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (1500/µL)

  • Platelet count ≥ 100 x 109/L (100,000 µL)

  • Hemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days

  • Serum creatinine ≤ 1.5 x upper limit of normal (ULN)

  • Patients must have creatinine clearance estimated of ≥51 mL/min using theCockcroft-Gault equation or based on a 24 hour urine test

  • Aspartate aminotransferase (AST)(Serum Glutamic Oxaloacetic Transaminase (SGOT)) and alanine aminotransferase (ALT) (Serum Glutamic PyruvateTransaminase (SGPT)) ≤ 2.5 x ULN unless liver metastases are present in whichcase they must be ≤ 5x ULN

  • Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbertsyndrome are eligible if total bilirubin < 3.0 x ULN)

  • Serum albumin ≥ 2 g/dL

  1. Patients with a prior or concurrent malignancy whose natural history or treatmentdoes not have the potential to interfere with the safety or efficacy assessment ofthe investigational regimen are eligible for this trial.

  2. Ability to understand and the willingness to sign a written informed consentdocument. Participants with impaired decision-making capacity (IDMC) who have alegally-authorized representative (LAR) and/or family member available will also beeligible.

Exclusion

Exclusion Criteria:

  1. Patients with clear cell, mucinous, sarcomatous, low grade/borderline, germ cell, orsex-cord stromal type ovarian tumor

  2. Patients with platinum refractory disease as defined by those who have progressedduring or within 4 weeks of receiving platinum-based therapy

  3. Patients receiving any systemic chemotherapy or radiotherapy (except for palliativereasons) within 3 weeks prior to study treatment

  4. Patients with myelodysplastic syndrome/acute myeloid leukemia or with featuressuggestive of myelodysplastic syndrome/acute myeloid leukemia.

  5. Patients considered a poor medical risk due to a serious, uncontrolled medicaldisorder, non-malignant systemic disease or active, uncontrolled infection. Examplesinclude, but are not limited to:

  • Uncontrolled major seizure disorder

  • Unstable spinal cord compression

  • Any psychiatric disorder that prohibits obtaining informed consent.

  • Any other concurrent infectious disease requiring IV antibiotics within 2 weeksprior to the first dose of therapy

  1. Patients with clinically significant cardiac disease including, but not limited to,any of the following
  • Myocardial infarction ≤ 6 months prior to first dose

  • Uncontrolled ventricular arrhythmia, recent (within 3 months)

  • Superior vena cava syndrome

  • Unstable angina pectoris

  • Uncontrolled congestive heart failure (New York Heart Association > class II)

  • Uncontrolled ≥ Grade 3 hypertension (per CTCAE)

  • Uncontrolled cardiac arrhythmias

  1. Patients with a history of hemorrhagic or ischemic stroke within 6 months prior toenrollment

  2. Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)

  3. Persistent toxicities (>/= Common Terminology Criteria for Adverse Event (CTCAE)grade 2) caused by previous cancer therapy, excluding alopecia or peripheral sensoryneuropathy

  4. Patients with duodenal stent or other GI disorder/defect that would interfere withabsorption of oral medication o Includes patients unable to swallow orally administered medication and patientswith gastrointestinal disorders likely to interfere with absorption of the studymedication

  5. Patients with known untreated or symptomatic central nervous system (CNS) metastases

  6. Prior known hypersensitivity reaction to study drugs and/or any of their excipients

  7. Minor or major surgical procedure within 2 weeks of starting study treatment andpatients must have recovered from any effects of any major surgery.

  8. Inability to comply with study and follow-up procedures

  9. Patients deemed otherwise clinically unfit for clinical trial per investigatorsdiscretion.

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Cirtuvivint
Phase: 1
Study Start date:
December 08, 2025
Estimated Completion Date:
July 31, 2029

Study Description

This trial is a non-comparative phase I combination trial with the goal of determining the safety and RP2D of cirtuvivint when given orally daily (5 days on 2 days off) combined with olaparib given orally BID (continuously) for 28 day cycles, and of cirtuvivint when given orally daily (2 days on 5 days off) combined with olaparib given orally BID (continuously) for 28 day cycles. Patients will enter the two cohorts in alternating fashion by time of enrollment. The patient population will be women with platinum resistant high grade serous or endometrioid epithelial ovarian cancer who are germline or somatic BRCA/HRD positive. Due to potential survival detriment of late line PARP inhibition, patients will be limited to no more than 3 prior lines of therapy. Olaparib will be dosed at the standard recommended dose of 300mg BID and adjusted appropriately for known adverse events.

Connect with a study center

  • CU Medicine Clinics

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Universtiy of Colorado Hospital

    Aurora, Colorado 80045
    United States

    Site Not Available

  • CU Medicine Clinics

    Aurora 5412347, Colorado 5417618 80045
    United States

    Active - Recruiting

  • Universtiy of Colorado Hospital

    Aurora 5412347, Colorado 5417618 80045
    United States

    Active - Recruiting

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