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Phase 1a/b Study of ZL-6201 for Sarcoma and Solid Tumors

This study is testing a new drug called ZL-6201 to see how safe it is and how well your body handles it. It's for adults aged 18 and older who have locally advanced (cancer that has grown into nearby tissues) or metastatic (cancer that has spread to other parts of the body) sarcoma or certain other solid tumors. The main goals are to track any side effects and serious problems you might have. The study is currently unclear about its recruitment status, but plans to enroll up to 180 participants.

Study design
This is an open-label, Phase 1a/b study, meaning both you and your doctors will know you are receiving ZL-6201. It will involve multiple centers and plans to enroll up to 180 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will be monitored for side effects for up to 36 months after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07374848

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Zai Lab (Shanghai) Co., Ltd.
~180 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:ZL-6201

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Dose Limiting Toxicities
Measured over 1 cycle of study treatment (each cycle is 21 days)
+5 more outcomes measured

Conditions

Solid Tumors
Sarcomas

Explore related trials

SarcomaSolid NeoplasmLeucine-Rich Repeat-Containing Protein 15

Where it's being run

8 sites across 8 states
California1
Connecticut1
Florida1
Missouri1
New York1
Virginia1
Beijing Municipality1
Shanghai Municipality1

Who to contact

ZL-6201-001 Study Team
[email protected]
650.360.1601
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence of Dose Limiting Toxicities1 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 Events36 months

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

  • Incidence of Serious adverse events36 months

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

  • Number of participants with clinical laboratory abnormalities36 months
  • Number of participants with vital sign abnormalities36 months

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

  • Number of participants with electrocardiogram (ECG) abnormalities36 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.