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ZL-2306

Phase 1

Ovarian Cancer | Small molecule | Oncology |Zai Lab Limited|Last Updated: Jan 24, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment42
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03551171The Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of ZL-2306 (Niraparib) in Patients With Ovarian CancerPHASE1 COMPLETED 42 — — Dec 19, 2017Jul 10, 2018Jan 24, 20196 China
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Study Endpoints
Primary Endpoints
Maximum plasma drug concentration (Cmax)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Time to reach Cmax (Tmax)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Terminal rate constant (λz)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Elimination half-life (t1/2)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Area under the plasma concentration-time curve from time zero to 24hrs (AUC (0-24))
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUC(0-t)) and from zero to infinity (AUC0-∞)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Apparent total body clearance of the drug from plasma (CL/F)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Apparent volume of distribution (Vd/f)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Mean residence time (MRT)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Degree of fluctuation (DF)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Maximum plasma drug concentration at steady-state (Css max)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Time to reach Css max (Tss max)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Minimum plasma drug concentration at steady-state (Css min)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Area under the plasma concentration-time curve from time zero to the end of drug administration (AUCss)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Steady-state apparent total body clearance of drug from plasma (Clss/F)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Accumulation ratio following multiple drug administration (RAC)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
The plasma drug concentration before drug administration
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Secondary Endpoints
Number of participants with adverse events as assessed by CTCAE v4.0
From the signing of ICF till the end of this study (30 days after the last administration of the study drug or the date to close the clinical trial database, whichever is earlier)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ZL-2306 (niraparib)EXPERIMENTALSubjects will be randomised into 100mg, 200mg, 300mg dose group at the first day of the first cycle.
Interventions
NameTypeDescription
ZL-2306 (niraparib)DRUGAbout 30 subjects will be enrolled to the study, and randomised into 300mg, 200mg and 100mg dose groups (about 10 subjects per group). All subjects will be randomised into indicated dose group (300mg, 200mg or 100mg) at the first day of the first cycle. A single administration of ZL-2306 (niraparib) will be given to the subjects at indicated dose.
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: 1. Signed informed consent . 2. Female, age ≥ 18 years. 3. Histologically confirmed diagnosis of FIGO stage III or IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. 4. Has received no further than second-line platinum-based chemotherapy, and has clinical co...

Countries:China
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Competitive Landscape -Ovarian Cancer 180 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK5PHASE3Pembrolizumab, Paclitaxel, Bevacizumab, Docetaxel, Sacituzumab tirumotecan
AstraZeneca PLCAZN19PHASE3Olaparib, Bevacizumab, Durvalumab, Carboplatin+Paclitaxel, AZD5335
Eli Lilly and CompanyLLY8PHASE3Sofetabart Mipitecan, Paclitaxel, Topotecan, Gemcitabine, Pegylated liposomal doxorubicin
AbbVie, Inc.ABBV13PHASE3Mirvetuximab soravtansine plus Bevacizumab, Bevacizumab, Mirvetuximab soravtansine, Carboplatin, Mirvetuximab Soravtansine
GSK plc Sponsored ADRGSK4PHASE3Niraparib, Dostarlimab, Mocertatug rezetecan, Paclitaxel, Pegylated liposomal doxorubicin
Bristol-Myers Squibb CompanyBMY4PHASE3Rucaparib, Nivolumab, BMS-986340, BMS-936558-01, Docetaxel
Pfizer Inc.PFE5PHASE3Avelumab, Lorlatanib, Talazoparib, Pemetrexed, Axitinib
Genmab A/S Sponsored ADRGMAB5PHASE3Rina-S, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin, Gemcitabine
Corcept Therapeutics Incorporated.CORT2PHASE3Nab-paclitaxel /m^2, Relacorilant once daily, Bevacizumab /kg
Verastem, Inc.VSTM4PHASE3avutometinib, Defactinib, Pegylated liposomal doxorubicin, Paclitaxel, Letrozole
Imunon, Inc.IMNN3PHASE3IMNN-001, Paclitaxel, Carboplatin, Olaparib, Niraparib
Zentalis Pharmaceuticals, Inc.ZNTL3PHASE3Azenosertib, azenosertib, Carboplatin, Pegylated liposomal doxorubicin, Paclitaxel
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, KFA115, pembrolizumab, Tulmimetostat
BeOne Medicines Ltd. Sponsored ADRONC2PHASE3Pamiparib, BG-68501, Fulvestrant, BGB-43395
IQVIA Holdings IncIQV1PHASE3Oregovomab, Paclitaxel, Carboplatin
Exelixis, Inc.EXEL2PHASE2Cabozantinib, cabozantinib, atezolizumab
Xencor, Inc.XNCR3PHASE2vudalimab, XmAb541, XmAb808
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