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

Sponsor
Haihua Yuan
Study ID
NCT07631884
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jun 8, 2026
Start date
Jun 15, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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. ]

Central Contacts

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