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ZL-1201

Phase 1

Advanced Cancer | Small molecule | Oncology |Zai Lab Limited|Last Updated: Aug 22, 2023

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 Enrollment37
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04257617A Trial of ZL-1201 in Subjects With Advanced CancerPHASE1 COMPLETED 37May 11, 2020Jan 19, 2023Aug 22, 20237 United States, China
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Study Endpoints
Primary Endpoints
Safety and tolerability of ZL-1201 when administered as an intravenous (IV) infusion: Incidence of Treatment-Emergent Adverse Events
From the time of informed consent to 30 days after last dose

Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0

Secondary Endpoints
Pharmacokinetics:AUC
Up to 30 days after last dose
Pharmacokinetics: Cmax
Up to 30 days after last dose
Pharmacokinetics: t1/2
Up to 30 days after last dose
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Single arm, ZL-1201EXPERIMENTALSingle arm, ZL-1201
Interventions
NameTypeDescription
ZL-1201DRUGPart 1 \& 2: Escalating dose of ZL-1201, Part 3: three dose levels determined from Part 1 and Part 2.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumors and lymphomas that are refractory or intolerant to standard of care therapy, or for which no standard therapy exists. * Adequate hematologic status * Adequate coagulation function ...

Countries:United StatesChina
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