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Recruiting Phase 1

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

NCT07374848 · tracked via the Priya Life Science China tracker
Phase
Phase 1
Started
2026-03-02
Last updated
2026-07-23

Condition(s) studied

Solid TumorsSarcomas

Investigational drug(s) / intervention(s)

ZL-6201

ZL-6201: ZL-6201 as a single-agent

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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.

Trial sites (8)

FacilityCityRegionStatus
Zai Lab Site 02003 Los Angeles California Recruiting
Zai Lab Site 02030 New Haven Connecticut Recruiting
Zai Lab Site 02026 Sarasota Florida Recruiting
Zai Lab Site 02005 St Louis Missouri Recruiting
Zai Lab Site 02002 New York New York Recruiting
Zai Lab Site 02006 Fairfax Virginia Recruiting
Cancer Hospital Chinese Academy of Medical Sciences Beijing Beijing Municipality Recruiting
Shanghai East Hospital Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07374848 on ClinicalTrials.gov ↗ ← All trials in China