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ZL-1201

Phase 1

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

ZL-1201 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 2020

ZL-1201 target and mechanism

Molecular targetCD47
Target classProtein
ModalitySmall molecule

Also known as Monotherapy

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

ZL-1201 clinical trials

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 7 trials (matched to "Advanced Cancer")

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Frequently asked questions about ZL-1201

What is ZL-1201?

ZL-1201 is an investigational small molecule developed by Zai Lab Limited for the treatment of advanced cancer. It is a CD47-targeted therapy that has been studied in a Phase 1 clinical trial. ZL-1201 is not approved and remains in clinical development.

What does ZL-1201 target?

ZL-1201 targets CD47, a protein that cancer cells use to evade immune detection. By binding CD47, ZL-1201 is designed to enable immune cells such as macrophages to recognize and attack tumor cells. CD47 is a protein target, and ZL-1201 is a small molecule therapeutic.

Who makes ZL-1201?

ZL-1201 is developed by Zai Lab Limited, a biopharmaceutical company traded on the Nasdaq under the ticker ZLAB. Zai Lab is advancing ZL-1201 as part of its oncology pipeline for patients with advanced cancer.

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 any other regulatory agency. The Phase 1 program has been conducted in patients with advanced cancer.

What clinical trials is ZL-1201 in?

ZL-1201 has been evaluated in one Phase 1 clinical trial, NCT04257617, titled A Trial of ZL-1201 in Subjects With Advanced Cancer. The trial enrolled 37 participants across the United States and China, was uncontrolled, and has been completed.