Solid TumorsPhase 1NCT07374848
Phase 1a/b Study of ZL-6201 Safety, PK, and Preliminary Efficacy in Sarcoma and Selected Tumors
A Phase 1 study testing ZL-6201 in people with Solid Tumors and Sarcomas, run by Zai Lab (Shanghai) Co., Ltd. at 8 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Sarcomas
- What is being tested?
- ZL-6201
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 2 Mar 2026to Sep 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
United States6 sites, 6 recruiting
- Recruiting
Zai Lab Site 02006
Fairfax, Virginia, 22031
Site 02006
- Recruiting
Zai Lab Site 02003
Los Angeles, California, 90007
- Recruiting
Zai Lab Site 02030
New Haven, Connecticut, 06510
- Recruiting
Zai Lab Site 02002
New York, New York, 10065
- Recruiting
Zai Lab Site 02026
Sarasota, Florida, 34232
Site 02026
- Recruiting
Zai Lab Site 02005
St Louis, Missouri, 63160
China2 sites, 2 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200000
About this study
Official title: 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.
Read the 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
- Conditions
- Solid Tumors, Sarcomas
- Being tested
- ZL-6201
- Keywords
- Sarcoma, Solid Tumors, Phase1, Antibody-Drug Conjugate (ADC), Leucine-Rich Repeat-Containing protein 15 (LRRC15)
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZL-6201Drug
ZL-6201 as a single-agent
| Study group | Role | What they receive |
|---|---|---|
| ZL-6201 | Experimental | ZL-6201 as a single agent Receives: Drug: ZL-6201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities
Number of subjects with dose limiting toxicities (DLTs) through dose escalation only.
Measured: 1 cycle of study treatment (each cycle is 21 days)
Incidence of Treatment Emergent Adverse Events
Number of subjects with treatment-emergent adverse effects through dose escalation and expansion.
Measured: 36 months
Incidence of Serious adverse events
Number of subjects with Serious Adverse Events through dose escalation and expansion.
Measured: 36 months
Number of participants with clinical laboratory abnormalities
Measured: 36 months
Number of participants with vital sign abnormalities
Vitals will be measured in Riva Rocci (RR) in mmHG and Pulse in beats per minute
Measured: 36 months
Number of participants with electrocardiogram (ECG) abnormalities
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.
Measured: 36 months
Secondary outcomes (6)
ORR per RECIST 1.1
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.
Measured: 36 months
Duration of Response per RECIST 1.1
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.
Measured: 36 months
PFS per RECIST 1.1
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.
Measured: 36 months
DCR per RECIST 1.1
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.
Measured: 36 months
PK characteristics of ZL-6201 (ADC conjugate), total antibody
Pharmacokinetics: Total Antibody of ZL-6201
Measured: 36 months
PK characteristics of ZL-6201 (ADC conjugate), unconjugated payloads
Pharmacokinetics: Unconjugated payloads of ZL-6201
Measured: 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start2 Mar 2026
- Primary completionAug 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zai Lab (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zai Lab (US) LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374848
- Sponsor's protocol ID
- ZL-6201-001
- Status last verified
- Feb 2026
- First submitted
- 15 Dec 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07374848
- Acronym / sponsor ID
- ZL-6201-001
- Conditions
- Solid Tumors, Sarcomas
- Keywords
- Sarcoma, Solid Tumors, Phase1, Antibody-Drug Conjugate (ADC), Leucine-Rich Repeat-Containing protein 15 (LRRC15)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Zai Lab (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Zai Lab (US) LLC
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZL-6201 | Experimental | Drug: ZL-6201ZL-6201 as a single agent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZL-6201ZL-6201 as a single-agent | Drug | ZL-6201 |
Primary outcome
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.
Incidence of Treatment Emergent Adverse Events
Time frame: 36 months
Number of subjects with treatment-emergent adverse effects through dose escalation and expansion.
Incidence of Serious adverse events
Time frame: 36 months
Number of subjects with Serious Adverse Events through dose escalation and expansion.
Number of participants with clinical laboratory abnormalities
Time frame: 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
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.
6 secondary outcomes
ORR per RECIST 1.1
Time frame: 36 months
Duration of Response per RECIST 1.1
Time frame: 36 months
PFS per RECIST 1.1
Time frame: 36 months
DCR per RECIST 1.1
Time frame: 36 months
PK characteristics of ZL-6201 (ADC conjugate), total antibody
Time frame: 36 months
PK characteristics of ZL-6201 (ADC conjugate), unconjugated payloads
Time frame: 36 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZL-6201 in people with Solid Tumors and Sarcomas, run by Zai Lab (Shanghai) Co., Ltd. at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ZL-6201-001 Study Team (650.360.1601, ZL-6201-001@zailaboratory.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose Limiting Toxicities (time frame: 1 cycle of study treatment (each cycle is 21 days)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.