An Exploratory Study of Zanidatamab in HER2-positive Advanced Tumor After at Least One Line of Standard Therapy

Sponsor
Haihua Yuan
Study ID
NCT07631871
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Cervical Neoplasms
  • Colorectal Neoplasms
  • Endometrial Neoplasm
  • HER2 Positive Solid Tumor
  • Head and Neck Neoplasms
  • Neoplasms
  • Ovarian Neoplasms
  • Pancreatic Neoplasms
  • Solid Tumors
  • Urothelial Carcinoma (UC)

Eligibility Criteria

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

Interventions

  • Zanidatamab — DRUG
    Treatment continues until disease progression, intolerable toxicity, subject withdrawal or study termination.

Study Details

The goal of this clinical trial is to learn if Zanidatamab can treat HER2-positive advanced tumors in adults. The main question it aims to answer is: What is the objective response rate of Zanidatamab in adult patients with HER-2 positive advanced solid tumors? Participants will receive Zanidatamab intravenously on Day 1 of each 2-week treatment cycle. The dosage is 20 mg/kg per cycle.

Key Dates

First listed
Jun 8, 2026
Start date
Jun 15, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

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

Arms

  • Experimental: Zanidatamab
    Zanidatamab is administered intravenously at a dose of 20 mg/kg on Day 1 of every 2-week treatment cycle.

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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