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Investigator's choice of Chemotherapy

Phase 3

Ovarian Cancer | Small molecule | Oncology |Zentalis Pharmaceuticals, Inc.|Last Updated: Aug 12, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment420

FDA Designations

No designations recorded

Clinical trial landscape

Investigator's choice of Chemotherapy · 1 trial · 1 indication

Phase 3 1
NCT07546500A Study of Azenosertib (ZN-c3) Versus Investigator's Choice Chemotherapy in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein ExpressionOvarian Cancer
RECRUITING420 Analytics
PHASE3RECRUITING
A Study of Azenosertib (ZN-c3) Versus Investigator's Choice Chemotherapy in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression
Ovarian CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression free survival (PFS) per RECIST v1.1 as assessed by Investigator
Up to approximately 24 months from the enrollment of the last subject

Time from randomization to the first documented tumor progression (per RECIST v1.1) or death from any cause, whichever occurs first.

Secondary Endpoints

Overall survival
Up to approximately 24 months from the enrollment of the last subject
PFS per RECIST 1.1 as assessed by blinded independent central review (ICR)
Up to approximately 24 months from the enrollment of the last subject
Objective Response Rate (ORR) per RECIST v1.1 and assessed by Investigator
Up to approximately 24 months from the enrollment of the last subject
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm A Azenosertib 400 mg administered daily on a 5 days on, 2 days off intermittent scheduleEXPERIMENTAL -
Experimental: Arm C Investigator's choice of chemotherapy at the dose defined by the protocolACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Investigator's choice of ChemotherapyDRUGThe investigator will select the chemotherapy in accordance with the protocol defined requirements. The possible choices as defined by the protocol: * Paclitaxel * Gemcitabine * Pegylated liposomal doxorubicin (PLD) * Topotecan The selected chemotherapy will be administered intravenously
AzenosertibDRUGAzenosertib 400 mg will be administered orally.
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites59

Inclusion Criteria: 1. Female age ≥ 18 years 2. High-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer 3. Measurable disease per RECIST Version 1.1 4. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1 5. The subject's tumor tissue must be positive fo...

Countries:United StatesAustraliaBelgiumCanadaFranceGermanyIrelandItalyPolandSouth KoreaSpainTaiwan
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Competitive Landscape -Ovarian Cancer 176 trials

Top 20 of 59 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK5PHASE3Pembrolizumab, Paclitaxel, Bevacizumab, Docetaxel
AstraZeneca PLCAZN19PHASE3Olaparib
GSK plc Sponsored ADRGSK4PHASE3Niraparib
Eli Lilly and CompanyLLY8PHASE3Sofetabart Mipitecan, Paclitaxel, Topotecan, Gemcitabine, Pegylated liposomal doxorubicin
AbbVie, Inc.ABBV13PHASE3Mirvetuximab soravtansine plus Bevacizumab, Bevacizumab
Bristol-Myers Squibb CompanyBMY4PHASE3Rucaparib, Nivolumab
Genmab A/S Sponsored ADRGMAB5PHASE3Rina-S, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin, Gemcitabine
Pfizer Inc.PFE4PHASE3Avelumab, Lorlatanib, Talazoparib, Pemetrexed, Axitinib
Corcept Therapeutics Incorporated.CORT2PHASE3Nab-paclitaxel/m^2, Relacorilant once daily
Verastem, Inc.VSTM4PHASE3avutometinib, Defactinib, Pegylated liposomal doxorubicin, Paclitaxel, Letrozole
Zentalis Pharmaceuticals, Inc.ZNTL3PHASE3Azenosertib
Imunon, Inc.IMNN3PHASE3IMNN-001, Paclitaxel, Carboplatin, Olaparib, Niraparib
Incyte CorporationINCY2PHASE3INCB123667
Genelux Corp.GNLX1PHASE3olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin or cisplatin, Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane or pegylated liposomal doxorubicin, Bevacizumab
Regeneron Pharmaceuticals, Inc.REGN4PHASE2Ubamatamab, Bevacizumab, Cemiplimab, Fianlimab, PLD
Novartis AG Sponsored ADRNVS4PHASE2Dabrafenib, Trametinib
BeOne Medicines Ltd. Sponsored ADRONC2PHASE3Pamiparib
IQVIA Holdings IncIQV1PHASE3Oregovomab, Paclitaxel, Carboplatin
Xencor, Inc.XNCR3PHASE2vudalimab
Exelixis, Inc.EXEL2PHASE2Cabozantinib
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Recent Changes (Last 90 Days)

LOWAug 12, 2026NCT07546500lastUpdatePostDate: changed
LOWAug 12, 2026NCT07546500lastUpdatePostDate: changed
LOWJul 17, 2026NCT07546500lastUpdatePostDate: changed
LOWJul 17, 2026NCT07546500lastUpdatePostDate: changed
LOWJun 29, 2026NCT07546500lastUpdatePostDate: changed
LOWJun 29, 2026NCT07546500lastUpdatePostDate: changed

Frequently asked questions about Investigator's choice of Chemotherapy

What is Investigator's choice of Chemotherapy used for in ovarian cancer?

Investigator's choice of Chemotherapy is used as an active control in a Phase 3 study for patients with platinum-resistant high-grade serous ovarian, primary peritoneal, or fallopian tube cancers that are positive for cyclin E1 protein expression. It is being compared against the investigational drug azenosertib (ZN-c3) in this setting.

Who makes Investigator's choice of Chemotherapy?

Investigator's choice of Chemotherapy is not a single drug made by one company; it refers to a selection of standard chemotherapy regimens chosen by the study investigator. The clinical trial comparing it to azenosertib is sponsored by Zentalis Pharmaceuticals, Inc. (ticker: ZNTL).

What phase is Investigator's choice of Chemotherapy in?

Investigator's choice of Chemotherapy is not an investigational drug in development; it serves as the active control arm in a Phase 3 clinical trial. The trial, NCT07546500, is currently recruiting and compares this chemotherapy to the investigational agent azenosertib in ovarian cancer.

What clinical trials is Investigator's choice of Chemotherapy in?

Investigator's choice of Chemotherapy is part of one Phase 3 clinical trial, NCT07546500, which is recruiting 420 female patients aged 18 and older. The study is active in the United States, Australia, Belgium, Canada, France, Germany, Ireland, Italy, Poland, South Korea, Spain, and Taiwan.

Is Investigator's choice of Chemotherapy the same as azenosertib?

No, Investigator's choice of Chemotherapy is not the same as azenosertib. Azenosertib (ZN-c3) is the investigational drug being tested in the Phase 3 trial, while Investigator's choice of Chemotherapy is the standard-of-care control arm that azenosertib is being compared against in patients with platinum-resistant ovarian cancer.