Recruiting
Phase 1

ZL-6201

Sponsor:

Zai Lab (Shanghai) Co., Ltd.

Code:

NCT07374848

Conditions

Solid Tumors

Sarcomas

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ZL-6201

Study Details

Brief 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.

Conditions

Solid Tumors

Sarcomas

Study ID

NCT07374848

Start date

Mar 2, 2026

Status verified date

Feb, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

180 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ZL-6201

ZL-6201 as a single agent

Interventions

ZL-6201

ZL-6201 as a single-agent

Primary outcome measure

  • Incidence of Dose Limiting Toxicities [ Time Frame: 1 cycle of study treatment (each cycle is 21 days) ]
  • Incidence of Treatment Emergent Adverse Events [ Time Frame: 36 months ]
  • Incidence of Serious adverse events [ Time Frame: 36 months ]
  • Number of participants with clinical laboratory abnormalities [ Time Frame: 36 months ]
  • Number of participants with vital sign abnormalities [ Time Frame: 36 months ]
  • Number of participants with electrocardiogram (ECG) abnormalities [ Time Frame: 36 months ]

Central Contacts and Locations

Central contacts

ZL-6201-001 Study Team

650.360.1601ZL-6201-001@zailaboratory.com

Locations

Zai Lab Site 02003

Recruiting

Los Angeles, California, United States, 90007

Zai Lab Site 02030

Recruiting

New Haven, Connecticut, United States, 06510

Zai Lab Site 02026

Recruiting

Sarasota, Florida, United States, 34232

Zai Lab Site 02005

Recruiting

St Louis, Missouri, United States, 63160

Zai Lab Site 02002

Recruiting

New York, New York, United States, 10065

Zai Lab Site 02006

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Zai Lab (Shanghai) Co., Ltd.

Last update posted

Jul 23, 2026

Last verified

Feb, 2026

Keywords

  • Sarcoma
  • Solid Tumors
  • Phase1
  • Antibody-Drug Conjugate (ADC)
  • Leucine-Rich Repeat-Containing protein 15 (LRRC15)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Zai Lab (Shanghai) Co., Ltd. on 2026-07-23.