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

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: Recruiting
• Conditions: Solid Tumors; Sarcomas
• Intervention / Treatment: Drug: ZL-6201

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: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: ZL-6201-001 Study Team; Phone Number: (510)-316-3502; Email: ZL-6201-001@zailaboratory.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90007
      • Recruiting
      • Zai Lab Site 02003
  • 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment Emergent Adverse Events	Number of subjects with treatment-emergent adverse effects through dose escalation and expansion.	36 months
Incidence of Serious adverse events	Number of subjects with Serious Adverse Events through dose escalation and expansion.	36 months
Number of participants with clinical laboratory abnormalities		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	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.	36 months
Incidence of Dose Limiting Toxicities	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

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	36 months
PK characteristics of ZL-6201 (ADC conjugate), total antibody	Pharmacokinetics: Total Antibody of ZL-6201	36 months
PK characteristics of ZL-6201 (ADC conjugate), unconjugated payloads	Pharmacokinetics: Unconjugated payloads of ZL-6201	36 month

Collaborators and Investigators

• Sponsor: Zai Lab (Shanghai) Co., Ltd.
• Collaborators: Zai Lab (US) LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Solid Tumors; Sarcoma; Phase1; Antibody-Drug Conjugate (ADC); Leucine-Rich Repeat-Containing protein 15 (LRRC15)
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Sarcoma
• Other Study ID 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