ClinicalTrials.gg
RecruitingNCT04516447MUIRUpdated Nov 9, 2026

A Study of Azenosertib (ZN-c3) in Patients With Ovarian Cancer

A Phase 1 interventional study of Azenosertib and Carboplatin in Solid Tumor, Epithelial Ovarian Cancer and Fallopian Tube Cancer, sponsored by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc. Recruiting at 35 sites in 8 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2020; still recruiting 6 years later.
Updated Nov 9, 2026First site in FranceSite recruiting status changed+1 moreGo to Updates ↓

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Phase
Phase 1
Study type
Interventional
Enrollment
172
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 46 studies in Carcinoma, Ovarian Epithelial with a site in France — 10 open to participants now, 14 under way, 5 of them phase 3. Carcinoma, Ovarian Epithelial · France.

Planned enrollment
25th of 40
172 · median 245
Started
2020
with 1 other
Phase 1
7 of 46
2 open now
Primary completion
2028-06
later than 7 of 13 live
Registered
34th of 46
by date

Among the 46 studies in Carcinoma, Ovarian Epithelial with a site in France, this one is the 25th largest by planned enrollment of the 40 interventional ones that give a count, is one of 2 that started in 2020, is one of 7 in phase 1, reaches primary completion later than 7 of the 13 other live ones, and was the 34th registered.

Carcinoma, Ovarian Epithelial

798 studies on the registry are indexed under Carcinoma, Ovarian Epithelial; 102 are open to participants now.

Browse Carcinoma, Ovarian Epithelial studies →

Open to participants now

10 of the 46 studies in Carcinoma, Ovarian Epithelial with a site in France are open now. Recruiting first, the newest first:

4 more — sign in →

All 10 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 75 Carcinoma, Ovarian Epithelial studies recruiting now, 50 (67%) set no upper age limit and 12 (16%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

The full table on the hub →

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02

Study summary

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

Read the detailed description

This is a Phase 1b open-label, multicenter study evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of azenosertib (also known as ZN-c3) in combination with chemotherapy or bevacizumab. This study consists of 2 parts:

Part 1 (completed and no longer recruiting): Azenosertib in combination with chemotherapy Azenosertib was assessed in combination with chemotherapy in subjects with platinum-resistant advanced ovarian, peritoneal, or fallopian tube cancer.

Part 2: Azenosertib in combination with bevacizumab

  • Dose Escalation (completed and no longer recruiting): Azenosertib was assessed in combination with bevacizumab as first-line (1L) or second-line (2L) maintenance therapy in subjects with advanced ovarian, peritoneal, or fallopian tube cancer after platinum-based chemotherapy to determine a recommended dose for expansion.
  • Dose Expansion: Azenosertib will be assessed in combination with bevacizumab as 2L maintenance therapy in subjects with advanced ovarian, peritoneal, or fallopian tube cancer after platinum-based chemotherapy.
03

Conditions studied

  • Solid Tumor
  • Epithelial Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Cancer

Keywords

  • Solid Tumor
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

For Part 1:

  • or cytologically confirmed FIGO Stage III/IV high-grade serous or endometrioid ovarian, fallopian tube, or peritoneal carcinoma.
  • Subjects must have received 1 or 2 prior therapeutic regimens/ in the advanced or setting. At least one regimen must have contained cisplatin or carboplatin.
  • The disease must be platinum resistant (ie, the PFI must have been \< 6 months). Platinum disease (ie, PD during first-line platinum-based therapy) is allowed.

For Part 2 Dose Escalation:

Prior therapy:

  • Subjects must have received 6 cycles of platinum-based doublet chemotherapy in the 1L or 2L setting as their most recent therapy

Response to prior platinum therapy:

  1. In the 1L setting: Complete Response, Partial Response, or Stable Disease to platinum-based chemotherapy.
  2. In the 2L setting:

    1. Progressive Disease >183 days after receiving the last dose of platinum chemotherapy in the 1L setting,
    2. Complete Response, Partial Response, or Stable Disease to 2L platinum-based chemotherapy.

      • Adequate hematologic, and organ function

For Part 2 Dose Expansion:

  • Subjects must have at least 4 cycles of platinum-based chemotherapy in 2L and have Complete Response, Partial Response, or Stable Disease
  • Subjects must have progressed while on a PARP inhibitor for 1L maintenance Additional protocol-defined inclusion criteria may apply

Exclusion criteria

EXCLUSION CRITERIA:

  • Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderline ovarian tumor.
  • Subjects with carcinosarcomas (even if there is a serous component)
  • A serious illness or medical condition(s)
  • Subjects with active (uncontrolled, ) second or requiring therapy.

Additional protocol-defined exclusion criteria may apply

Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
172 participants (estimated)

Study arms

  • Experimental
    Part 1: Azenosertib + carboplatin

    Azenosertib in combination with carboplatin

    Drug: Azenosertib · Drug: Carboplatin

  • Experimental
    Part 1: Azenosertib + PLD

    Azenosertib in combination with pegylated liposomal doxorubicin (PLD)

    Drug: Azenosertib · Drug: Pegylated liposomal doxorubicin

  • Experimental
    Part 1: Azenosertib + paclitaxel

    Azenosertib in combination with paclitaxel

    Drug: Azenosertib · Drug: Paclitaxel

  • Experimental
    Part 1: Azenosertib + gemcitabine

    Azenosertib in combination with gemcitabine

    Drug: Azenosertib · Drug: Gemcitabine

  • Experimental
    Part 2: Azenosertib + bevacizumab

    Azenosertib in combination with bevacizumab

    Drug: Azenosertib · Biological: Bevacizumab

Interventions

06

What researchers measure

Primary outcomes

  1. Part 1: To investigate the safety and tolerability of azenosertib in combination with PLD, carboplatin, paclitaxel, or gemcitabine

    Incidence and severity of adverse events (AEs)

    Time frame: Through study completion, an average of 1 year

  2. Part 1: To identify the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of azenosertib in combination with PLD, carboplatin, paclitaxel, or gemcitabine

    Incidence and severity of dose-limiting toxicities (DLTs)

    Time frame: Through Cycle 1 (cycle is 28 days for PLD or paclitaxel, and 21 days for carboplatin, or gemcitabine)

  3. Part 2: To estimate the safety/tolerability of azenosertib in combination with bevacizumab

    Incidence and severity of adverse events (AEs) Incidence of dose interruptions, reductions, and discontinuations due to treatment-related AEs

    Time frame: Through study completion, an average of 1 year

  4. Part 2: To identify the recommended dose for Part 2 Dose Expansion

    Time frame: Through Cycle 1 (21 days)

07

Study locations

12 of 35 sites recruiting
  • Site 0264
    Aurora, Colorado 80045, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Site 0104
    Boston, Massachusetts 02215, United States
    Recruiting
  • Site 0111
    St Louis, Missouri 53110, United States
    Recruiting
  • Site 0173
    New York, New York 10029, United States
    Recruiting
  • Site 0259
    Durham, North Carolina 27710, United States
    Recruiting
  • Site 0191
    Providence, Rhode Island 02905, United States
    Recruiting
  • Site 0196
    Nashville, Tennessee 37203, United States
    Completed

    Not enrolling at this site — choose another above.

  • Site 0103
    Houston, Texas 77030, United States
    Recruiting
  • Site 2707
    South Brisbane, Queensland 4101, Australia
    Completed

    Not enrolling at this site — choose another above.

  • Site 2708
    Sunshine Coast, Queensland 4556, Australia
    Completed

    Not enrolling at this site — choose another above.

  • Site 2718
    Sunshine Coast, Queensland 4556, Australia
    Recruiting
  • Site 2709
    Adelaide, South Australia 5000, Australia
    Completed

    Not enrolling at this site — choose another above.

  • Site 2716
    Melbourne, Victoria 3121, Australia
    Recruiting
  • Site 2706
    Melbourne, Victoria 3144, Australia
    Completed

    Not enrolling at this site — choose another above.

  • Site 2705
    Nedlands, Western Australia 6009, Australia
    Completed

    Not enrolling at this site — choose another above.

  • Site 1001
    Banja Luka, 78000, Bosnia and Herzegovina
    Completed

    Not enrolling at this site — choose another above.

  • Site 1002
    Sarajevo, 71000, Bosnia and Herzegovina
    Completed

    Not enrolling at this site — choose another above.

  • Site 1003
    Tuzla, 75000, Bosnia and Herzegovina
    Completed

    Not enrolling at this site — choose another above.

  • Site 1202
    Panagyurishte, 4500, Bulgaria
    Completed

    Not enrolling at this site — choose another above.

  • Site 1201
    Sofia, 1632, Bulgaria
    Completed

    Not enrolling at this site — choose another above.

  • 3613
    Besançon, 25000, France
    Not yet recruiting
  • 3624
    Bordeaux, 33000, France
    Recruiting
  • 3601
    Dijon, 21000, France
    Recruiting
  • 3608
    Lyon, 69002, France
    Not yet recruiting
  • 3614
    Nantes, 44800, France
    Not yet recruiting
  • 3623
    Paris, 75020, France
    Not yet recruiting
  • 3604
    Paris, 94800, France
    Not yet recruiting
  • 3625
    Rennes, 35000, France
    Recruiting
  • 3611
    Strasbourg, 67000, France
    Not yet recruiting
  • 3603
    Toulouse, 311000, France
    Recruiting
  • Site 1401
    Tbilisi, 0112, Georgia
    Completed

    Not enrolling at this site — choose another above.

  • Site 1902
    Belgrade, 11080, Serbia
    Completed

    Not enrolling at this site — choose another above.

  • Site 2901
    Busan, South Korea
    Completed

    Not enrolling at this site — choose another above.

  • Site 2903
    Seoul, 03080, South Korea
    Completed

    Not enrolling at this site — choose another above.

  • Site 2904
    Seoul, 05505, South Korea
    Completed

    Not enrolling at this site — choose another above.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2020 (actual). Primary completion is estimated for Jun 2028, 92 months after the start.

Of 55 phase 1 interventional studies under Carcinoma, Ovarian Epithelial, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 81. This study's planned 92 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2020
First posted
Aug 18, 2020
StartActual
Oct 26, 2020
Primary completionEst.
Jun 30, 2028
CompletionEst.
Jun 30, 2028
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
11 sites added — first site in France. 3 sites changed recruiting status (2 now completed, 1 now active, not recruiting)
Show 3 sites
  • Site 0264 · Aurora, United StatesRecruiting→Active, not recruiting
  • Site 2706 · Melbourne, AustraliaRecruiting→Completed
  • Site 2705 · Nedlands, AustraliaRecruiting→Completed
Show 11 added (10 France, 1 Australia)
  • Site 2718 · Sunshine Coast, Australia
  • 3613 · Besançon, France
  • 3624 · Bordeaux, France
  • 3601 · Dijon, France
  • 3608 · Lyon, France
  • 3614 · Nantes, France
  • 3623 · Paris, France
  • 3604 · Paris, France
  • 3625 · Rennes, France
  • 3611 · Strasbourg, France
  • 3603 · Toulouse, France
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    11 sites added — first site in France. 3 sites changed recruiting status (2 now completed, 1 now active, not recruiting)
    Show 3 sites
    • Site 0264 · Aurora, United StatesRecruiting→Active, not recruiting
    • Site 2706 · Melbourne, AustraliaRecruiting→Completed
    • Site 2705 · Nedlands, AustraliaRecruiting→Completed
    Show 11 added (10 France, 1 Australia)
    • Site 2718 · Sunshine Coast, Australia
    • 3613 · Besançon, France
    • 3624 · Bordeaux, France
    • 3601 · Dijon, France
    • 3608 · Lyon, France
    • 3614 · Nantes, France
    • 3623 · Paris, France
    • 3604 · Paris, France
    • 3625 · Rennes, France
    • 3611 · Strasbourg, France
    • 3603 · Toulouse, France
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04516447
Lead sponsor
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Responsible party
Sponsor
First posted
Aug 18, 2020
Start date
Oct 26, 2020
Primary completion
Jun 30, 2028 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Nov 9, 2026

Study contacts

K-Group, Beta, Inc., a subsidiary of Zentalis Pharmaceuticals
Contact
medicalaffairs@zentalis.com
8582634333

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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