Recent Updates
Recently added Catalysts

ZL-1211

Phase 1

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

Success Probability
Subscribe to view
Market & Valuation
Subscribe to view
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment34
FDA Designations
No designations recorded
Clinical trial landscape

ZL-1211 · 1 trial · 1 indication

Phase 1 1
NCT05065710A Study of ZL-1211 in Patients With Advanced Solid TumorAdvanced Solid Tumor
COMPLETED34 Analytics
PHASE1COMPLETED
A Study of ZL-1211 in Patients With Advanced Solid Tumor
Advanced Solid Tumor
NCT0506571034
Unlock trial analytics
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
Unlock Study Endpoints
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
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years to 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
Unlock Eligibility Criteria
Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumor")
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
Unlock Competitive Intelligence