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Clinical Study to Evaluate the Safety and Anti-Tumor Activity of AB-201

NCT07333820 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-01-12

No results posted yet for this study

Summary

HER2 is highly expressed on the surface of several cancer types, including breast and gastric/gastroesophageal junction (GEJ) cancers. Several commercially available HER2-directed oncology therapies exist; however, most patients who initially derive meaningful clinical benefit from these agents eventually relapse or experience disease progression. Accordingly, the development of safe and effective treatments for patients who have exhausted current HER2-directed options remains an important unmet medical need.

AB-201 has demonstrated direct, HER2-specific, and potent cytotoxicity against multiple tumor cell lines both in vitro and in vivo. In addition, AB-201 has shown the ability to secrete cytokines, including tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ), upon activation. Based on this emerging HER2-targeted cell therapy dataset, a HER2 CAR-NK therapy such as AB-201 may offer a safe, active, and readily available treatment option for patients with HER2-positive solid tumors.

This clinical trial will enroll subjects with HER2-positive gastric/GEJ cancers. The primary objective of the study is to evaluate the safety and tolerability of AB-201 in subjects with advanced HER2-positive gastric/GEJ cancers. The secondary objective is to assess the preliminary efficacy of AB-201, measured by objective response rate (ORR) per RECIST v1.1, in subjects with advanced gastric/GEJ cancers.

Conditions

  • Malignant Neoplasm of Stomach, Unspecified

Interventions

DRUG

AB-201 Dose escalation

1. Lymphodepletion Before administration of of AB-201, subjects will receive a lymphodepleting regimen consisting of cyclophosphamide (500 mg/m2/day IV) and fludarabine (30 mg/m2/day IV) to induce lymphocyte depletion and create an optimal environment for expansion of AB-201 in vivo. However, the lymphodepletion regimen may be adjusted according to the regulations of the institution or at the discretion of the principal investigator. 2. AB-201 Administration A total of one dose of AB-201 (adjusted for a subject's body weight) as IV infusions are planned during the treatment phase. \<Dose Levels for AB-201(adjusted for a subject's body weight)\> 1. Starting dose: 5.0 × 10\^5 cells/kg 2. 1.5 × 10\^6 cells/kg 3. 5.0 × 10\^6 cells/kg

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2026-07-31
Completion
2028-03-31

Countries

  • South Korea

Study Locations

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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 NCT07333820 on ClinicalTrials.gov