Phase 1a/b Study of ZL-6201 Safety, PK, and Preliminary Efficacy in Sarcoma and Selected Tumors

July 21, 2026 updated by: Zai Lab (Shanghai) Co., Ltd.

An Open-label, Phase 1a/b, Multicenter Study of ZL-6201 to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy in Participants With Sarcoma and Selected Solid Tumors

The purpose of this study is to evaluate the safety and tolerability of investigational study drug ZL-6201 for treating sarcoma and solid tumors cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

An Open-label, Phase 1a/b, Multicenter Study of ZL-6201 to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy in Participants with Sarcoma and Selected Solid Tumors

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100021
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200000
        • Recruiting
        • Shanghai East Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90007
        • Recruiting
        • Zai Lab Site 02003
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Zai Lab Site 02030
    • Florida
      • Sarasota, Florida, United States, 34232
        • Recruiting
        • Zai Lab Site 02026
        • Contact:
          • Site 02026
    • Missouri
      • St Louis, Missouri, United States, 63160
        • Recruiting
        • Zai Lab Site 02005
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Zai Lab Site 02002
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Zai Lab Site 02006
        • Contact:
          • Site 02006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 unresectable and/or metastatic sarcoma or a selected solid tumor
  • Participants must be willing to undergo a tumor biopsy prior to start of treatment or provide archived tumor tissue sample
  • Participants with sarcoma should have received no more than 2 lines of previous systemic therapies in the metastatic setting
  • Participants with selected epithelial solid tumors should have received no more than 3 lines of previous systemic therapy in the metastatic/relapsed refractory setting
  • Participants must have at least one measurable target lesion as defined by RECIST v1.1
  • Adequate organ and marrow function as listed per protocol
  • Must be negative for HIV, HBV, and HCV

Exclusion Criteria:

  • Participants with another known malignancy that has required treatment within the last 2 years
  • Symptomatic central nervous system (CNS) metastasis, and/or those requiring therapy with corticosteroids or anticonvulsants to control associated symptoms
  • Participants with leptomeningeal metastasis
  • Most recent systemic anti-cancer treatment or investigational products/devices less than 3 weeks
  • Prior treatment with a topoisomerase-1 inhibitor antibody drug conjugate
  • Impaired cardiac function or clinically significant cardiac disease within the last 3 months before administration of the first dose of the study treatment
  • Clinically significant pulmonary disease including autoimmune, connective tissue, or inflammatory conditions
  • Pregnant or nursing (lactating) women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ZL-6201
ZL-6201 as a single agent
Drug: ZL-6201
ZL-6201 as a single-agent

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Treatment Emergent Adverse Events
Time Frame: 36 months
Number of subjects with treatment-emergent adverse effects through dose escalation and expansion.
36 months
Incidence of Serious adverse events
Time Frame: 36 months
Number of subjects with Serious Adverse Events through dose escalation and expansion.
36 months
Number of participants with clinical laboratory abnormalities
Time Frame: 36 months
36 months
Number of participants with vital sign abnormalities
Time Frame: 36 months
Vitals will be measured in Riva Rocci (RR) in mmHG and Pulse in beats per minute
36 months
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame: 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.
36 months
Incidence of Dose Limiting Toxicities
Time Frame: 1 cycle of study treatment (each cycle is 21 days)
Number of subjects with dose limiting toxicities (DLTs) through dose escalation only.
1 cycle of study treatment (each cycle is 21 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ORR per RECIST 1.1
Time Frame: 36 months
Objective Response Rate (ORR) is defined as the proportion of participants who have a best response of confirmed partial response (PR) or confirmed complete response (CR) to study treatment per RECIST v1.1 by investigator assessment through dose escalation and expansion.
36 months
Duration of Response per RECIST 1.1
Time Frame: 36 months
Duration of Response is defined as the time from the first assessment of CR or PR to the first assessment of progression disease (PD) by investigator per RECIST 1.1 or death due to any cause (whichever occurs first) through dose escalation and expansion.
36 months
PFS per RECIST 1.1
Time Frame: 36 months
Progression-Free Survival (PFS) is defined as the time from first dosing date to the first documented PD by investigator per RECIST 1.1 or death for any reasons (whichever occurs first) through dose escalation and expansion.
36 months
DCR per RECIST 1.1
Time Frame: 36 months
Disease Control Rate (DCR) is defined as the proportion of participants who have a best response of confirmed CR, confirmed PR, or SD per RECIST 1.1 by investigator assessment through dose escalation and expansion.
36 months
PK characteristics of ZL-6201 (ADC conjugate), total antibody
Time Frame: 36 months
Pharmacokinetics: Total Antibody of ZL-6201
36 months
PK characteristics of ZL-6201 (ADC conjugate), unconjugated payloads
Time Frame: 36 month
Pharmacokinetics: Unconjugated payloads of ZL-6201
36 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zai Lab (Shanghai) Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zai Lab (US) LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 2, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZL-6201-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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