MedTrace Logo

Trastuzumab Rezetecan in Advanced Solid Tumors Refractory to Standard Therapies

NCT07309770 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-12-30

No results posted yet for this study

Summary

This study is a single-center, multi-cohort, phase II clinical trial. Eligible patients with HER2-positive advanced solid tumors were enrolled after providing informed consent. A total of 90 patients were allocated into three cohorts (30 patients each): those with Extramammary Paget's Disease (EMPD), rare solid tumors, or urothelial carcinoma, who had experienced failure of standard treatment or for whom no standard treatment was available. The participant recruitment period was 12 months, and the follow-up duration was 12 months. All patients received Trastuzumab Rezetecan (SHR-A1811) at a dose of 4.8 mg/kg administered every three weeks (q3w). They were followed until disease progression, withdrawal from the study, loss to follow-up, or death, whichever occurred first. Tumor response was assessed radiologically every 6 weeks during treatment. Safety follow-up was conducted 30 days after the last dose, followed by survival follow-up every 3 months thereafter.

Conditions

  • Urachal Cancer
  • Advanced Solid Tumor Cancer
  • Antibody-drug Conjugates

Interventions

DRUG

SHR-A1811

Trastuzumab Rezetecan (SHR-A1811) is administered at a dose of 4.8 mg/kg every 21 days (q3w), constituting one treatment cycle.

DRUG

Trastuzumab Rezetecan

Patients who have failed standard therapy are treated with Trastuzumab Rezetecan

Sponsors & Collaborators

  • Sheng Zhang

    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
2025-12-18
Primary Completion
2027-09-11
Completion
2028-03-11

Countries

  • China

Study Locations

More Related Trials

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 NCT07309770 on ClinicalTrials.gov