NeoplasmsPhase 2NCT07631871
An Exploratory Study of Zanidatamab in HER2-positive Advanced Tumor After at Least One Line of Standard Therapy
A Phase 2 study testing Zanidatamab in people with Neoplasms and Solid Tumors, run by Haihua Yuan.
Trial summary
The goal of this clinical trial is to learn if Zanidatamab can treat HER2-positive advanced tumors in adults. The main question it aims to answer is: What is the objective response rate of Zanidatamab in adult patients with HER-2 positive advanced solid tumors? Participants will receive Zanidatamab intravenously on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Solid Tumors, HER2 Positive Solid Tumor
- What is being tested?
- Zanidatamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 31 Dec 2029
- Phase
- Phase 2
- 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
- Male or female subjects aged ≥ 18 years old.
- Subjects with locally advanced, unresectable or metastatic solid tumors who have progressed after ≥1 prior systemic therapy for advanced/metastatic disease, or have no available optimal alternative treatments. Qualified tumor types include but are not limited to endometrial carcinoma, urothelial carcinoma, pancreatic cancer, colorectal carcinoma (CRC), head and neck adenocarcinoma (salivary gland adenocarcinoma, lacrimal gland adenocarcinoma, adenocarcinoma of unknown primary of the neck), cervical cancer, ovarian cancer and adenocarcinoma of unknown primary. Biliary tract malignancy, lung cancer and breast cancer are excluded. For CRC patients: documented RAS status (wild-type or mutant) and wild-type BRAF; prior treatment regimen should contain fluoropyrimidine, oxaliplatin and irinotecan unless contraindicated; anti-VEGF therapy when clinically indicated; anti-PD-L1 therapy for MSI-H/dMMR tumors if clinically indicated.
- ECOG Performance Status 0, 1 or 2.
- Confirmed HER2 positivity defined as IHC 3+, or IHC 2+ with positive FISH amplification (per GC criteria).
- Willing and capable of providing adequate tumor specimens for central pathological re-assessment of HER2 status at institutional pathology department. Patients previously treated with HER2-ADC must provide FFPE tumor samples collected after last HER2-ADC administration. Specimens with insufficient tumor cellularity and fine-needle aspiration samples are not acceptable for HER2 testing.
- At least one measurable lesion at baseline per RECIST 1.1 criteria.
- Adequate bone marrow and organ function confirmed within 14 days prior to enrollment: Hemoglobin ≥ 9 g/dL; Platelet count ≥ 75,000/mm³; Absolute neutrophil count (ANC) ≥ 1000/mm³; Serum albumin ≥ 2.5 g/dL; PT, aPTT and INR ≤ 1.5 × ULN; AST/ALT ≤ 3 × ULN; ≤5 × ULN for subjects with liver metastasis; Total bilirubin ≤1.5 × ULN (no liver metastasis); ≤3 × ULN (baseline Gilbert syndrome or liver metastasis); Creatinine clearance ≥30 mL/min (calculated by Cockcroft-Gault formula)
- LVEF ≥50% evaluated via echocardiogram (ECHO) or MUGA scan within 28 days before enrollment.
Who cannot join
- Subjects with any of the following conditions are ineligible:
- Documented spinal cord compression, leptomeningeal disease or clinically active central nervous system (CNS) metastasis.
- Active primary immunodeficiency, confirmed HIV infection, active HBV or HCV infection.
- History of non-infectious interstitial lung disease (ILD)/non-infectious pneumonia requiring steroid therapy, ongoing active ILD/non-infectious pneumonia, or suspected ILD/non-infectious pneumonia that cannot be ruled out by screening imaging.
- History of myocardial infarction, symptomatic congestive heart failure (CHF, NYHA Class II-IV), unstable angina, or any cardiovascular event (including stroke) within 6 months prior to enrollment.
- Pulmonary exclusion items: (a) Clinically significant underlying pulmonary disorders, including but not limited to pulmonary embolism within 3 months before screening, severe asthma, severe COPD, restrictive lung disease, recurrent pleural effusion; (b) Confirmed autoimmune, connective tissue or inflammatory diseases (rheumatoid arthritis, Sjögren's syndrome, sarcoidosis etc.), or suspected pulmonary involvement at screening; full disease details shall be recorded in eCRF for enrolled subjects; (c) Previous total pneumonectomy.
- Confirmed presence of HER2 gene mutation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to learn if Zanidatamab can treat HER2-positive advanced tumors in adults. The main question it aims to answer is: What is the objective response rate of Zanidatamab in adult patients with HER-2 positive advanced solid tumors? Participants will receive Zanidatamab intravenously on Day 1 of each 2-week treatment cycle. The dosage is 20 mg/kg per cycle.
- Conditions
- Neoplasms, Solid Tumors, HER2 Positive Solid Tumor, Endometrial Neoplasm, Urothelial Carcinoma (UC), Pancreatic Neoplasms
- Being tested
- Zanidatamab
- Keywords
- HER2 Positive Solid Tumor, Zanidatamab, Basket Study
- Medical subject headings
- Neoplasms, Endometrial Neoplasms, Carcinoma, Transitional Cell, Pancreatic Neoplasms, Colorectal Neoplasms, Head and Neck Neoplasms, Uterine Cervical Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanidatamabDrug
Treatment continues until disease progression, intolerable toxicity, subject withdrawal or study termination.
| Study group | Role | What they receive |
|---|---|---|
| Zanidatamab | Experimental | Zanidatamab is administered intravenously at a dose of 20 mg/kg on Day 1 of every 2-week treatment cycle. Receives: Drug: Zanidatamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate, ORR
The Objective Response Rate (ORR) is defined as the percentage of patients whose best response on or before the first occurrence of disease progression is a complete response (CR) or partial response (PR). Tumor responses were assessed by investigators using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: From the date of first study treatment until disease progression or death from any cause, whichever occurs first, assessed up to 24months.
Secondary outcomes (6)
Duration of Response, DOR
Duration of Response (DoR) is defined as the time from the date of first documented response (CR or PR) to date of first occurrence of disease progression as determined by investigators, or death from any cause, whichever occurs first.
Measured: From the date of first documented response (complete response [CR] or partial response [PR]) to the time of disease progression or death from any cause, whichever occurs first, assessed up to 24months.
Disease Control Rate, DCR
Disease Control Rate (DCR) is defined as the proportion of patients whose best response is CR, PR or SD maintained more than 8 weeks. Tumor responses were assessed by investigators using RECIST version 1.1.
Measured: From the date of first study treatment until disease progression or death from any cause, whichever occurs first, assessed up to 24 months.
Best Overall Response, BOR
Best overall response (BOR) is defined as the best tumor response achieved at any time during treatment, categorized as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) per RECIST 1.1 criteria.
Measured: Through study completion, average follow-up of 2 years.
Progression-Free Survival, PFS
Progression-Free Survival (PFS) is defined as the time from the start of study treatment to the first occurrence of disease progression, or death, whichever occurs first. Tumor responses were assessed by investigators using RECIST version 1.1.
Measured: Through study completion, an average of 2 years.
Overall Survival, OS
Overall Survival is defined as the time from the date of the first study treatment to the date of death from any cause.
Measured: Through study completion, an average of 2 years.
Adverse Events, AEs
Incidence, severity (graded per NCI CTCAE version 5.0), and causality of adverse events (AEs).
Measured: From first study drug administration through 40 days after the last dose; overall average follow-up duration is 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a single-arm, exploratory, basket study.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haihua Yuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Haihua Yuan, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631871
- Sponsor's protocol ID
- JY2026-038
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Zanidatamab in HER2-positive Advanced Tumor After at Least One Line of Standard Therapy
- ClinicalTrials.gov ID
- NCT07631871
- Acronym / sponsor ID
- JY2026-038
- Conditions
- Neoplasms, Solid Tumors, HER2 Positive Solid Tumor, Endometrial Neoplasm, Urothelial Carcinoma (UC), Pancreatic Neoplasms
- Keywords
- HER2 Positive Solid Tumor, Zanidatamab, Basket Study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Haihua YuanUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if Zanidatamab can treat HER2-positive advanced tumors in adults. The main question it aims to answer is: What is the objective response rate of Zanidatamab in adult patients with HER-2 positive advanced solid tumors? Participants will receive Zanidatamab intravenously on Day 1 of each 2-week treatment cycle. The dosage is 20 mg/kg per cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a single-arm, exploratory, basket study.
| Arm | Type | Receives |
|---|---|---|
| Zanidatamab | Experimental | Drug: ZanidatamabZanidatamab is administered intravenously at a dose of 20 mg/kg on Day 1 of every 2-week treatment cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects aged ≥ 18 years old.
- Subjects with locally advanced, unresectable or metastatic solid tumors who have progressed after ≥1 prior systemic therapy for advanced/metastatic disease, or have no available optimal alternative treatments. Qualified tumor types include but are not limited to endometrial carcinoma, urothelial carcinoma, pancreatic cancer, colorectal carcinoma (CRC), head and neck adenocarcinoma (salivary gland adenocarcinoma, lacrimal gland adenocarcinoma, adenocarcinoma of unknown primary of the neck), cervical cancer, ovarian cancer and adenocarcinoma of unknown primary. Biliary tract malignancy, lung cancer and breast cancer are excluded. For CRC patients: documented RAS status (wild-type or mutant) and wild-type BRAF; prior treatment regimen should contain fluoropyrimidine, oxaliplatin and irinotecan unless contraindicated; anti-VEGF therapy when clinically indicated; anti-PD-L1 therapy for MSI-H/dMMR tumors if clinically indicated.
- ECOG Performance Status 0, 1 or 2.
- Confirmed HER2 positivity defined as IHC 3+, or IHC 2+ with positive FISH amplification (per GC criteria).
- Willing and capable of providing adequate tumor specimens for central pathological re-assessment of HER2 status at institutional pathology department. Patients previously treated with HER2-ADC must provide FFPE tumor samples collected after last HER2-ADC administration. Specimens with insufficient tumor cellularity and fine-needle aspiration samples are not acceptable for HER2 testing.
Key exclusion criteria (7 listed)
- Documented spinal cord compression, leptomeningeal disease or clinically active central nervous system (CNS) metastasis.
- Active primary immunodeficiency, confirmed HIV infection, active HBV or HCV infection.
- History of non-infectious interstitial lung disease (ILD)/non-infectious pneumonia requiring steroid therapy, ongoing active ILD/non-infectious pneumonia, or suspected ILD/non-infectious pneumonia that cannot be ruled out by screening imaging.
- History of myocardial infarction, symptomatic congestive heart failure (CHF, NYHA Class II-IV), unstable angina, or any cardiovascular event (including stroke) within 6 months prior to enrollment.
- Pulmonary exclusion items: (a) Clinically significant underlying pulmonary disorders, including but not limited to pulmonary embolism within 3 months before screening, severe asthma, severe COPD, restrictive lung disease, recurrent pleural effusion; (b) Confirmed autoimmune, connective tissue or inflammatory diseases (rheumatoid arthritis, Sjögren's syndrome, sarcoidosis etc.), or suspected pulmonary involvement at screening; full disease details shall be recorded in eCRF for enrolled subjects; (c) Previous total pneumonectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZanidatamabTreatment continues until disease progression, intolerable toxicity, subject withdrawal or study termination. | Drug | Zanidatamab |
Primary outcome
Objective Response Rate, ORR
Time frame: From the date of first study treatment until disease progression or death from any cause, whichever occurs first, assessed up to 24months.
The Objective Response Rate (ORR) is defined as the percentage of patients whose best response on or before the first occurrence of disease progression is a complete response (CR) or partial response (PR). Tumor responses were assessed by investigators using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
6 secondary outcomes
Duration of Response, DOR
Time frame: From the date of first documented response (complete response [CR] or partial response [PR]) to the time of disease progression or death from any cause, whichever occurs first, assessed up to 24months.
Disease Control Rate, DCR
Time frame: From the date of first study treatment until disease progression or death from any cause, whichever occurs first, assessed up to 24 months.
Best Overall Response, BOR
Time frame: Through study completion, average follow-up of 2 years.
Progression-Free Survival, PFS
Time frame: Through study completion, an average of 2 years.
Overall Survival, OS
Time frame: Through study completion, an average of 2 years.
Adverse Events, AEs
Time frame: From first study drug administration through 40 days after the last dose; overall average follow-up duration is 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zanidatamab in people with Neoplasms and Solid Tumors, run by Haihua Yuan.
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 8 inclusion and 7 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: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Haihua Yuan (+86-021-56691101-7261, ayuan790415@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate, ORR (time frame: From the date of first study treatment until disease progression or death from any cause, whichever occurs first, assessed up to 24months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2026.