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
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:
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- 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