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HER2-positive Advanced Solid TumorPhase 1NCT05423977

Study of ZV0203 in Patients With HER2-Positive Advanced Solid Tumors

A Phase 1 study testing ZV0203 in people with HER2-positive Advanced Solid Tumor, run by Hangzhou Adcoris Biopharmacy Co., Ltd at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

An open-label, multicenter, phase I dose-escalation study to assess the safety, Pharmacokinetic (PK), immunogenicity and preliminary anti-tumor activity of ZV0203 in patients with HER2-Positive advanced solid tumors Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HER2-positive Advanced Solid Tumor
What is being tested?
ZV0203
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
17 Dec 2021to 7 Jul 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • Being willing and capable of signing a written informed consent form (ICF).
  • Aged ≥18 or older at the time of signing the ICF.
  • Pathologically diagnosed as having an unresectable locally advanced or metastatic solid tumors, refractory or intolerant to standard therapy, or with no standard therapy available.
  • Having HER2-positive disease, i.e. HER2 positive by in situ hybridization on previously collected tumor tissue and/or immunohistochemistry of 3+.
  • The Eastern Cooperative Oncology Group Performance Status (ECOG) performance status score is 0 or 1.
  • Echocardiography (ECHO) or multi-gated acquisition (MUGA) scan shows a left ventricular ejection fraction of ≥ 50%.
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  • Good hematology and end-organ function, with laboratory results within 14 days prior to the first study treatment (Cycle 1, Day 1) meeting the following criteria:
  • Absolute neutrophil count ≥ 1,500/mm3
  • Platelet count ≥ 100,000/mm3 and no transfusion within 14 days after obtaining a hematology laboratory sample at screening
  • Hemoglobin ≥ 9.0 g/dL
  • Total bilirubin ≤ 1.5 ×upper limit of normal (ULN); subjects with confirmed/suspected Gilbert's disease, bilirubin ≤ 3 × ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × ULN; ≤ 5 × ULN if there is liver metastasis
  • Serum creatinine ≤ 1.5 × ULN or estimated glomerular filtration rate > 40 mL/min/1.73 m2
  • Prothrombin time and activated partial thromboplastin time ≤ 1.5 × ULN. It is applicable only to subjects who have received no therapeutic anticoagulant therapy and subjects who have received therapeutic anticoagulant therapy at a stable dose.
  • The investigator determined that the life expectancy of the subjects is ≥12 weeks.
  • For women of childbearing potential, their pregnancy test must be negative for enrollment, and they must agree to take highly effective contraceptive measures when enrolled, during treatment and 90 days after the last dose of the investigational drug (see section 6.1.3). Women are considered to be of childbearing potential from menarche to menopause (after at least 12 months without menstruation) unless they are permanently infertile (due to hysterectomy, bilateral salpingectomy or bilateral oophorectomy).
  • For men, they must be surgically sterile or agree to take highly effective contraceptive measures when enrolled, during treatment and 90 days after the last dose of the investigational drug (see section 6.1.3 ).

Who cannot join

  • Subjects with symptomatic brain metastases or soft meningeal disease known to require steroid therapy. Subjects diagnosed with brain metastases in the past can participate in the study if they have completed the treatment, recovered from the acute reaction of radiotherapy or surgery prior to enrollment, have discontinued the use of corticosteroids for the treatment of these metastases, and have been clinically stable and neurologically stable without anticonvulsants for at least 4 weeks prior to enrollment.
  • Subjects who are suffering from uncontrolled or major cardiovascular disease, including any of the following circumstances:
  • Baseline QT Interval Corrected Using Fridericia's Formula >450 msec or congenital long QT syndrome.
  • Subjects who have a history of symptomatic congestive heart failure or current symptomatic congestive heart failure (NYHA Grade III-IV) or severe arrhythmias requiring treatment.
  • Subjects who have a history of myocardial infarction or unstable angina within 6 months prior to first dose of ZV0203.
  • Subjects who have a clinically significant resting bradycardia (< 50 beats/min).
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  • Subjects who have a history of grade II (Mobitz II) or grade III cardiac conduction block (subjects with pacemakers may participate in this study if they have no history of syncope or clinically relevant arrhythmias during pacemaker use).
  • Subjects who have a history of complete left bundle branch block.
  • Subjects who have a history of clinically significant lung disease (e.g., interstitial pneumonia, pulmonary fibrosis, and severe radiation pneumonia) or suspicion of these diseases by imaging at screening.
  • Subjects who have a history of ocular abnormalities and judged to be ineligible for enrollment by the investigator.
  • Subjects who have received any anticancer treatment or investigational therapy within 4 weeks prior to the first dose of ZV0203.
  • Subjects who have received hormone therapy within 14 days prior to the first dose of ZV0203, except hormone therapy for non-cancer related conditions (e.g. alternative therapies of insulin and hormone for diabetes).
  • Subjects who have undergone major surgery or scheduled surgery for any reason within 4 weeks prior to screening or those the investigator believe may require surgery.
  • Toxicity of prior anticancer therapy does not improve to NCI-CTCAE V5.0 Grade 0 or 1, except for alopecia and laboratory values listed according to the inclusion criteria.
  • Subjects who have a history of other malignancies, except adequately treated non-melanoma skin cancer, radically treated in situ disease or other solid tumors that have been radically treated and free of evidence of disease for at least 2 years.
  • Subjects who are suffering an active infection that is difficult to control with systemic therapy.
  • Subjects who are suffering known active clinically relevant liver disease (e.g., active hepatitis B or active hepatitis C).
  • Subjects who are known to have a history of human immunodeficiency virus infection.
  • Subjects who are suffering a concomitant disease that may increase the risk of toxicity in the judgment of the investigator.
  • Subjects who are known to be allergic to any component of ZV0203.
  • Subjects who have a history of intolerance to pertuzumab or Trastuzumab emtansine (e.g. grade 3 or grade 4 infusion-related reactions).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • PKUCare Luzhong Hospital

    Zigong, Shandong

Other trials in China

About this study

Official title: An Open-label, Multicenter, Phase I Dose-escalation Study to Assess the Safety, Pharmacokinetic (PK), Immunogenicity and Preliminary Anti-tumor Activity of ZV0203 in Patients With HER2-Positive Advanced Solid Tumors

An open-label, multicenter, phase I dose-escalation study to assess the safety, Pharmacokinetic (PK), immunogenicity and preliminary anti-tumor activity of ZV0203 in patients with HER2-Positive advanced solid tumors

Being tested
ZV0203
Keywords
Advanced Solid Tumor, HER2-positive

What participants receive

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

  • ZV0203Drug

    Participants will be allocated to one of the following dose groups: 0.3, 0.6, 1.2, 1.8, 2.7 and 3.6 mg/kg, and receive a treatment of ZV0203-ADC followed by 21 days of dose limited toxicity (DLT) observation period.

Study groups in NCT05423977
Study groupRoleWhat they receive
Experimental:ZV0203ExperimentalNot described
Receives: Drug: ZV0203

What is being measured

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

  1. Frequency of adverse events (AEs) and serious adverse events (SAEs)

    To investigate the safety characteristics.

    Measured: From the day of ICF sign to 30 days after the day of the last treatment

  2. Maximum Tolerated dose of ZV0203

    To determine the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D) of ZV0203.

    Measured: 21 days after first treatment

Secondary outcomes (8)

  1. Pharmacokinetic (PK) parameter of Peak plasma Concentration (Cmax)

    To assess the pharmacokinetic profile in patients with advanced solid tumors

    Measured: 45 days

  2. Pharmacokinetic (PK) parameter of Peak plasma Concentration (Tmax)

    To assess the pharmacokinetic profile in patients with advanced solid tumors

    Measured: 45 days

  3. Pharmacokinetic (PK) parameter the area under the plasma concentration-time curve from time zero to the last measurable time point (AUC0-t)

    To assess the pharmacokinetic profile in patients with advanced solid tumors

    Measured: 45 days

  4. Objective response rate (ORR)

    The objective response rate in patients of advanced solid tumors

    Measured: Approximately 1 year

  5. Duration control rate (DCR)

    The duration control rate in patients of advanced solid tumors

    Measured: Approximately 1 year

  6. Duration of response (DOR)

    The duration of response in patients of advanced solid tumors

    Measured: Approximately 1 year

  7. Progression-free survival (PFS)

    The progression-free survival in patients of advanced solid tumors

    Measured: Approximately 1 year

  8. Immunogenicity assessment

    The endpoints for ZV0203 immunogenicity assessment include the number and percentage of subjects with detectable drug-resistant antibodies.

    Measured: 45 days

Timeline

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

  1. First posted21 Jun 2022
  2. Study start17 Dec 2021
  3. Primary completion5 May 2023
  4. Study completion7 Jul 2026 (estimated)

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
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05423977
Sponsor's protocol ID
ZV0203-001CN
Status last verified
Mar 2025
First submitted
14 Jan 2022
Last updated
30 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ZV0203 in people with HER2-positive Advanced Solid Tumor, run by Hangzhou Adcoris Biopharmacy Co., Ltd at 1 site in China.

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 21 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: enrolling by invitation, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

This study is still under way. Results are not available in the source record yet.

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?

Frequency of adverse events (AEs) and serious adverse events (SAEs) (time frame: From the day of ICF sign to 30 days after the day of the last treatment). The study lists 2 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 NCT05423977.

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 30 Sep 2025.

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