A Clinical Trial of the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced HER2+ Solid Tumors
NCT05678205 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL
Last updated 2025-07-30
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
- DRUG
-
AB-201
NK Cell Therapy
- DRUG
-
Lymphodepleting chemotherapy
- DRUG
-
Lymphodepleting chemotherapy
Sponsors & Collaborators
-
Artiva Biotherapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Thorsten Graef, MD, Ph.D · Artiva Biotherapeutics
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-01
- Primary Completion
- 2027-04-30
- Completion
- 2027-04-30
- FDA Drug
- Yes
Countries
- United States
- South Korea
Study Locations
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