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Recruiting NCT07374848

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

Phase I Interventional Solid Tumors Sarcomas

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ZL-6201.
Who it may be relevant to
Registry conditions: Solid Tumors, Sarcomas. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

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

Interventions

  • Drug ZL-6201
    ZL-6201 as a single-agent

Primary outcome measures

  • 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]
Secondary outcome measures (6)
  • ORR per RECIST 1.1 [Time frame: 36 months]
  • Duration of Response per RECIST 1.1 [Time frame: 36 months]
  • PFS per RECIST 1.1 [Time frame: 36 months]
  • DCR per RECIST 1.1 [Time frame: 36 months]
  • PK characteristics of ZL-6201 (ADC conjugate), total antibody [Time frame: 36 months]
  • PK characteristics of ZL-6201 (ADC conjugate), unconjugated payloads [Time frame: 36 month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 6 centers
  • Zai Lab Site 02003 — Los Angeles
  • Zai Lab Site 02030 — New Haven
  • Zai Lab Site 02026 — Sarasota
  • Zai Lab Site 02005 — St Louis
  • Zai Lab Site 02002 — New York
  • Zai Lab Site 02006 — Fairfax
China · 2 centers
  • Cancer Hospital Chinese Academy of Medical Sciences — Beijing
  • Shanghai East Hospital — Shanghai

Identifiers

NCT: NCT07374848 · ZL-6201-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗