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ZL-1201

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

Clinical trial landscape

ZL-1201 · 1 trial · 1 indication

Phase 1 1
NCT04257617A Trial of ZL-1201 in Subjects With Advanced CancerAdvanced Cancer
COMPLETED37 Analytics
PHASE1COMPLETED
A Trial of ZL-1201 in Subjects With Advanced Cancer
Advanced CancerUnlock trial analytics

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 to 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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Competitive Landscape -Cancer 5 trials (matched to "Advanced Cancer")

Frequently asked questions about ZL-1201

What is ZL-1201 used for?

ZL-1201 is an investigational small molecule being developed for the treatment of advanced cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with advanced cancer to evaluate its safety and potential efficacy.

Who makes ZL-1201?

ZL-1201 is being developed by Zai Lab Limited, a biopharmaceutical company traded on the NASDAQ under the ticker symbol ZLAB. The company is conducting clinical trials for this investigational oncology drug.

What phase is ZL-1201 in?

ZL-1201 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The Phase 1 trial has been completed, and the drug remains in early-stage clinical development for advanced cancer.

What clinical trials is ZL-1201 in?

ZL-1201 has one completed clinical trial, identified as NCT04257617, titled "A Trial of ZL-1201 in Subjects With Advanced Cancer." This Phase 1 study enrolled 37 participants with advanced cancer and was conducted in the United States and China.

Is ZL-1201 the same as any other drug?

ZL-1201 is the primary name for this investigational drug. No alternative names have been reported for this compound. It is a small molecule being studied for its potential use in oncology.