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

NCT07631884 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-06-08

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Haihua Yuan

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2028-12-31
Completion
2028-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07631884 on ClinicalTrials.gov