RecruitingPhase 1NCT06856499

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

Phase I Evaluation of Combination CLK/DYRK (Cirtuvivint) Inhibition With PARP Inhibition (Olaparib) in BRCA/HRD Platinum Resistant Ovarian Cancer


Sponsor

University of Colorado, Denver

Enrollment

50 participants

Start Date

Dec 8, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — cirtuvivint (a WNT pathway inhibitor) and olaparib (a PARP inhibitor) — for women with ovarian cancer that has a BRCA gene mutation or homologous recombination deficiency, and whose cancer has become resistant to platinum-based chemotherapy. **You may be eligible if...** - You are a woman aged 18 or older - You have high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer - Your cancer is platinum-resistant (progressed less than 6 months after your last platinum treatment) - You have a BRCA gene mutation or evidence of homologous recombination deficiency (HRD) - You have at least one prior platinum-based chemotherapy - You have measurable disease on imaging and a general health score (ECOG) of 0–2 **You may NOT be eligible if...** - You have a clear cell, mucinous, or low-grade ovarian tumor - Your cancer is platinum-refractory (progressed during or within 4 weeks of platinum treatment) - You have received chemotherapy or radiation in the past 3 weeks - You have signs of myelodysplastic syndrome or acute myeloid leukemia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCirtuvivint

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.

DRUGOlaparib

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.


Locations(2)

CU Medicine Clinics

Aurora, Colorado, United States

Universtiy of Colorado Hospital

Aurora, Colorado, United States

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NCT06856499


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