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ZL-6201

Phase 1

Solid Tumors | Small molecule | Oncology |Zai Lab Limited|Last Updated: Jul 23, 2026

Target and mechanism

Molecular targetLRRC15
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment180

FDA Designations

No designations recorded

Clinical trial landscape

ZL-6201 · 1 trial · 2 indications

Phase 1 1
NCT07374848Phase 1a/b Study of ZL-6201 Safety, PK, and Preliminary Efficacy in Sarcoma and Selected TumorsSolid Tumors
RECRUITING180 Analytics
PHASE1RECRUITING
Phase 1a/b Study of ZL-6201 Safety, PK, and Preliminary Efficacy in Sarcoma and Selected Tumors
Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Dose Limiting Toxicities
1 cycle of study treatment (each cycle is 21 days)

Number of subjects with dose limiting toxicities (DLTs) through dose escalation only.

Incidence of Treatment Emergent Adverse Events
36 months

Number of subjects with treatment-emergent adverse effects through dose escalation and expansion.

Incidence of Serious adverse events
36 months

Number of subjects with Serious Adverse Events through dose escalation and expansion.

Number of participants with clinical laboratory abnormalities
36 months
Number of participants with vital sign abnormalities
36 months

Vitals will be measured in Riva Rocci (RR) in mmHG and Pulse in beats per minute

Number of participants with electrocardiogram (ECG) abnormalities
36 months

ECG will be measured in ECG intervals (QT and QTc with Fridericia correction, and PR), QRS duration, and heart rate will be tested and analyzed.

Secondary Endpoints

ORR per RECIST 1.1
36 months
Duration of Response per RECIST 1.1
36 months
PFS per RECIST 1.1
36 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ZL-6201EXPERIMENTALZL-6201 as a single agent

Interventions

NameTypeDescription
ZL-6201DRUGZL-6201 as a single-agent
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Adult men and women ≥18 years of age at the time of signing the ICF with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a life expectancy \> 3 months * Participants must have histologically confirmed and documented diagnosis of locally advanced u...

Countries:United StatesChina
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumors")

Recent Changes (Last 90 Days)

LOWJul 24, 2026NCT07374848lastUpdatePostDate: changed
LOWJul 24, 2026NCT07374848lastUpdatePostDate: changed
LOWJul 22, 2026NCT07374848lastUpdatePostDate: changed
LOWJul 22, 2026NCT07374848lastUpdatePostDate: changed
LOWJun 22, 2026NCT07374848lastUpdatePostDate: changed
LOWJun 22, 2026NCT07374848lastUpdatePostDate: changed
LOWMay 29, 2026NCT07374848startDate: changed
LOWMay 29, 2026NCT07374848startDate: changed
LOWMay 29, 2026NCT07374848startDate: changed

Frequently asked questions about ZL-6201

What is ZL-6201 used for?

ZL-6201 is an investigational small molecule being developed for the treatment of solid tumors, including sarcomas. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does ZL-6201 target?

ZL-6201 targets LRRC15, a protein involved in the tumor microenvironment. By binding to this target, the drug aims to modulate the tumor's surrounding cells, potentially inhibiting tumor growth and progression.

Who makes ZL-6201?

ZL-6201 is being developed by Zai Lab Limited, a biopharmaceutical company. The company is conducting clinical trials for this drug in the United States and China.

What phase is ZL-6201 in?

ZL-6201 is in Phase 1 clinical development. It is currently being studied in a Phase 1a/b trial that is recruiting participants, and it remains an investigational drug not yet approved for commercial use.

What clinical trials is ZL-6201 in?

ZL-6201 is being evaluated in a Phase 1a/b study (NCT07374848) that assesses its safety, pharmacokinetics, and preliminary efficacy in patients with solid tumors and sarcomas. The trial is recruiting up to 180 participants aged 18 years and older.