NCT07333820

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

Clinical Study to Evaluate the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced HER2 Positive Gastric/Gastroesophageal Junction(GEJ) Cancer

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study designed to evaluate the safety, tolerability, and efficacy of AB-201 in subjects with advanced HER2 positive gastric/GEJ cancers. Up to 18 subjects will be enrolled, and the study will be conducted by dose escalation. During the Dose Escalation stage of this study, up to 3 escalating dose levels of AB-201 will be explored. The maximum tolerated dose (MTD) and/or maximum administered dose (MAD) for AB-201 will be defined as the highest dose level at which not more than 1 of 6 subjects in a cohort experiences a dose-limiting toxicity (DLT) as outlined below. The highest dose administered becomes the MAD if the MTD is not reached. AB-201 is a cryopreserved, infusion-ready suspension cell therapy comprised of ex vivo-expanded allogeneic cord blood-derived NK cells that have been genetically modified to express a HER2-directed CAR and secrete IL-15. AB-201 will be administered as a single IV infusion starting at 48 hours (but no more than 7 days) after completion of the lymphodepletion regimen. A 28-day observation period will then occur, at the end of which all relevant safety data will be reviewed. Study participation for each subject begins with up to 28 days (1 month) of screening following written informed consent, then lymphodepletion treatment, followed by AB-201. All subjects will be monitored for a total duration of 18 months of follow-up from the administration of AB-201. Safety will be assessed according to the Schedule of Activities by monitoring AEs (including DLTs, AEs of special interest \[AESIs\], and serious AEs \[SAEs\]), concomitant medications, physical examinations, ECOG performance status, acute GvHD, vital signs, and laboratory test findings. As an additional safety measure, Bayesian stopping bounds will be employed for the duration of the study. Disease assessments will be performed according to the Schedule of Activities per RECIST v1.1. Imaging scans (CT or MRI) will be performed at Months 1, 2, 3, 6, 9, 12, 15, and 18 for efficacy assessments.

Conditions

• Malignant Neoplasm of Stomach, Unspecified

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-07-01
• Completion: 2028-03-01
• First posted: 2026-01-12
• Last updated: 2026-01-12

Locations

1 site across 1 country: South Korea