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 24 sites in 7 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc · Phase 1, Interventional, and Treatment
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.
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
For Part 1:
For Part 2 Dose Escalation:
Prior therapy:
Response to prior platinum therapy:
In the 2L setting:
Complete Response, Partial Response, or Stable Disease to 2L platinum-based chemotherapy.
For Part 2 Dose Expansion:
EXCLUSION CRITERIA:
Additional protocol-defined exclusion criteria may apply
Azenosertib in combination with carboplatin
Drug: Azenosertib · Drug: Carboplatin
Azenosertib in combination with pegylated liposomal doxorubicin (PLD)
Drug: Azenosertib · Drug: Pegylated liposomal doxorubicin
Azenosertib in combination with paclitaxel
Drug: Azenosertib · Drug: Paclitaxel
Azenosertib in combination with gemcitabine
Drug: Azenosertib · Drug: Gemcitabine
Azenosertib in combination with bevacizumab
Drug: Azenosertib · Biological: Bevacizumab
Investigational drug
Also known as: ZN-c3
Carboplatin is an approved drug
Pegylated liposomal doxorubicin (PLD) is an approved drug
Paclitaxel is an approved drug
Gemcitabine is an approved drug
Bevacizumab is an approved drug
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
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)
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
Part 2: To identify the recommended dose for Part 2 Dose Expansion
Time frame: Through Cycle 1 (21 days)
Plan to share: No
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Carcinoma, Ovarian Epithelial→
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc