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Advanced Solid TumorPhase 1NCT05065710

A Study of ZL-1211 in Patients With Advanced Solid Tumor

A Phase 1 study testing ZL-1211 in people with Advanced Solid Tumor, run by Zai Biopharmaceutical (Suzhou) Co., Ltd. at 21 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a Phase I/II, open-label, dose escalation, and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetic (PK), pharmacodynamics (PD), immunogenicity, and preliminary antitumor activity of ZL-1211 administered by IV infusion on a every 2 weeks (Q2W) schedule. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
ZL-1211
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
21 sitesin 2 countries
Study dates
19 Jan 2022to 9 Apr 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients are eligible to be included in the study only if all the following inclusion criteria apply:
  • Adults≥ 18 years of age.
  • Willing and able to provide signed and dated informed consent prior to any study related procedures and willing and able to comply with all study procedures.
  • All patients from Phase I and Phase II are required to provide tumor tissue for CLDN18.2 IHC assessment, and only patients with CLDN18.2-positive tumors will be included in this study.
  • Patients with histologically or cytologically confirmed metastatic or locally advanced solid tumors, refractory to standard treatment
  • Evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
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  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Adequate hepatic function
  • Total bilirubin ≤ 1.5 × upper limit of normal (ULN).
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; AST or ALT ≤ 5 × ULN if liver metastases are present.
  • Adequate renal function, as defined by serum creatinine < 1.5 × ULN OR calculated creatinine CL > 40 mL/min, Cockroft-Gault Equation:
  • Hematological function defined as:
  • Absolute neutrophil count ≥ 1.5 × 109/L without growth factor support in the 2 weeks prior to screening.
  • Platelet count ≥ 100 × 109/L without transfusion in the 2 weeks prior to screening.
  • Hemoglobin ≥ 9 g/dL without transfusion in the 2 weeks prior to screening.
  • Prothrombin time, international normalized ratio or/and activated partial thromboplastin time < 1.5 × ULN.
  • Recovery, to Grade 0-1, from AEs related to prior anticancer therapy except alopecia, < Grade 2 sensory neuropathy, lymphopenia.

Who cannot join

  • Patient with known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome related illness or known active or chronic hepatitis B virus infection or hepatitis C virus.
  • Any uncontrolled active infection.
  • Previous exposure to any CLDN18.2 antibody or CLDN18.2 chimeric antigen receptor T cell therapy.
  • Newly diagnosed or symptomatic brain metastases anticonvulsants are allowed.
  • Severe cardiovascular disease; New York Heart Association Class II-IV heart failure within 6 months of screening; uncontrolled arrhythmia within 6 months of screening.
  • Anticancer therapy or radiation therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to screening; palliative radiotherapy within 2 weeks prior to screening.
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  • Major surgery within 4 weeks prior to first dose; minor surgery within 2 weeks prior to first dose.
  • Symptomatic intrinsic lung disease (chronic obstructive pulmonary disease, pulmonary fibrosis).
  • Gastrointestinal abnormalities including:
  • Documented unresolved gastric outlet obstruction or persistent vomiting defined as ≥ 3 episodes within 24 hours.
  • Active peptic ulcer disease required treatment in the past 3 months.
  • Gastrointestinal bleeding as evidenced by hematemesis, hematochezia, or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy.
  • Documented active colitis within 4 weeks prior to study entry, including infectious colitis, radiation colitis and ischemic colitis.
  • History of ulcerative colitis or Crohn's disease.
  • Patient has received systemic immunosuppressive therapy, including systemic corticosteroids 2 weeks prior to first dose of study drug.

Trial locations and contacts

21 sites in 2 countries.

21 sites in 2 countries

China11 sites

  • Zai Lab Site 1548

    Beijing, Beijing Municipality, 100032

  • Zai Lab Site 1712

    Chengdu, Sichuan, 610044

  • Zai Lab Site 1529

    Hangzhou, Zhejiang, 310003

  • Zai Lab Site 1714

    Hangzhou, Zhejiang, 310014

  • Zai Lab Site 1551

    Harbin, Heilongjiang, 150000

  • Zai Lab Site 1725

    Hefei, Anhui, 230031

  • Zai Lab Site 1539

    Jinan, Shandong, 250014

  • Zai Lab Site 1542

    Shanghai, Shanghai Municipality, 200092

  • Zai Lab Site 1537

    Wuhan, Hubei, 430022

  • Zai Lab Site 1549

    Zhengzhou, Henan, 450003

  • Zai Lab Site 1202

    Zhengzhou, Henan, 450052

Other trials in China

United States10 sites

  • Zai Lab Site 2015

    Cincinnati, Ohio, 45219

  • Zai Lab Site 2023

    Fairfax, Virginia, 22031

  • Zai Site 2020

    Hackensack, New Jersey, 07601

  • Zai Lab Site 2014

    Indianapolis, Indiana, 46250

  • Zai Lab Site 2016

    Lynwood, California, 90262

  • Zai Lab Site 2011

    Nashville, Tennessee, 37203

  • Zai Lab Site 2025

    New York, New York, 10016

  • Zai Lab Site 2012

    Scottsdale, Arizona, 85258

  • Zai Lab Site 2013

    Spokane, Washington, 99208

  • Zai Lab Site 2022

    Tacoma, Washington, 98405

Other trials in United States

About this study

Official title: A Phase I, First-in-Human, Open-Label, Dose Escalation Study of ZL- 1211 in Patients With Unresectable or Metastatic Solid Tumor

This study is a Phase I/II, open-label, dose escalation, and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetic (PK), pharmacodynamics (PD), immunogenicity, and preliminary antitumor activity of ZL-1211 administered by IV infusion on a every 2 weeks (Q2W) schedule.

Read the detailed description

The study consists of two stages, Phase I -Dose Escalation Phase to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) (if no MTD is defined) of ZL-1211, and Phase II -Cohort Expansion Phase to further define the safety and initial antitumor activity of ZL-1211 with the dose established in the Dose Escalation Phase. The trial was intended to be a Phase 1/2 trial but the Phase 2 was not initiated.

Being tested
ZL-1211
Keywords
CLDN18.2, Solid tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZL-1211Drug

    Phase 1 dose escalation part will enroll about 12-42 patients, Phase 2 dose expansion part will enroll about 15-40 patients in each cohort

Study groups in NCT05065710
Study groupRoleWhat they receive
ZL-1211 monotherapyExperimentalNot described
Receives: Drug: ZL-1211

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I ：MTD or MAD

    To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) (if no MTD is defined) of ZL-1211

    Measured: One month

  2. Phase I and Phase II: safety and tolerability

    Incidence of Treatment-Related Adverse Events as Assessed by CTCAE v5.0

    Measured: Approximately 10 months

  3. Phase II: preliminary antitumor activity

    Objective response rate defined as the proportion of patients with partial response (PR) proportion of patients with partial response (PR) or complete response (CR) based on Investigator assessment of tumor lesions per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: Approximately 10 months

Secondary outcomes (10)

  1. Phase I and Phase II: pharmacokinetics (PK):AUC

    Area under the curve (AUC)

    Measured: Approximately 10 months

  2. Phase I and Phase II: pharmacokinetics (PK):Cmax

    Maximum serum concentration (Cmax)

    Measured: Approximately 10 months

  3. Phase I and Phase II: pharmacokinetics (PK):Tmax

    Time to reach Cmax (Tmax)

    Measured: Approximately 10 months

  4. Phase I and Phase II: pharmacokinetics (PK):Ctrough

    Ctrough

    Measured: Approximately 10 months

  5. Phase I and Phase II: pharmacokinetics (PK):Vss

    Volume of distribution at steady state (Vss)

    Measured: Approximately 10 months

  6. Phase I and Phase II: pharmacokinetics (PK):CL

    Clearance (CL)

    Measured: Approximately 10 months

  7. Phase I and Phase II: pharmacokinetics (PK):t1/2

    Half-life (t1/2)

    Measured: Approximately 10 months

  8. Phase I and Phase II: immunogenicity

    Incidence of anti-drug antibodies (ADAs)

    Measured: Approximately 10 months

  9. Phase I and Phase II: immunogenicity

    Quantity of anti-drug antibodies (ADAs)

    Measured: Approximately 10 months

  10. Phase II: preliminary antitumor activity

    Duration of response (DOR), defined as the time from the first date of objective response (CR or PR) to the first documented date of disease progression per RECIST v1.1 or the date of death due to any cause, whichever occurs first

    Measured: Approximately 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2021
  2. Study start19 Jan 2022
  3. Primary completion9 Mar 2024
  4. Study completion9 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Phase I, the Dose Escalation Phase of the study will enroll patients with locally advanced or metastatic solid tumors of any histology with positive CLDN18.2. Phase II, the Cohort Expansion Phase of the study, will be conducted after determination of the dose level (RP2D) for cohort expansion based on the results of Phase I to explore the preliminary efficacy.
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05065710
Sponsor's protocol ID
ZL-1211-001
Status last verified
Aug 2024
First submitted
12 Sep 2021
Last updated
3 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Konno H, Lin T, Wu R, Dai X, Li S, Wang G, Chen M, Li W, Wang L, Sun BC, Luo Z, Huang T, Chen Y, Zhang J, Ye Q, Bellovin D, Wan B, Kang L, Szeto C, Hsu K, Kabbarah O. ZL-1211 Exhibits Robust Antitumor Activity by Enhancing ADCC and Activating NK Cell-mediated Inflammation in CLDN18.2-High and -Low Expressing Gastric Cancer Models. Cancer Res Commun. 2022 Sep 7;2(9):937-950. doi: 10.1158/2767-9764.CRC-22-0216. eCollection 2022 Sep.

    PubMed 36922936

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ZL-1211 in people with Advanced Solid Tumor, run by Zai Biopharmaceutical (Suzhou) Co., Ltd. at 21 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in China, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I ：MTD or MAD (time frame: One month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05065710, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.

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