NCT07374848

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_1

Timeline
41mo left

Started Mar 2026

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Mar 2026Sep 2029

First Submitted

Initial submission to the registry

December 15, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

March 5, 2026

Status Verified

February 1, 2026

Enrollment Period

2.4 years

First QC Date

December 15, 2025

Last Update Submit

March 4, 2026

Conditions

Solid TumorsSarcomas

Keywords

SarcomaSolid TumorsPhase1Antibody-Drug Conjugate (ADC)Leucine-Rich Repeat-Containing protein 15 (LRRC15)

Outcome Measures

Primary Outcomes (6)

  • 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)

  • 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

Secondary Outcomes (6)

  • ORR per RECIST 1.1

    36 months

  • Duration of Response per RECIST 1.1

    36 months

  • PFS per RECIST 1.1

    36 months

  • DCR per RECIST 1.1

    36 months

  • PK characteristics of ZL-6201 (ADC conjugate), total antibody

    36 months

  • +1 more secondary outcomes

Study Arms (1)

ZL-6201

EXPERIMENTAL

ZL-6201 as a single agent

Drug: ZL-6201

Interventions

ZL-6201DRUG

ZL-6201 as a single-agent

ZL-6201

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zai Lab Site 02026

Sarasota, Florida, 34232, United States

RECRUITING

Zai Lab Site 02006

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Central Study Contacts

ZL-6201-001 Study Team

CONTACT

(510)-316-3502ZL-6201-001@zailaboratory.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2025

First Posted

January 29, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

September 1, 2029

Last Updated

March 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)