Solid TumorPhase 1MUIRNCT04516447
A Study of Azenosertib (ZN-c3) in Patients With Ovarian Cancer
A Phase 1 study testing Azenosertib, Carboplatin and Pegylated liposomal doxorubicin in people with Solid Tumor and Epithelial Ovarian Cancer, run by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc at 24 sites in 7 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Solid Tumor, Epithelial Ovarian Cancer, Fallopian Tube Cancer
- What is being tested?
- Azenosertib, Carboplatin and Pegylated liposomal doxorubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 24 sitesin 7 countries
- Study dates
- 26 Oct 2020to 30 Jun 2028
- 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
- For Part 1:
- Histologically 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/lines of therapy in the advanced or metastatic 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 refractory disease (ie, PD during first-line platinum-based therapy) is allowed.
- For Part 2 Dose Escalation:
- Prior therapy:
Show all 16Show fewer
- 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:
- In the 1L setting: Complete Response, Partial Response, or Stable Disease to platinum-based chemotherapy.
- In the 2L setting:
- Progressive Disease >183 days after receiving the last dose of platinum chemotherapy in the 1L setting,
- 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
Who cannot join
- 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, metastatic) second malignancies or requiring therapy.
- Additional protocol-defined exclusion criteria may apply
Trial locations and contacts
24 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
K-Group, Beta, Inc., a subsidiary of Zentalis Pharmaceuticals contact
24 sites in 7 countries
United States8 sites, 7 recruiting
- Recruiting
Site 0264
Aurora, Colorado, 80045
- Recruiting
Site 0104
Boston, Massachusetts, 02215
- Recruiting
Site 0259
Durham, North Carolina, 27710
- Recruiting
Site 0103
Houston, Texas, 77030
- Completed
Site 0196
Nashville, Tennessee, 37203
- Recruiting
Site 0173
New York, New York, 10029
- Recruiting
Site 0191
Providence, Rhode Island, 02905
- Recruiting
Site 0111
St Louis, Missouri, 53110
Australia6 sites, 3 recruiting
- Completed
Site 2709
Adelaide, South Australia, 5000
- Recruiting
Site 2716
Melbourne, Victoria, 3121
- Recruiting
Site 2706
Melbourne, Victoria, 3144
- Recruiting
Site 2705
Nedlands, Western Australia, 6009
- Completed
Site 2707
South Brisbane, Queensland, 4101
- Completed
Site 2708
Sunshine Coast, Queensland, 4556
Bosnia and Herzegovina3 sites
- Completed
Site 1001
Banja Luka, 78000
- Completed
Site 1002
Sarajevo, 71000
- Completed
Site 1003
Tuzla, 75000
South Korea3 sites
- Completed
Site 2901
Busan
- Completed
Site 2903
Seoul, 03080
- Completed
Site 2904
Seoul, 05505
Bulgaria2 sites
- Completed
Site 1202
Panagyurishte, 4500
- Completed
Site 1201
Sofia, 1632
About this study
Official title: A Phase 1b Study of ZN-c3 in Combination With Chemotherapy or Bevacizumab in Subjects With Ovarian, Peritoneal, or Fallopian Tube Cancer
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.
- Being tested
- Azenosertib, Carboplatin, Pegylated liposomal doxorubicin, Paclitaxel, Gemcitabine
- Keywords
- Solid Tumor
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzenosertibDrug
Also called ZN-c3
Investigational drug
CarboplatinDrug
Carboplatin is an approved drug
Pegylated liposomal doxorubicinDrug
Pegylated liposomal doxorubicin (PLD) is an approved drug
PaclitaxelDrug
Paclitaxel is an approved drug
GemcitabineDrug
Gemcitabine is an approved drug
BevacizumabBiological
Bevacizumab is an approved drug
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Azenosertib + carboplatin | Experimental | Azenosertib in combination with carboplatin Receives: Drug: Azenosertib; Drug: Carboplatin |
| Part 1: Azenosertib + PLD | Experimental | Azenosertib in combination with pegylated liposomal doxorubicin (PLD) Receives: Drug: Azenosertib; Drug: Pegylated liposomal doxorubicin |
| Part 1: Azenosertib + paclitaxel | Experimental | Azenosertib in combination with paclitaxel Receives: Drug: Azenosertib; Drug: Paclitaxel |
| Part 1: Azenosertib + gemcitabine | Experimental | Azenosertib in combination with gemcitabine Receives: Drug: Azenosertib; Drug: Gemcitabine |
| Part 2: Azenosertib + bevacizumab | Experimental | Azenosertib in combination with bevacizumab Receives: Drug: Azenosertib; Biological: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Through study completion, an average of 1 year
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)
Measured: Through Cycle 1 (cycle is 28 days for PLD or paclitaxel, and 21 days for carboplatin, or gemcitabine)
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
Measured: Through study completion, an average of 1 year
Part 2: To identify the recommended dose for Part 2 Dose Expansion
Measured: Through Cycle 1 (21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start26 Oct 2020
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- 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
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516447
- Sponsor's protocol ID
- ZN-c3-002
- Acronym
- MUIR
- Status last verified
- Apr 2026
- First submitted
- 11 Aug 2020
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of ZN-c3 in Combination With Chemotherapy or Bevacizumab in Subjects With Ovarian, Peritoneal, or Fallopian Tube Cancer
- ClinicalTrials.gov ID
- NCT04516447
- Acronym / sponsor ID
- MUIR / ZN-c3-002
- Keywords
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 18 Aug 2020 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1: Azenosertib + carboplatin | Experimental | Drug: Azenosertib, Drug: CarboplatinAzenosertib in combination with carboplatin |
| Part 1: Azenosertib + PLD | Experimental | Drug: Azenosertib, Drug: Pegylated liposomal doxorubicinAzenosertib in combination with pegylated liposomal doxorubicin (PLD) |
| Part 1: Azenosertib + paclitaxel | Experimental | Drug: Azenosertib, Drug: PaclitaxelAzenosertib in combination with paclitaxel |
| Part 1: Azenosertib + gemcitabine | Experimental | Drug: Azenosertib, Drug: GemcitabineAzenosertib in combination with gemcitabine |
| Part 2: Azenosertib + bevacizumab | Experimental | Drug: Azenosertib, Biological: BevacizumabAzenosertib in combination with bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically 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/lines of therapy in the advanced or metastatic 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 refractory disease (ie, PD during first-line platinum-based therapy) is allowed.
- Subjects must have received 6 cycles of platinum-based doublet chemotherapy in the 1L or 2L setting as their most recent therapy
- In the 1L setting: Complete Response, Partial Response, or Stable Disease to platinum-based chemotherapy.
Key exclusion criteria (5 listed)
- 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, metastatic) second malignancies or requiring therapy.
- Additional protocol-defined exclusion criteria may apply
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 |
|---|---|---|
| AzenosertibAlso: ZN-c3Investigational drug | Drug | Part 1: Azenosertib + PLD, Part 1: Azenosertib + carboplatin, Part 1: Azenosertib + gemcitabine, Part 1: Azenosertib + paclitaxel, Part 2: Azenosertib + bevacizumab |
| CarboplatinCarboplatin is an approved drug | Drug | Part 1: Azenosertib + carboplatin |
| Pegylated liposomal doxorubicinPegylated liposomal doxorubicin (PLD) is an approved drug | Drug | Part 1: Azenosertib + PLD |
| PaclitaxelPaclitaxel is an approved drug | Drug | Part 1: Azenosertib + paclitaxel |
| GemcitabineGemcitabine is an approved drug | Drug | Part 1: Azenosertib + gemcitabine |
| BevacizumabBevacizumab is an approved drug | Biological | Part 2: Azenosertib + bevacizumab |
Primary outcome
Part 1: To investigate the safety and tolerability of azenosertib in combination with PLD, carboplatin, paclitaxel, or gemcitabine
Time frame: Through study completion, an average of 1 year
Incidence and severity of adverse events (AEs)
Part 1: To identify the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of azenosertib in combination with PLD, carboplatin, paclitaxel, or gemcitabine
Time frame: Through Cycle 1 (cycle is 28 days for PLD or paclitaxel, and 21 days for carboplatin, or gemcitabine)
Incidence and severity of dose-limiting toxicities (DLTs)
Part 2: To estimate the safety/tolerability of azenosertib in combination with bevacizumab
Time frame: Through study completion, an average of 1 year
Incidence and severity of adverse events (AEs) Incidence of dose interruptions, reductions, and discontinuations due to treatment-related AEs
Part 2: To identify the recommended dose for Part 2 Dose Expansion
Time frame: Through Cycle 1 (21 days)
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 7 Apr 2026.
- Individual participant dataSharing planned: No
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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.
K-Group, Beta, Inc., a subsidiary of Zentalis Pharmaceuticals contact
24 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Azenosertib, Carboplatin and Pegylated liposomal doxorubicin in people with Solid Tumor and Epithelial Ovarian Cancer, run by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc at 24 sites in 7 countries.
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 16 inclusion and 5 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 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Australia, Bosnia and Herzegovina, South Korea, Bulgaria and 2 more countries. 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 K-Group, Beta, Inc., a subsidiary of Zentalis Pharmaceuticals (8582634333, medicalaffairs@zentalis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: To investigate the safety and tolerability of azenosertib in combination with PLD, carboplatin, paclitaxel, or gemcitabine (time frame: Through study completion, an average of 1 year). The study lists 4 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 7 Apr 2026.