Study on the Safety and Effectiveness of AB-201 for Advanced HER2+ Solid Tumors

Sponsor: Artiva Biotherapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05678205

Provider View

This clinical trial is testing a new treatment, AB-201, to see if it is safe and effective for patients with advanced HER2+ solid tumors, such as certain types of breast and gastric cancers.

Patient Parameters

Program Overview

The study is being conducted in two phases. In Phase 1, researchers will focus on determining if AB-201 is safe and well-tolerated in patients with advanced HER2+ solid tumors. In Phase 2, the goal is to evaluate how well AB-201 works in treating these tumors. Participants will receive up to three doses of AB-201 and will have regular check-ups to monitor their overall health and how their tumors respond to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a confirmed diagnosis of HER2+ breast or gastric/gastroesophageal junction (GEJ) cancer, with specific test results within the last 6 months.
  • Have advanced or metastatic HER2+ breast or gastric/GEJ cancer that has not responded to standard treatments or for which no standard treatment is available.
  • Have received previous cancer treatments: at least two prior treatments for breast cancer, or at least one for gastric/GEJ cancer. Patients with certain test results must have had previous HER2-targeting therapy.

Exclusion Criteria

  • Have or had another type of cancer besides the one being studied.
  • Have significant heart disease.
  • Have active cancer spread to the brain or central nervous system unless it has been stable for at least 3 months.
  • Have unresolved side effects from previous cancer treatments.
  • Have ongoing uncontrolled infections requiring treatment.
  • Have a history of allergic reactions to certain chemotherapy drugs.
  • Are pregnant or breastfeeding, or not willing to use birth control during the study and for 6 months after the last dose of AB-201.
  • Have severe disease progression or health decline within 2 weeks before starting the treatment.

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