Exploratory Study on the Efficacy and Safety of Trastuzumab Rezetecan in the Treatment of HER2-Expressiong Advanced Solid Tumor

NCT07631884 | Not Yet Recruiting Phase 2

• 1 other identifier: JY2026-039
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if Trastuzumab Rezetecan can treat advanced solid tumors with HER-2 expression in adult participants. The main question it aims to answer is: What is the objective response rate of Trastuzumab Rezetecan in adult patients with HER-2 expressed advanced solid tumors? Participants will receive intravenous infusion of Trastuzumab Rezetecan on Day 1 of each 21-day treatment cycle. The dosage is 4.8 mg/kg per cycle; participants with a body weight of 85 kg or above will receive a fixed dose of 408 mg every 3 weeks.

Conditions

Solid Tumors; Locally Advanced Malignant Solid Neoplasm; Unresectable Malignant Solid Neoplasm; HER2 Expression; Biliary Tract Neoplasms; Endometrial Neoplasms; Urothelial Carcinoma (UC); Pancreatic Neoplasms; Gastric Neoplasms; Head and Neck Neoplasms; Cervical Neoplasms; Neoplasms (Cancer / Tumors); Advanced Malignant Solid Neoplasm; Colorectal Neoplasms; Non-Small Cell Lung Carcinoma (NSCLC); Metastatic Malignant Solid Neoplasm

Keywords

HER2 expression; Trastuzumab Rezetecan; Advanced Solid Tumor

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 (8)

• 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.

• Progression-Free Survival, PFS

  Through study completion, an average of 2 years.

• Overall Survival, OS

  Through study completion, an average of 2 years.

• 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.

Study Arms (1)

Trastuzumab Rezetecan

EXPERIMENTAL

Participants will receive intravenous infusion of Trastuzumab Rezetecan on Day 1 of each 21-day treatment cycle. The dosage is 4.8 mg/kg per cycle; participants with a body weight of 85 kg or above will receive a fixed dose of 408 mg every 3 weeks.

Drug: Trastuzumab Rezetecan

Interventions

Trastuzumab Rezetecan DRUG

Trastuzumab Rezetecan will be administered on Day 1 of each 21-day cycle as specified. The dose is 4.8 mg/kg (fixed 408 mg for body weight ≥85 kg). Treatment continues until tumor progression or occurrence of unacceptable toxicity.

Trastuzumab Rezetecan

Eligibility Criteria

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

You may qualify if:

• Male and female participants aged 18 years or older.
• Participants with locally advanced, unresectable or metastatic solid tumors who have progressed after at least one prior systemic therapy for advanced/metastatic disease, or have no satisfactory alternative treatment options. Eligible tumor types include but are not limited to biliary tract cancer, endometrial cancer, urothelial carcinoma, pancreatic cancer, colorectal cancer, gastric cancer, non-small cell lung cancer, head and neck adenocarcinoma (salivary gland adenocarcinoma, lacrimal gland adenocarcinoma, adenocarcinoma of unknown primary in the neck), cervical cancer, ovarian cancer and adenocarcinoma of unknown primary. Breast cancer is excluded.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
• Confirmed HER2 expression defined as IHC 1+, 2+ or 3+ (per GC criteria).
• Willing and able to provide adequate tumor specimens for central pathological re-testing of HER2 status. For participants previously treated with anti-HER2 therapy, tumor specimens obtained after the last anti-HER2 treatment are optional.
• At least one measurable lesion at baseline per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• Adequate organ and bone marrow function within 14 days prior to enrollment, meeting the following criteria:
• Hemoglobin ≥ 9 g/dL; Platelet count ≥ 100,000/mm³; Absolute neutrophil count (ANC) ≥ 1500/mm³; Serum albumin ≥ 3.0 g/dL; Prothrombin time (PT), activated partial thromboplastin time (aPTT) and International Normalized Ratio (INR) ≤ 1.5 × upper limit of normal (ULN); Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 × ULN; ≤ 5 × ULN for participants with liver metastases; Total bilirubin ≤ 1.5 × ULN for participants without liver metastases; ≤ 3 × ULN for participants with Gilbert's syndrome or liver metastases at baseline; Creatinine clearance ≥ 30 mL/min (calculated by the Cockcroft-Gault formula)
• Left ventricular ejection fraction (LVEF) ≥ 50% assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days prior to enrollment.

You may not qualify if:

• Participants meeting any of the following conditions are ineligible for this study:
• Presence of any severe and/or uncontrolled diseases:
• Poorly controlled blood pressure (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); poorly controlled diabetes (fasting blood glucose \[FBG\] \> 10 mmol/L).
• Grade ≥ 2 myocardial ischemia, myocardial infarction, arrhythmia (QTc interval ≥ 470 ms), or Grade ≥ 2 congestive heart failure (per New York Heart Association \[NYHA\] classification).
• Active or uncontrolled severe infections (Grade ≥ 2 per NCI CTCAE) requiring systemic antibacterial, antifungal or antiviral therapy, including pulmonary tuberculosis.
• History of active tuberculosis.
• Uncontrolled ascites, pericardial effusion or pleural effusion requiring repeated drainage.
• History of immunodeficiency diseases, including HIV positivity or other acquired/congenital immunodeficiency disorders.
• History of allogeneic solid organ transplantation or allogeneic hematopoietic stem cell transplantation.
• Confirmed meningeal metastasis, spinal cord metastasis or spinal cord compression.
• Within 6 months prior to the first study drug administration, presence of esophageal gastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, acute gastrointestinal bleeding, extensive intestinal resection (partial colectomy or extensive small bowel resection complicated with chronic diarrhea), Crohn's disease, ulcerative colitis or long-standing chronic diarrhea.
• Unhealed or poorly healing wounds, or active ulcers.
• Toxicities from prior anti-tumor therapy have not resolved to Grade 0 or 1 per NCI CTCAE version 5.0.
• Received major surgery, incisional biopsy or significant traumatic injury within 28 days before study treatment initiation; or with long-standing unhealed wounds or fractures.
• History of severe hypersensitivity reactions to monoclonal antibodies; known allergy to the active ingredients or excipients of the study drug.

Sponsors & Collaborators

• Haihua Yuan: lead

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis; Biliary Tract Neoplasms; Endometrial Neoplasms; Carcinoma, Transitional Cell; Pancreatic Neoplasms; Colorectal Neoplasms; Stomach Neoplasms; Carcinoma, Non-Small-Cell Lung; Head and Neck Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Biliary Tract Diseases; Digestive System Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; 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; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Stomach Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Uterine Cervical Diseases

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 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, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share