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NCT Number: NCT07374848

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

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Key information

Conditions

Solid Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma Sarcomas

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing Municipality, China

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ZL-6201

Drug

ZL-6201 as a single-agent

Primary outcomes

  1. Incidence of Dose Limiting Toxicities

    Time frame: 1 cycle of study treatment (each cycle is 21 days)

    Number of subjects with dose limiting toxicities (DLTs) through dose escalation only.

  2. Incidence of Treatment Emergent Adverse Events

    Time frame: 36 months

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

  3. Incidence of Serious adverse events

    Time frame: 36 months

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

  4. Number of participants with clinical laboratory abnormalities

    Time frame: 36 months

  5. Number of participants with vital sign abnormalities

    Time frame: 36 months

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

  6. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: 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.

Secondary outcomes

  1. ORR per RECIST 1.1

    Time frame: 36 months

    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.

  2. Duration of Response per RECIST 1.1

    Time frame: 36 months

    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.

  3. PFS per RECIST 1.1

    Time frame: 36 months

    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.

  4. DCR per RECIST 1.1

    Time frame: 36 months

    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.

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

    Time frame: 36 months

    Pharmacokinetics: Total Antibody of ZL-6201

  6. PK characteristics of ZL-6201 (ADC conjugate), unconjugated payloads

    Time frame: 36 month

    Pharmacokinetics: Unconjugated payloads of ZL-6201

Study contacts

Contact information is provided by the study sponsor or research team.

ZL-6201-001 Study Team

CONTACT

[email protected]

650.360.1601

Sponsors and collaborators

Lead sponsor

Zai Lab (Shanghai) Co., Ltd.

Industry

Collaborators

  • Zai Lab (US) LLC

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jan 29, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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