140 Participants Needed

ZN-c3 for Ovarian Cancer

Recruiting at 13 trial locations
PD
KB
Overseen ByK-Group, Beta, Inc., a subsidiary of Zentalis Pharmaceuticals
Age: 18+
Sex: Female
Trial Phase: Phase 1
Sponsor: K-Group Beta
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of ZN-c3 in combination with other drugs.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug ZN-c3, Azenosertib, for ovarian cancer?

The research highlights the challenges in treating platinum-resistant ovarian cancer and suggests that novel treatments, including those targeting specific genetic changes, may offer promising results. Although ZN-c3, Azenosertib is not directly mentioned, the focus on new therapies and genetic targets in ovarian cancer suggests potential for drugs like ZN-c3, which may work on similar principles.12345

Who Is on the Research Team?

PP

Philippe Pultar, MD

Principal Investigator

K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

Are You a Good Fit for This Trial?

This trial is for women over 18 with high-grade serous ovarian, fallopian tube, or peritoneal carcinoma that's resistant to platinum-based therapy. They must have had 1-2 prior treatments and measurable disease. Participants need proper organ function, a negative pregnancy test, and agree to use contraception.

Inclusion Criteria

I am a woman over 18 or the legal adult age in my country.
My blood and organs are functioning well.
I can take care of myself and do some daily activities.
See 7 more

Exclusion Criteria

I am not pregnant, breastfeeding, or have a positive pregnancy test.
I do not have another cancer that is spreading or needs treatment.
Your ECG shows a specific measurement called corrected QT interval (QTcF) that is longer than 480 milliseconds, unless you have certain heart conditions that affect this measurement.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ZN-c3 in combination with chemotherapy or bevacizumab to evaluate safety, tolerability, and clinical activity

40 months
Multiple visits per cycle, each cycle is 28 days for PLD or paclitaxel, and 21 days for carboplatin, gemcitabine, or bevacizumab

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ZN-c3
Trial Overview The study tests ZN-c3 in combination with other cancer drugs (Carboplatin, Pegylated liposomal doxorubicin, Paclitaxel, Gemcitabine) on patients with platinum-resistant ovarian cancer. It aims to assess safety, tolerability and preliminary effectiveness of the drug mix.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Group I: Combination with paclitaxelExperimental Treatment2 Interventions
Group II: Combination with gemcitabineExperimental Treatment2 Interventions
Group III: Combination with carboplatinExperimental Treatment2 Interventions
Group IV: Combination with bevacizumabExperimental Treatment2 Interventions
Group V: Combination with PLDExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

K-Group Beta

Lead Sponsor

Trials
6
Recruited
670+

K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

Lead Sponsor

Trials
8
Recruited
740+

Published Research Related to This Trial

The study identified the overexpression of the IL6-STAT3-HIF pathway in ovarian clear cell adenocarcinoma (OCCA) tumors, suggesting it as a potential therapeutic target, especially since this pathway is linked to poor outcomes in patients.
Two patients with chemotherapy-resistant OCCA showed significant clinical responses to sunitinib treatment, indicating that this drug may be a promising option for patients with this specific type of ovarian cancer.
IL6-STAT3-HIF signaling and therapeutic response to the angiogenesis inhibitor sunitinib in ovarian clear cell cancer.Anglesio, MS., George, J., Kulbe, H., et al.[2022]
The study identified two distinct molecular subgroups of high-grade serous epithelial ovarian cancers (EOCs) based on gene expressions related to POSTN/TGFBI and ESR1/WT1, which are associated with significantly different overall survival rates (30 months vs. 49 months).
BRCA germline mutations were more common in the ESR1/WT1 subgroup, suggesting that this subgroup may have specific therapeutic targets and prognostic implications for treatment strategies.
POSTN/TGFBI-associated stromal signature predicts poor prognosis in serous epithelial ovarian cancer.Karlan, BY., Dering, J., Walsh, C., et al.[2022]
The standard treatment for platinum-resistant ovarian cancer involves non-platinum chemotherapy, with weekly paclitaxel showing the greatest benefits, but overall response rates remain modest, highlighting the need for improved therapies.
Recent trials indicate that while combination treatments with antiangiogenics have improved outcomes, there is still a lack of reliable biomarkers to predict treatment response, emphasizing the importance of thoughtful clinical trial designs and the exploration of novel therapies.
Overcoming the challenges of drug development in platinum-resistant ovarian cancer.Eskander, RN., Moore, KN., Monk, BJ., et al.[2023]

Citations

IL6-STAT3-HIF signaling and therapeutic response to the angiogenesis inhibitor sunitinib in ovarian clear cell cancer. [2022]
POSTN/TGFBI-associated stromal signature predicts poor prognosis in serous epithelial ovarian cancer. [2022]
Overcoming the challenges of drug development in platinum-resistant ovarian cancer. [2023]
Histo-genomic stratification reveals the frequent amplification/overexpression of CCNE1 and BRD4 genes in non-BRCAness high grade ovarian carcinoma. [2019]
Clinicopathologic Impact of NANOG, ZEB1, and EpCAM Biomarkers on Prognosis of Serous Ovarian Carcinoma. [2023]
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