Endometrioid Ovarian CancerPhase 1NCT06856499
Cirtuvivint/Olaparib in Breast Cancer Susceptibility Gene/Homologous Recombination Deficiency Platinum Resistant Ovarian Cancer
A Phase 1 study testing Cirtuvivint and Olaparib in people with Endometrioid Ovarian Cancer and Primary Peritoneal Cancer, run by University of Colorado, Denver at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrioid Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer
- What is being tested?
- Cirtuvivint and Olaparib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Dec 2025to 1 Sep 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision to sign and date the consent form.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Woman aged ≥18 years of age
- Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 1 or 2
- Patients must have a confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
- Patients must have platinum-resistant disease defined as radiographic progression less than 6 months from last dose of most recent platinum therapy
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- Patients must have measurable disease by defined RECIST 1.1 criteria
- Prior anticancer therapy:
- Patients must have received at least one prior platinum-based chemotherapy regimen
- 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 part of preceding line of therapy (ie, not counted independently)
- Therapy changed due to toxicity in the absence of progression will be considered part of the same line (ie, not counted independently)
- Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance
- Prior radiation is allowed and is not considered a line of treatment
- Patients must have had testing for BRCA mutation (tumor or germline) and tumor HRD testing, and have been positive for one and/or the other.
- Patients must have received a prior PARP inhibitor as either treatment or maintenance therapy
- 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 the Cockcroft-Gault equation or based on a 24 hour urine test
- Aspartate aminotransferase (AST)(Serum Glutamic Oxaloacetic Transaminase (SGOT)) and alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x ULN unless liver metastases are present in which case they must be ≤ 5x ULN
- Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin < 3.0 x ULN)
- Serum albumin ≥ 2 g/dL
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally-authorized representative (LAR) and/or family member available will also be eligible.
Who cannot join
- Patients with clear cell, mucinous, sarcomatous, low grade/borderline, germ cell, or sex-cord stromal type ovarian tumor
- Patients with platinum refractory disease as defined by those who have progressed during or within 4 weeks of receiving platinum-based therapy
- Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment
- Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of myelodysplastic syndrome/acute myeloid leukemia.
- Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to:
- Uncontrolled major seizure disorder
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- Unstable spinal cord compression
- Any psychiatric disorder that prohibits obtaining informed consent.
- Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to the first dose of therapy
- 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
- Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment
- Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)
- Persistent toxicities (>/= Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia or peripheral sensory neuropathy
- Patients with duodenal stent or other GI disorder/defect that would interfere with absorption of oral medication
- o Includes patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication
- Patients with known untreated or symptomatic central nervous system (CNS) metastases
- Prior known hypersensitivity reaction to study drugs and/or any of their excipients
- Minor or major surgical procedure within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
- Inability to comply with study and follow-up procedures
- Patients deemed otherwise clinically unfit for clinical trial per investigators discretion.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
CU Medicine Clinics
Aurora, Colorado, 80045
Evamaria Kent Bravo, MS, 303-724-0131, evamaria.kentbravo@cuanschutz.edu
- Recruiting
Universtiy of Colorado Hospital
Aurora, Colorado, 80045
Kailey Palmen, 303-724-2435, kailey.palmen@cuanschutz.edu
About this study
Official title: Phase I Evaluation of Combination CLK/DYRK (Cirtuvivint) Inhibition With PARP Inhibition (Olaparib) in BRCA/HRD Platinum Resistant Ovarian Cancer
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.
Read the detailed 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.
- Being tested
- Cirtuvivint, Olaparib
- Medical subject headings
- Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CirtuvivintDrug
Cirtuvivint (SM08502) is a first in class pan CDC-like kinase (CLK) and dual specificity tyrosine kinase (DYRK) inhibitor with suspected multiple anti-tumor mechanisms of action, including Wnt inhibition.
OlaparibDrug
Also called Lynparza
NCI Definition - A small molecule inhibitor of the nuclear enzyme poly(ADP-ribose) polymerase (PARP) with potential chemosensitizing, radiosensitizing, and antineoplastic activities. Olaparib selectively binds to and inhibits PARP, inhibiting PARP-mediated repair of single strand DNA breaks; PARP inhibition may enhance the cytotoxicity of DNA-damaging agents and may reverse tumor cell chemoresistance and radioresistance. PARP catalyzes post-translational ADP-ribosylation of nuclear proteins and can be activated by single-stranded DNA breaks.
| Study group | Role | What they receive |
|---|---|---|
| Dose Regimen 1 | Experimental | Patients on Dose Regimen 1 will take 300mg PO BID olaparib in combination with 80mg PO cirtuvivint for 5 days on and 2 days off. Receives: Drug: Cirtuvivint; Drug: Olaparib |
| Dose Regimen 2 | Experimental | Patients on Dose Regimen 2 will take 300 mg PO BID olaparib in combination with 120 mg PO cirtuvivint for 2 days on and 5 days off Receives: Drug: Cirtuvivint; Drug: Olaparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the Safety of Combination Cirtuvivint with Olaparib
To determine the safety and tolerability of combination Cirtuvivint and Olaparib in BRCA/HRD platinum resistant ovarian cancer as evaluated by CTCAE v5.0 criteria.
Measured: 6 months
Determine the recommended Phase 2 Dose of Cirtuvivint with Olaparib
To determine the recommended Phase 2 Dose (RP2D) and regimen of the combination therapy
Measured: 6 months
Secondary outcomes (4)
Evaluate the Cmax (peak plasma concentration) of Cirtuvivint when given in combination with olaparib
To evaluate the Cmax (peak plasma concentration) of Cirtuvivint when given in combination with olaparib
Measured: 3 years
Evaluate the AUC (Area under the curve for plasma concentration) of Cirtuvivint when given in combination with olaparib
To evaluate the AUC (Area under the curve for plasma concentration) of Cirtuvivint when given in combination with olaparib
Measured: 3 years
Evaluate the half-life (elimination half-life in plasma) of Cirtuvivint when given in combination with olaparib
To evaluate the half-life (elimination half-life in plasma) of Cirtuvivint when given in combination with olaparib
Measured: 3 years
Evaluate CL (drug clearance) of Cirtuvivint when given in combination with olaparib
To evaluate CL (drug clearance) of Cirtuvivint when given in combination with olaparib
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start8 Dec 2025
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrioid Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Bradley Corr, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856499
- Sponsor's protocol ID
- 24-1749.cc
- Other IDs
- R01CA288651-01, NCI-2024-09126
- Status last verified
- Jul 2026
- First submitted
- 13 Jan 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Evaluation of Combination CLK/DYRK (Cirtuvivint) Inhibition With PARP Inhibition (Olaparib) in BRCA/HRD Platinum Resistant Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06856499
- Acronym / sponsor ID
- 24-1749.cc
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Regimen 1 | Experimental | Drug: Cirtuvivint, Drug: OlaparibPatients on Dose Regimen 1 will take 300mg PO BID olaparib in combination with 80mg PO cirtuvivint for 5 days on and 2 days off. |
| Dose Regimen 2 | Experimental | Drug: Cirtuvivint, Drug: OlaparibPatients on Dose Regimen 2 will take 300 mg PO BID olaparib in combination with 120 mg PO cirtuvivint for 2 days on and 5 days off |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Provision to sign and date the consent form.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Woman aged ≥18 years of age
- Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 1 or 2
- Patients must have a confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
Key exclusion criteria (27 listed)
- Patients with clear cell, mucinous, sarcomatous, low grade/borderline, germ cell, or sex-cord stromal type ovarian tumor
- Patients with platinum refractory disease as defined by those who have progressed during or within 4 weeks of receiving platinum-based therapy
- Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment
- Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of myelodysplastic syndrome/acute myeloid leukemia.
- Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CirtuvivintCirtuvivint (SM08502) is a first in class pan CDC-like kinase (CLK) and dual specificity tyrosine kinase (DYRK) inhibitor with suspected multiple anti-tumor mechanisms of action, including Wnt inhibition. | Drug | Dose Regimen 1, Dose Regimen 2 |
| OlaparibAlso: LynparzaNCI Definition - A small molecule inhibitor of the nuclear enzyme poly(ADP-ribose) polymerase (PARP) with potential chemosensitizing, radiosensitizing, and antineoplastic activities. Olaparib selectively binds to and inhibits PARP, inhibiting PARP-mediated repair of single strand DNA breaks; PARP inhibition may enhance the cytotoxicity of DNA-damaging agents and may reverse tumor cell chemoresistance and radioresistance. PARP catalyzes post-translational ADP-ribosylation of nuclear proteins and can be activated by single-stranded DNA breaks. | Drug | Dose Regimen 1, Dose Regimen 2 |
Primary outcome
Determine the Safety of Combination Cirtuvivint with Olaparib
Time frame: 6 months
To determine the safety and tolerability of combination Cirtuvivint and Olaparib in BRCA/HRD platinum resistant ovarian cancer as evaluated by CTCAE v5.0 criteria.
Determine the recommended Phase 2 Dose of Cirtuvivint with Olaparib
Time frame: 6 months
To determine the recommended Phase 2 Dose (RP2D) and regimen of the combination therapy
4 secondary outcomes
Evaluate the Cmax (peak plasma concentration) of Cirtuvivint when given in combination with olaparib
Time frame: 3 years
Evaluate the AUC (Area under the curve for plasma concentration) of Cirtuvivint when given in combination with olaparib
Time frame: 3 years
Evaluate the half-life (elimination half-life in plasma) of Cirtuvivint when given in combination with olaparib
Time frame: 3 years
Evaluate CL (drug clearance) of Cirtuvivint when given in combination with olaparib
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bradley Corr principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cirtuvivint and Olaparib in people with Endometrioid Ovarian Cancer and Primary Peritoneal Cancer, run by University of Colorado, Denver at 2 sites 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 28 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kailey Palmen, BA (303-724-2435, kailey.palmen@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the Safety of Combination Cirtuvivint with Olaparib (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2026.