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NCT05678205 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL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

No results posted yet for this study

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

Interventions

DRUG

AB-201

NK Cell Therapy

DRUG

Cyclophosphamide

Lymphodepleting chemotherapy

DRUG

Fludarabine

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05678205 on ClinicalTrials.gov