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ZL-1211

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Zai Lab Limited|Last Updated: Sep 3, 2024

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 Enrollment34
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05065710A Study of ZL-1211 in Patients With Advanced Solid TumorPHASE1 COMPLETED 34Jan 19, 2022Apr 9, 2024Sep 3, 202421 United States, China
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Study Endpoints
Primary Endpoints
Phase I :MTD or MAD
One month

To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) (if no MTD is defined) of ZL-1211

Phase I and Phase II: safety and tolerability
Approximately 10 months

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

Phase II: preliminary antitumor activity
Approximately 10 months

Objective response rate defined as the proportion of patients with partial response (PR) proportion of patients with partial response (PR) or complete response (CR) based on Investigator assessment of tumor lesions per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Secondary Endpoints
Phase I and Phase II: pharmacokinetics (PK):AUC
Approximately 10 months
Phase I and Phase II: pharmacokinetics (PK):Cmax
Approximately 10 months
Phase I and Phase II: pharmacokinetics (PK):Tmax
Approximately 10 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ZL-1211 monotherapyEXPERIMENTAL -
Interventions
NameTypeDescription
ZL-1211DRUGPhase 1 dose escalation part will enroll about 12-42 patients, Phase 2 dose expansion part will enroll about 15-40 patients in each cohort
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: Patients are eligible to be included in the study only if all the following inclusion criteria apply: 1. Adults≥ 18 years of age. 2. Willing and able to provide signed and dated informed consent prior to any study related procedures and willing and able to comply with all study...

Countries:United StatesChina
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