Recruiting
Phase 1

ZN-c3

Sponsor:

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

Code:

NCT04516447

Conditions

Solid Tumor

Epithelial Ovarian Cancer

Fallopian Tube Cancer

Peritoneal Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Azenosertib

Carboplatin

Pegylated liposomal doxorubicin

Paclitaxel

Gemcitabine

Study Details

Brief 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.

Conditions

Solid Tumor

Epithelial Ovarian Cancer

Fallopian Tube Cancer

Peritoneal Cancer

Study ID

NCT04516447

Start date

Oct 26, 2020

Status verified date

Apr, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

INCLUSION CRITERIA:

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:

• 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:

  • 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

Study Design

Enrollment

172 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: Azenosertib + carboplatin

Azenosertib in combination with carboplatin

experimental: Part 1: Azenosertib + PLD

Azenosertib in combination with pegylated liposomal doxorubicin (PLD)

experimental: Part 1: Azenosertib + paclitaxel

Azenosertib in combination with paclitaxel

experimental: Part 1: Azenosertib + gemcitabine

Azenosertib in combination with gemcitabine

experimental: Part 2: Azenosertib + bevacizumab

Azenosertib in combination with bevacizumab

Interventions

Azenosertib

Investigational drug

Carboplatin

Carboplatin is an approved drug

Pegylated liposomal doxorubicin

Pegylated liposomal doxorubicin (PLD) is an approved drug

Paclitaxel

Paclitaxel is an approved drug

Gemcitabine

Gemcitabine is an approved drug

Bevacizumab

Bevacizumab is an approved drug

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 ]
  • 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) ]
  • Part 2: To estimate the safety/tolerability of azenosertib in combination with bevacizumab [ Time Frame: Through study completion, an average of 1 year ]
  • Part 2: To identify the recommended dose for Part 2 Dose Expansion [ Time Frame: Through Cycle 1 (21 days) ]

Central Contacts and Locations

Central contacts

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

8582634333medicalaffairs@zentalis.com

Locations

Site 0264

Recruiting

Aurora, Colorado, United States, 80045

Site 0104

Recruiting

Boston, Massachusetts, United States, 02215

Site 0111

Recruiting

St Louis, Missouri, United States, 53110

Site 0173

Recruiting

New York, New York, United States, 10029

Site 0259

Recruiting

Durham, North Carolina, United States, 27710

Site 0191

Recruiting

Providence, Rhode Island, United States, 02905

Site 0103

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

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

Last update posted

Apr 7, 2026

Last verified

Apr, 2026

Keywords

  • Solid Tumor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc on 2026-04-07.