An Exploratory Study of Zanidatamab in HER2-positive Advanced Tumor After at Least One Line of Standard Therapy

NCT07631871 | Not Yet Recruiting Phase 2

• 1 other identifier: JY2026-038
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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 Day 1 of each 2-week treatment cycle. The dosage is 20 mg/kg per cycle.

Conditions

Neoplasms; Solid Tumors; Endometrial Neoplasm; Urothelial Carcinoma (UC); Pancreatic Neoplasms; Cervical Neoplasms; Ovarian Neoplasms; Colorectal Neoplasms; HER2 Positive Solid Tumor; Head and Neck Neoplasms

Keywords

HER2 Positive Solid Tumor; Zanidatamab; Basket Study

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  Through study completion, average follow-up of 2 years.

• Progression-Free Survival, PFS

  Through study completion, an average of 2 years.

• Overall Survival, OS

  Through study completion, an average of 2 years.

Study Arms (1)

Zanidatamab

EXPERIMENTAL

Zanidatamab is administered intravenously at a dose of 20 mg/kg on Day 1 of every 2-week treatment cycle.

Drug: Zanidatamab

Interventions

Zanidatamab DRUG

Treatment continues until disease progression, intolerable toxicity, subject withdrawal or study termination.

Zanidatamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Confirmed presence of HER2 gene mutation.

Sponsors & Collaborators

• Haihua Yuan: lead

MeSH Terms

Conditions

Neoplasms; Endometrial Neoplasms; Carcinoma, Transitional Cell; Pancreatic Neoplasms; Colorectal Neoplasms; Head and Neck Neoplasms; Uterine Cervical Neoplasms; Ovarian Neoplasms

Interventions

zanidatamab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Uterine Cervical Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders

Central Study Contacts

Haihua Yuan

CONTACT

+86-021-56691101-7261; ayuan790415@shsmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor, Chief Physician, Department of Oncology, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Model Details: This study is a single-arm, exploratory, basket study.

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 8, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 8, 2026

Record last verified: 2026-06