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ZL-1211

Phase 1

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

Success Probability

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Market & Valuation

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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 TumorUnlock 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
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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 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
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumor")

Frequently asked questions about ZL-1211

What is ZL-1211 used for?

ZL-1211 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and has been studied in patients with advanced solid tumors. The drug is not yet approved and remains under investigation.

Who makes ZL-1211?

ZL-1211 is being developed by Zai Lab Limited, a biopharmaceutical company traded on the NASDAQ under the ticker ZLAB. The company is conducting clinical research on this investigational oncology drug for advanced solid tumors.

What phase is ZL-1211 in?

ZL-1211 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 study has been completed, and the drug remains in early-stage clinical investigation for advanced solid tumors.

What clinical trials is ZL-1211 in?

ZL-1211 has been studied in a Phase 1 clinical trial with the identifier NCT05065710, titled "A Study of ZL-1211 in Patients With Advanced Solid Tumor." This single-arm, uncontrolled study enrolled 34 patients with advanced solid tumors and was conducted in the United States and China.

Is ZL-1211 the same as any other drug?

ZL-1211 is the primary name for this investigational drug. No alternative names have been established for this compound in the available clinical trial information. It is identified solely as ZL-1211 in the registered study.