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ZL-6201

Phase 1

Solid Tumors | Small molecule | Oncology |Zai Lab Limited|Last Updated: May 28, 2026

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment180
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07374848Phase 1a/b Study of ZL-6201 Safety, PK, and Preliminary Efficacy in Sarcoma and Selected TumorsPHASE1 RECRUITING 180Mar 2, 2026Sep 1, 2029May 28, 20265 United States
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Study Endpoints
Primary Endpoints
Incidence of Dose Limiting Toxicities
1 cycle of study treatment (each cycle is 21 days)

Number of subjects with dose limiting toxicities (DLTs) through dose escalation only.

Incidence of Treatment Emergent Adverse Events
36 months

Number of subjects with treatment-emergent adverse effects through dose escalation and expansion.

Incidence of Serious adverse events
36 months

Number of subjects with Serious Adverse Events through dose escalation and expansion.

Number of participants with clinical laboratory abnormalities
36 months
Number of participants with vital sign abnormalities
36 months

Vitals will be measured in Riva Rocci (RR) in mmHG and Pulse in beats per minute

Number of participants with electrocardiogram (ECG) abnormalities
36 months

ECG will be measured in ECG intervals (QT and QTc with Fridericia correction, and PR), QRS duration, and heart rate will be tested and analyzed.

Secondary Endpoints
ORR per RECIST 1.1
36 months
Duration of Response per RECIST 1.1
36 months
PFS per RECIST 1.1
36 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ZL-6201EXPERIMENTALZL-6201 as a single agent
Interventions
NameTypeDescription
ZL-6201DRUGZL-6201 as a single-agent
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Adult men and women ≥18 years of age at the time of signing the ICF with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a life expectancy \> 3 months * Participants must have histologically confirmed and documented diagnosis of locally advanced u...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 29, 2026NCT07374848startDate: changed
LOWMay 29, 2026NCT07374848startDate: changed
LOWMay 29, 2026NCT07374848startDate: changed
LOWMay 26, 2026NCT07374848primaryCompletionDate: changed
LOWMay 24, 2026NCT07374848studyFirstPostDate: changed