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

June 2, 2026 updated by: Haihua Yuan

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male and female participants aged 18 years or older.
  2. 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.
  3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
  4. Confirmed HER2 expression defined as IHC 1+, 2+ or 3+ (per GC criteria).
  5. 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.
  6. At least one measurable lesion at baseline per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  7. 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)

  8. Left ventricular ejection fraction (LVEF) ≥ 50% assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days prior to enrollment.

Exclusion Criteria:

Participants meeting any of the following conditions are ineligible for this study:

  1. 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.
  2. Active hepatitis: Liver function not meeting the inclusion criteria. Hepatitis B: HBV DNA ≥ 2000 IU/mL or ≥ 10^4 copies/mL.Hepatitis C: HCV RNA ≥ 2000 IU/mL or ≥ 10^4 copies/mL. Participants with viral load below the above thresholds after nucleoside antiviral therapy are eligible. Chronic hepatitis B virus carriers with HBV DNA < 10^4 IU/mL must receive concurrent antiviral treatment throughout the study for enrollment.
  3. History of immunodeficiency diseases, including HIV positivity or other acquired/congenital immunodeficiency disorders.
  4. History of allogeneic solid organ transplantation or allogeneic hematopoietic stem cell transplantation.
  5. Confirmed meningeal metastasis, spinal cord metastasis or spinal cord compression.
  6. 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.
  7. Unhealed or poorly healing wounds, or active ulcers.
  8. Toxicities from prior anti-tumor therapy have not resolved to Grade 0 or 1 per NCI CTCAE version 5.0.
  9. Received major surgery, incisional biopsy or significant traumatic injury within 28 days before study treatment initiation; or with long-standing unhealed wounds or fractures.
  10. History of severe hypersensitivity reactions to monoclonal antibodies; known allergy to the active ingredients or excipients of the study drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trastuzumab Rezetecan
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the date of first study treatment until disease progression or death from any cause, whichever occurs first, assessed up to 24months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 the investigator, or death from any cause, whichever occurs first.
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
Time Frame: Through study completion, an average of 2 years.
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.
Through study completion, an average of 2 years.
Overall Survival, OS
Time Frame: Through study completion, an average of 2 years.
Overall Survival (OS) is defined as the time from the date of the first study treatment (Day 1) to the date of death from any cause.
Through study completion, an average of 2 years.
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.
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.
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.
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.
Through study completion, average follow-up of 2 years.
Time to Response, TTR
Time Frame: Through study completion.
Time to response (TTR) is defined as the time from the date of first study drug administration to the date of first documented and confirmed CR or PR per RECIST 1.1.
Through study completion.
Patient-reported outcomes, PROs
Time Frame: Baseline and every 12 weeks during treatment.
Patient-reported quality of life changes measured by the EORTC QLQ-C30 questionnaire. Questionnaires are completed at baseline and repeated every 12 weeks during treatment to evaluate changes in patients' quality of life over time.
Baseline and every 12 weeks during treatment.
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.
Incidence, severity (graded per NCI CTCAE version 5.0), and causality of adverse events (AEs).
From first study drug administration through 40 days after the last dose; overall average follow-up duration is 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haihua Yuan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

June 2, 2026

First Posted (Actual)

June 8, 2026

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JY2026-039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared externally. This is a single-center, investigator-initiated exploratory clinical trial. The data sharing plan has not been established due to limited research resources, local data management regulations, and patient privacy protection requirements. Aggregated study results may be published in academic journals after study completion.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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