NCT05678205

A Clinical Trial of the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced HER2+ Solid Tumors

A Multicenter, Open-label, Phase 1/2 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced HER2+ Solid Tumors

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Artiva Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial will enroll subjects with HER2+ solid tumors and is conducted in two phases. The primary objective of Phase 1 is to determine the safety and tolerability of AB-201 in subjects with advanced HER2+ solid tumors. The primary objective of Phase 2 is to evaluate the efficacy of AB-201. Subjects will receive up to 3 doses of AB-201, followed by scheduled assessments of overall health and tumor response.

Conditions

• Breast Cancer
• Gastric Cancer
• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	AB-201	NK Cell Therapy
DRUG	Cyclophosphamide	Lymphodepleting chemotherapy
DRUG	Fludarabine	Lymphodepleting chemotherapy

Timeline

• Start date: 2023-08-01
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2023-01-10
• Last updated: 2025-07-30

Locations

2 sites across 2 countries: United States, South Korea

Regulatory

• FDA-regulated drug study